Abstract
Introduction:
Mindfulness interventions can improve a broad range of patient outcomes, but traditional mindfulness-based interventions are time and resource intensive. Emerging evidence indicates brief, single-session mindfulness interventions can also improve patient outcomes, and brief mindfulness interventions can be embedded into medical care pathways with minimal disruption. However, the direct impact of a brief mindfulness intervention on patients’ pain while waiting in the clinic waiting room remains unexamined.
Objective:
A series of three, pilot, randomized controlled trials (RCTs) were conducted to examine the impact of a brief, audio-recorded, mindfulness intervention on patients’ pain in the clinic waiting room.
Method:
Study 1 examined an 8-min mindfulness recording delivered before a provider visit; Study 2 examined a 5-min mindfulness recording after a provider visit; and Study 3 examined a 4-min mindfulness recording before a provider visit. Time- and attention-matched control conditions were used in each study. Studies 1 and 2 were conducted in an academic cancer hospital. Study 3 was conducted at a walk-in orthopedic clinic. Pain intensity was measured in each of the three studies. Anxiety and depression symptoms were measured in Studies 2 and 3. Pain unpleasantness was measured in Study 3.
Results:
A brief (i.e., 4- to 8-min), audio-recorded mindfulness intervention decreased patients’ pain intensity in the clinic waiting room, whether delivered before (Study 1 Cohen’s d=1.01, Study 3 Cohen’s d=0.39) or after (Study 2 Cohen’s d=0.89) a provider visit. Mindfulness had a significant effect on anxiety symptoms in both studies in which it was measured. No effect on depression symptoms was observed.
Conclusions:
Results from these three pilot RCTs indicate brief, audio-recorded, mindfulness interventions may be capable of quickly decreasing clinical symptoms. As such, embedding brief, audio-recorded, mindfulness interventions in clinic waiting rooms may have the potential to improve patient outcomes. The continued investigation of this intervention approach is needed.
Clinical Trial Registrations:
NCT04477278 and NCT06099964
Introduction
Traditional mindfulness-based interventions span 8 weeks and effectively decrease pain and psychological distress. 1 –3 However, 8 weeks of mindfulness training can be too burdensome for many patients to attend 4,5 and too resource-intensive for many providers to offer. 6,7 Consequently, many patients have limited access to mindfulness training. Mindfulness training could be made more accessible by shortening the training duration and embedding the training in common medical care pathways. Recent evidence indicates brief mindfulness interventions can be embedded into medical care pathways with minimal disruption and can improve clinical outcomes. 8 –17
Brief, provider-led, mindfulness interventions are effective. In three large randomized controlled trials (RCTs), 15- to 20-min mindfulness interventions immediately decreased pain and anxiety symptoms in hospitalized patients (n = 244) 16 and adults preparing for a total knee or hip replacement surgery (n = 285, n = 118). 14,15 In the two RCTs involving adults preparing for a total knee or hip replacement, the brief mindfulness intervention before surgery was also found to improve pain-related outcomes 4 15 and 6 weeks 14 after surgery. However, not every medical setting has a provider with the interest, training, or time to deliver a mindfulness intervention. Fortunately, brief, audio-recorded mindfulness interventions also appear effective.
A 3-min, audio-recorded, mindfulness intervention was recently found to decrease pain intensity and pain medication desire among adults preparing for a total knee or hip replacement (n = 127). 13 However, this 3-min intervention was delivered during nurses’ one-on-one consultation time, placing an additional burden on the nurses. In another RCT involving adults with cancer (n = 99), a 10-min audio-recorded mindfulness intervention was delivered partially in the clinic waiting room (i.e., 3-min) and partially during an exercise session warm-up activity (i.e., 7-min). 11 Results indicated mindfulness was associated with greater treatment satisfaction. However, since the exercise specialist delivered the 7-min mindfulness recording while participants walked on a treadmill, this intervention strategy increased the exercise specialists’ burden. Medical providers are incredibly busy; increasing their workload by just a few minutes with a brief mindfulness intervention limits the intervention’s feasibility. Provider burden could be eased by delivering the brief mindfulness intervention entirely in the clinic waiting room by non-provider staff.
To date only two known RCTs have examined the impact of an audio-recorded mindfulness intervention delivered in a clinic waiting room. The first was a 15-min intervention for adults with cancer (n = 223) that combined mindfulness and acupressure instruction before a chemotherapy treatment. 17 Results indicated the combination intervention significantly decreased patients’ stress and anxiety symptoms but not their pain. The second RCT was a pilot project examining an 8-min mindfulness intervention for patients seeking osteopathic manipulation (n = 39). 12 Results indicated mindfulness increased patients’ treatment satisfaction. Together, these two studies support the feasibility and therapeutic potential of delivering a brief mindfulness intervention in the clinic waiting room. However, the direct, clinical impact of a brief, audio-recorded mindfulness intervention on patients’ pain while waiting in the clinic waiting room remains poorly characterized.
The purpose of this manuscript is to add to the literature on mindfulness interventions delivered in the clinic waiting room. Reported here are three pilot RCTs examining the impact of brief (4-, 5-, and 8-min) mindfulness interventions on pain and two common, psychological pain comorbidities: anxiety symptoms and depression symptoms. 18,19 The first two pilot RCTs were conducted in the waiting room of an academic cancer hospital’s wellness center. Study 1 examined the impact of an 8-min, audio-recorded mindfulness intervention before a provider visit. Study 2 examined the impact of a 5-min, audio-recorded mindfulness intervention after a provider visit. The third RCT was conducted in the X-ray waiting room of a privately owned orthopedic clinic. In Study 3, the 4-min audio-recorded mindfulness intervention was delivered before patients’ X-rays and provider evaluation. Given prior evidence that mindfulness decreases pain and psychological distress (i.e., anxiety and depression symptoms), 1,2,8 –17 we hypothesized that mindfulness would decrease clinical symptoms relative to time- and attention-matched control conditions.
Materials and Methods
Procedures
Results are from three, independent, single-site, two-arm, parallel-group, pilot RCTs. Trial registrations exist for Study 1 (NCT04477278) and Study 3 (NCT06099964). No registration was created for Study 2. The local Institutional Review Board approved all procedures for all three studies.
Participants in Studies 1 (n = 37) and 2 (n = 26) were patients seeking treatment at a wellness center in an academic cancer hospital in the American Mountain West. Participants in Study 3 (n = 80) were patients at an orthopedic walk-in clinic waiting for an X-ray in the American Southeast. These sites were selected because both (1) had an established relationship with the first author, (2) previously conducted research examining brief mindfulness interventions within their respective patient populations, 11,12,20 and (3) expressed a willingness to collaborate with the research team on the present studies. As pain is the chief complaint among patients at both sites and wait times are not uncommon at either, these clinical settings were considered optimal for the purposes of testing a brief, audio-recorded, pain management intervention in the waiting room.
In each study, participating patients were given an Apple iPad (Apple Inc., Cupertino, CA) and some closed-back monitoring headphones (Audio-Technica U.S., Inc., Stow, OH). All study procedures were embedded in the Qualtrics survey platform (Qualtrics, Provo, UT) so that they could be completed on the tablet. Qualtrics’ internal randomization function was used to allocate participants to the Mindfulness or Control conditions (1:1) in each study. Participants and study personnel were blind to treatment condition. Study interventions were matched in terms of format (individual), duration, and frequency (once). All interventions were delivered via audio recording. Voice recordings were made by the same individual for standardization. Prior to study initiation, it was made clear to all clinic staff and providers that study procedures should not disrupt normal clinic flow. Across all three studies, research procedures were immediately discontinued in any instance in which they conflicted with normal clinic operations.
Study 1 involved patients seeking osteopathic manipulation from a single provider in an academic cancer hospital. Immediately after checking in for their appointment, clinic administrative staff reviewed the consent cover letter with participants, documented their medical record number, and gave them a study tablet and set of headphones. Participants were then free to sit anywhere in the clinic waiting room to complete the study procedures. In conversations with the provider, it was determined that an 8-min audio recording could be seamlessly integrated into the clinic flow as most patients arrived >10 min prior to their treatment session. As such, in this study, an 8-min mindfulness recording was compared with an 8-min recording about the history of osteopathic medicine. All 8 min of the mindfulness recording were dedicated to a mindful breathing practice. The mindful breathing practice guided participants to focus attention on the breath while metacognitively monitoring and accepting thoughts, negative emotions, and physical sensations. This mindfulness practice script was a brief adaptation of a validated script used in prior research on mindfulness in medical settings. 14 –16 In the recording, mindfulness was not introduced or defined; why mindfulness may be useful for pain management was not justified. The history of osteopathy recording introduced participants to the founder of osteopathic medicine, Andrew Taylor Still, and his healing philosophy.
Study 2 involved patients seeking various treatments (i.e., acupuncture, massage, osteopathic manipulation) at an academic cancer hospital’s wellness center. Immediately after their appointment, the provider that just delivered treatment introduced their patient to the study, reviewed the consent cover letter with each patient willing to participate, and gave each participant a study tablet and set of headphones. Participants were then free to sit anywhere in the clinic waiting room to complete the study procedures. Once done, they returned the tablet and headphones to the administrative staff before leaving the clinic. In conversations with the providers, it was determined that patients may be willing to listen to a 5-min audio recording after their visit. A 5-min recording was thought to be brief enough to not discourage patients from participating before leaving the clinic but long enough to confer therapeutic value. In Study 2, a 5-min mindfulness recording was compared with a 5-min recording about integrative healthcare. All 5 min of the mindfulness recording were dedicated to a mindful breathing practice. This practice was a brief adaptation of a validated script used in prior research on mindfulness in medical settings. 14 –16 It closely approximated the practice used in Study 1. Similar to Study 1, mindfulness was not introduced or defined; why mindfulness may be useful for pain management was not justified. The integrative healthcare recording defined integrative healthcare and explained how complementary healthcare options can be integrated into traditional medical care.
Study 3 involved patients at an orthopedic walk-in clinic. After patients checked in for an X-ray and sat down in the waiting area, a research assistant approached them, introduced the study, and invited them to participate. Each interested patient was given a set of headphones and a study tablet on which they reviewed the consent cover letter before beginning the study procedures. The 4-min intervention format used in this study was informed by two previous studies examining ≤3-min, provider-led, mindfulness interventions. 13,21 As no provider was used to deliver the intervention in Study 3, the study team determined that adding an extra minute of audio-recorded introduction would be valuable given the lack of real-time provider feedback. In study 3, a 4-min mindfulness recording was compared with a 4-min recording about injury management strategies. The mindfulness recording included a 1-min introduction to mindfulness, a 1-min and 30-sec mindful breathing practice, and a 1-min and 30-sec mindfulness of pain practice. The mindful breathing practice was an even briefer adaptation of the practice instructions used in Studies 1 and 2 and validated in prior research on mindfulness in medical settings. 14 –16 The mindfulness of pain practice was a brief adaptation of the core mindfulness practice used in Mindfulness-Oriented Recovery Enhancement. 22 –25 It consisted of instruction on how to “zoom in” to deconstruct pain into its constituent physical, emotional, and cognitive parts, precisely map each sensation’s spatial location, and then “zoom out” to non-reactively observe changes in sensation. The injury management education recording introduced a common pain coping technique called “P.O.L.I.C.E.” (i.e., protection, optimal loading, ice, compression, and elevation). 26
Measures
Acute clinical symptoms were assessed immediately before and after each intervention. Pain intensity (“How much pain do you have?”), pain unpleasantness (“How unpleasant is your pain?”), anxiety symptoms (i.e., “How nervous, anxious or on edge do you feel, right now”) and depression symptoms (i.e., “How down, depressed, or uninterested in life do you feel?”) were each measured with a single item rated on a numeric rating scale (i.e., 0–10). This is a widely used approach to quickly measuring clinical symptomology. 27,28 The anxiety symptoms item was adapted from the widely used GAD-2, 29 and the depression symptoms item was adapted from the PHQ-2. 30 It is important to emphasize that these two items should not be interpreted as indicators of the presence or absence of a clinical diagnosis, but as the degree to which the respective clinical symptoms were present at the time of assessment. Pain intensity was measured in each of the three studies. Anxiety and depression symptoms were measured in Studies 2 and 3. Pain unpleasantness was only measured in Study 3 and was the prespecified primary outcome.
Data analyses
All data analyses were performed in SPSS. We used t-tests and chi-square tests to examine group equivalency at baseline. Generalized linear mixed modeling (GLMM) with robust estimation was used to examine intervention-related changes in the clinical symptoms. In accordance with the classical analysis of covariance approach endorsed by Frison and Pocock, 31 baseline values were covaried to ensure that comparisons of post-randomization values by condition were independent of baseline differences. Then, t-tests were used for post-hoc examination of within-group changes in clinical symptomology. The t-test p-values were adjusted using the Holm–Bonferroni sequential correction approach. Finally, minimally significant pain differences (i.e., >15%) by condition were calculated. 32
Sample size determinations
The methods used to determine study sample sizes evolved over the course of these three studies. Sample sizes in Studies 1 and 2 were informed by effect size estimates; 33 the sample size in Study 3 was informed by best practice recommendation. 34 First, for Studies 1 and 2, previously reported effect size estimates from a brief (i.e., 3-min), mindfulness intervention targeting acute pain with an audio recording ranged from 0.35 to 0.45 for pain intensity and 0.45 to 0.56 for pain unpleasantness. 13 Effect sizes from longer, single-session (i.e., 15–20 min) mindfulness interventions ranged from 0.43 to 0.59 for pain intensity and 0.58 to 0.70 for pain unpleasantness. For a pilot study examining an intervention capable of a similar effect (i.e., 0.30 to 0.40), the total sample size recommendations ranged from 18 to 24 (assuming β = 0.80) and from 21 to 29 (assuming β = 0.90), respectively. 33 However, more recent sample size recommendations suggest that at least 30 participants per treatment arm is preferable for a feasibility clinical trial. 34 This recommendation guided our sample size in Study 3. Studies 1 and 2 were conducted prior to the authors becoming aware of the most recent clinical feasibility trial recommendations; Study 3 was conducted after.
Results
Study 1 results
Between 03/25/2019 and 08/27/2019, 57 patients were invited to listen to an 8-min audio recording in the waiting room of an academic cancer center’s wellness center before beginning their osteopathic manipulation session. Presented here is a subsample of participants from the original outcome study 12 who completed a measure of pain intensity prior to starting their osteopathic manipulation session (n = 37). Participants did not differ at baseline by age, sex, cancer diagnosis, primary pain location, or pain intensity (t = 1.22, p = 0.23) by condition (see Tables 1 and 4). Demographic information was not available for one participant in the mindfulness condition.
Study 1 Participant Characteristics by Condition
SD, Standard deviation.
Study 3 Participant Characteristics by Condition
GLMM indicated participants in the Mindfulness condition reported significantly less pain intensity than participants in the History of Osteopathy condition (Table 2). The t-tests (Table 3) indicated participants in the Mindfulness condition reported significant decreases in pain intensity. The pain intensity effect size was in the large range. The change in pain intensity among History of Osteopathy participants was not significant after multiple comparison correction. Finally, 67% (12/18) of Mindfulness participants reported a >15% pain intensity reduction compared to only 32% (6/19) of the History of Osteopathy participants.
Between-Group Contrasts for each Variable in each Study (Adjusted Analyses) *
Estimates are from linear mixed models adjusting for baseline score.
CI, Confidence interval.
Within-Group Contrasts for Each Variable in Each Study
Bold used to indicate p-values below Holm–Bonferroni corrected alpha levels.
Study 1: p 1<.025, p 2<.05.
Study 2: p 1<.008.
Study 3: p 1<.006, p 2<.0125, p 3<.0188.
CI, Confidence interval; SD, Standard deviation.
Study 2 results
Between 06/21/2022 and 03/29/2023, 57 participants were invited to listen to a 5-min recording in the wellness center’s waiting room after seeing their provider. Four participants were approached twice in that time period and one participant three times, making a total of 63 unique patient encounters. Patients agreed to participate in 52 (82.5%) of those encounters. In 26 (i.e., 50%) of those 52 encounters, patients provided baseline symptom ratings and listened to the audio recording. No participant completed the study procedures twice, and in only one instance did a participant who listened to the recording provide no outcome data. Reasons for study discontinuation were not recorded. Of the 26 participating patients, 13 were randomized to the Mindfulness condition and 13 to the Integrative Healthcare Education condition.
There were no between-group differences in the type of treatment participants had just received at the wellness center (χ 2 = 2.03, p = 0.36). In the Integrative Healthcare Education condition, five participants received massage, seven acupuncture, and one osteopathic manipulation; In the Mindfulness condition, eight participants received massage and five acupuncture. Demographic data was not collected from the Study 2 participants, but pain intensity (t = 0.36, p = 0.72), anxiety symptoms (t = 0.09, p = 0.93), and depression symptoms (t = 1.43, p = 0.17) did not differ by condition at baseline (see Table 4 for mean values).
GLMM indicated participants in the Mindfulness condition reported significantly less pain intensity and anxiety symptoms than participants in the Integrative Healthcare Education condition (Table 2). Depression symptom scores did not differ by condition. The t-tests (Table 3) did not reveal any significant within-group changes in any of the measured clinical symptoms after multiple comparison correction. However, of the mindfulness participants, 62% (8/13) reported >15% pain intensity reduction compared to only 15% (2/13) of control participants. Changes in anxiety and depression symptoms were both non-significant, but effect size estimates were in the small to medium range.
Study 3 results
Over 8 days between 11/13/2023 and 12/4/2023, 197 patients were approached in the X-ray waiting room of an orthopedic clinic. A total of 100 patients agreed to participate in the study and 97 declined. Of those that declined, the most common reason for declining was a lack of interest in study participation (n = 70; e.g., would rather read a book). Other reasons for declining included hearing impairment (n = 4), currently experiencing too much pain (n = 3), and already working with a pain specialist (n = 3). Of those who agreed to participate, 20 (20%) were taken for their X-ray before completing the study procedures. These 20 participants were removed from subsequent analyses, leaving a final sample of 80 participants. Complete data were available from 70 of the 80 participants.
Demographic information was provided by 52 (73%) participants. Participants did not differ by age, sex, or race/ethnicity by condition (Table 4). All participants provided clinical symptoms at baseline. Pain unpleasantness (t = 1.40, p = 0.17), pain intensity (t = 1.16, p =0.25), anxiety symptoms (t = 0.19, p =0.8), and depression symptoms (t = 1.29, p = 0.20) did not differ by condition at baseline (see Table 4 for mean values).
GLMM indicated participants in the Mindfulness condition reported significantly less pain unpleasantness and pain intensity than participants in the Injury Management condition (Table 2). Anxiety and depression symptom scores did not differ by condition. The t-tests (Table 3) indicated participants in the Mindfulness condition reported significant decreases in pain unpleasantness and anxiety symptoms. The pain unpleasantness and anxiety symptom effect sizes were in the medium-to-large range. No significant within-group changes in any of the measured clinical symptoms were observed in the Injury Management condition. A >15% reduction in pain intensity was reported by 31% (11/35) of Mindfulness participants, but only 6% (2/35) of Injury Management participants. A >15% reduction in pain unpleasantness was reported by 46% (16/35) of Mindfulness participants, but only 23% (8/35) of Injury Management participants.
Discussion
Pain is one of the most common reasons for seeking medical care; however, pain relief is often delayed. Upon arriving at a clinic for assessment or treatment, patients typically wait in the clinic waiting room for more than 15 min before seeing a provider. 35,36 For patients referred to pain management, lengthy waitlists can delay treatment by weeks or months. 37,38 In contrast, results from these three pilot RCTs suggest these gaps in the care pathway need not be idle. Patients could be offered a pain management intervention as soon as they enter the clinic waiting room and/or as soon as their provider visit ends.
Specifically, we found a brief (i.e., 4- to 8-min), audio-recorded mindfulness intervention provided patients with immediate pain relief in the clinic waiting room, whether delivered before or after a provider visit. Attesting to the potential generalizability of these results, pain reductions were observed in two very different settings (i.e., the wellness center in an academic cancer center vs. a privately owned orthopedic walk-in clinic) and with very different patient populations (e.g., cancer patients, chronic pain patients, patients with acute musculoskeletal injuries) experiencing markedly different levels of pain at baseline: Study 2: x̄ ≈ 2.2, Study 1: x̄ ≈ 4.5, and Study 3 = x̄ ≈ 6.1.
Effect size estimates indicate statistically meaningful pain decreases are possible, even with brief, audio-recorded mindfulness interventions. Pain intensity effect sizes were large for the 5- and 8-min mindfulness interventions in the cancer hospital’s wellness center. For the 4-min mindfulness intervention in the orthopedic clinic, the pain intensity effect size was in the small to medium range, but the pain unpleasantness effect size was in the medium to large range. Of greater clinical significance, 39 –41 pain intensity decreased by ∼1 point on a numeric rating scale in both the 5-min (−41%) and 8-min (−23%) mindfulness interventions in the cancer hospital’s wellness center. In both studies, approximately two out of three patients reported a clinically significant reduction in pain (>15%). 32 Pain intensity decreases were more modest at the orthopedic clinic, decreasing by an average of 0.4 points (−7%). However, mindfulness decreased orthopedic patients’ pain unpleasantness by an average of 1.2 points (−18%). In the orthopedic clinic, one in three patients reported a clinically significant reduction in pain intensity; nearly one in two patients reported a similar reduction in pain unpleasantness. This pattern of results is consistent with findings from a previous RCT examining the impact of a nurse-led, 3-min, audio-recorded mindfulness intervention on knee and hip replacement patients’ (n = 127) pain unpleasantness and pain intensity. 13 In the previous study, two different styles of mindfulness practice were compared: mindfulness of breath and mindfulness of pain. Mindfulness of breath decreased surgical patients’ pain unpleasantness by 1.0 points (−24%) and pain intensity by 0.6 points (−15%). Mindfulness of pain decreased pain unpleasantness by 0.7 points (−16%) and pain intensity by 0.5 points (−12%). Taken together, these studies suggest brief, audio-recorded mindfulness interventions may be useful adjunctive treatments for pain, even when no provider is available.
Anxiety and depression symptoms, commonly comorbid with pain, 18,19 were also examined in Studies 2 and 3. Although the results were not as consistent as those observed for pain, mindfulness had a significant effect on anxiety symptoms in both studies. These findings are similar to a previous RCT of a combination mindfulness and acupressure intervention delivered to cancer patients in the clinic waiting room. 9 No effect on depression symptoms was observed in either study, which could be explained by the fact that depression is not an acute mood disorder as opposed to pain and anxiety that can fluctuate greatly according to a variety of factors. Moreover, depression symptom levels were relatively low across groups in the studies presented here. In Study 2, participants in the Mindfulness condition reported significantly less anxiety symptoms after listening to the recording than those in the Control condition. Furthermore, while the within-group contrast was non-significant (p = 0.056) in this small pilot sample, mindfulness decreased the average anxiety symptom score by 43% and the within-group effect size was in the medium to large range (d = 0.62). In study 3, no significant between-group difference was observed as anxiety symptom scores decreased in both the Control (Δ = −0.40) and Mindfulness (Δ = −0.83) conditions. However, within-group contrasts revealed that only the decrease in anxiety symptoms in the Mindfulness participants was significant and the effect size fell in the medium range (d = 0.49). With anxiety symptom score reductions approaching one point and medium to large effect sizes observed in both studies, continued investigation of brief mindfulness interventions for anxiety symptoms in the waiting room appears warranted.
While these early results are promising, further research is needed to advance our understanding of how to deliver mindfulness for pain management in the clinic waiting room. Specifically, an examination of different styles of mindfulness practice is needed. In Studies 1 and 2, a traditional mindful breathing practice was selected for participants due to its perceived accessibility. Inviting pain patients to focus on their breath was thought to be easier for them than focusing on their bodies—as in a body scan practice—since it was the pain in their bodies they were seeking to avoid through treatment. However, emerging evidence suggests being mindful of pain, itself, may have therapeutic value, 13,15 which is why Study 3 combined mindful breathing instruction with mindfulness of pain instruction. Another future area of study is determining the optimal length of mindfulness practice in the clinic waiting room. In the three studies reported here, the length of mindfulness practice varied considerably (i.e., 4–8 min). This variability resulted from the core tension in this intervention model: avoiding disruption to the clinic operations while also seeking to provide a therapeutic “dose” of mindfulness. Examining whether clinical outcomes differ by mindfulness practice length would be an important next step in this research program.
Future research may also wish to explore whether there are meaningful differences between providing mindfulness in the clinic waiting room before the provider visit as compared to after the provider visit. For example, would the Study 2 recording be as effective if delivered before the visit; would the Study 1 and Study 3 recordings work just as well after? Interestingly, in Studies 1 and 2, participants reported similar decreases in pain intensity despite the mindfulness practices being of different lengths and the baseline pain levels being unequal as participants in Study 2 had just completed an integrative medicine treatment (i.e., acupuncture, massage, osteopathic manipulation), whereas participants in Study 1 had yet to begin one. To find a mindfulness recording decreased pain even after an integrative medicine session is noteworthy in its own right and points toward the need for future research on combination treatments (e.g., acupuncture + mindfulness; massage + mindfulness). Furthermore, it may be that the different intervention points (i.e., before vs. after) could be used for different therapeutic purposes. For example, the pre-visit mindfulness recording could be used to prepare the patient for their provider contact by decreasing pain in the service of improving communication. Comparatively, the post-visit recording could be used (1) to increase the likelihood that patients leave their provider visit having experienced some pain relief if an active treatment was not provided during the visit, or (2) as an alternative to having a provider teach patients how to mindfully manage pain should time constraints preclude such instruction during the standard visit, or the provider not feel comfortable introducing the mindful pain management skill(s).
Future research is also needed to address current study limitations. First, given the pilot nature of these projects, the small sample sizes limit generalizability. Relatedly, Study 2’s results should be interpreted with caution given the absence of pre-registration and the lack of participant demographic data. Now, large randomized controlled trials are needed to confirm or refute these findings. Of note, we attempted to control for non-specific features such as the level of engagement 42,43 or placebo expectancy 44,45 by using an active control arm in each study. However, it was recently suggested that placebo expectancy may drive immediate pain reductions and that mindfulness-specific benefits may emerge after a longer duration of training. 46 Measuring mindfulness and adding a usual care group will help strengthen follow-up studies of mindfulness interventions delivered in the clinic waiting room.
Second, while conducting these three studies in collaboration with three different sets of providers allowed for a broader proof-of-concept investigation, it also resulted in different levels of access to participant information by study. In Study 1, participants’ medical record numbers were identifiable, and as such their medical history could be reviewed in greater detail (e.g., primary pain location). However, due to an idiosyncrasy of the medical record system, information about patients’ race was not provided for Study 1. In Studies 2 and 3, participants’ medical record information was not available. In Study 2, funding was not available to pay for medical record data extraction. In Study 3, IRB approval to access medical records was not pursued for purposes of expediency. Additionally, at the discretion of the collaborating providers in Study 2, no demographic data was captured to streamline the research procedures, as it was hoped that funds would become available later to extract demographic information from participants’ medical records. In Study 3, as no medical record access was anticipated, participants were asked to provide basic demographic data. To address these limitations, future studies of mindfulness-based waiting room interventions are encouraged to capture more comprehensive and uniform participant characteristics. A common data elements approach, akin to the HEAL initiative efforts, 47 may be useful in this regard.
Third, we prioritized a brief assessment strategy (i.e., a single question per symptom) to minimize disruption in the clinical environment. Although acute pain is commonly measured in a brief manner, 27 the quantification of complex affective disorders such as anxiety and depression, along with their respective symptoms, presents a more intricate challenge. Thus, it should be emphasized that the large effect sizes observed in this study may be a consequence of employing non-standardized outcome measures, potentially obscuring the true effect. Conversely, the absence of statistically significant differences in depression symptoms in these studies may also be attributable to the use of non-standardized methods for quantifying the intricacies of depression. More robust, multi-item measurement tools would likely give more stable pain, anxiety, and depression estimates and should be considered for future trials of brief interventions in clinic waiting rooms. Similarly, to keep the study procedures brief, no formal assessment of participants’ perceptions of the mindfulness interventions was conducted. Future studies are encouraged to give participants the opportunity to provide feedback about the mindfulness intervention either through a free response text box embedded in the survey flow or in a follow-up interview with research assistant. This information could be used to further refine this intervention model.
Finally, analgesic medication use was not measured. Although randomization is meant to balance group differences, pain-related pharmacologic regimens could have influenced those results. On the other hand, mindfulness interventions are used to mitigate analgesic consumption, and it would be important to include this outcome in future trials of brief mindfulness interventions in this setting.
Conclusion
Idle gaps exist in many medical care pathways that could be leveraged for therapeutic benefit. 8 –10 Time in the clinic waiting room is one such example. Results from these three pilot RCTs indicate brief (i.e., 4- to 8-min), audio-recorded, mindfulness interventions are capable of quickly decreasing clinical symptoms. As such, embedding brief, audio-recorded, mindfulness interventions in clinic waiting rooms may have the potential to transform idle time into time for healing. A continued investigation of this intervention approach is needed.
Footnotes
Authors’ Contributions
A.W.H.: Conceptualization, methodology, data analyses, and writing—original draft. R.W.Z.: Conceptualization, methodology, and investigation for Studies 1 and 2. B.S., M.Z., and S.W.: Conceptualization, methodology, and investigation for Study 2, and writing—reviewing and editing. A.D. and P.R.W.: Conceptualization, methodology, and investigation for Study 2, and writing—reviewing and editing. C.C. and G.M.: Writing—reviewing and editing.
Author Disclosure Statement
The other authors declare they have no conflicting interests.
Funding Information
A.W. H. was supported by grant number
Ethics Statement
The University of Utah’s Institutional Review Board approved all study procedures for Studies 1 (00116896) and 2 (00085446). The Florida State University approved all study procedures for Study 3 (00004419).
Informed Consent
This study was performed in accordance with the ethical standards stipulated by the 1964 Declaration of Helsinki.
Data Availability Statement
Data will be made publicly available upon publication.
Supplementary Material
Pain of Waiting Consort Checklist
Study 1 CONSORT FlowChart 1_6_2024
Study 2 CONSORT FlowChart 1_6_2024
Study 3 CONSORT FlowChart 1_6_2024
References
Supplementary Material
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