Abstract
Background:
Dental injections are among the most aversive procedures in pediatric dentistry. Hence, any effort aimed at reducing injection pain in children is valuable. Few studies have examined the effect of acupressure on injection pain in pediatric dentistry.
Objective:
To investigate the effect of acupressure at the LI4 point on the injection pain of local anesthesia in children.
Design, Setting, and Participants:
This is a randomized, triple-blind, crossover clinical trial. Children were randomly allocated into two groups. One group received acupressure at LI4 in the first session and sham acupressure in the second session, while the other group received the interventions in the reverse order. Local anesthesia was administered after the acupressure treatment. Pain intensity was assessed using the Face, Legs, Activity, Cry, Consolability scale (FLACC) and the Faces Pain Scale-Revised (FPS-R).
Interventions:
Acupressure and sham acupressure.
Main Outcome and Measures:
The main outcome measure was the pain level during injection.
Results:
Twenty-four children participated (11 boys, 13 girls) with a mean age of 7.16 ± 1.34 years. The mean pain level assessed by FLACC was reduced with acupressure, but the reduction was not statistically significant. Pain reduction with acupressure assessed by FPS-R was also not significant.
Randomizations:
Flip of a coin.
Conclusion:
In this study, there was no significant difference in pain levels between the acupressure and sham acupressure group. Consequently, the reduction of dental injection pain through acupressure was not observed. Furthermore, research in the field of dentistry, exploring various acupoints, is necessary to draw more conclusive results.
INTRODUCTION
The injection of local anesthesia remains one of the most painful and stressful steps in dentistry for children. Pain control during dental procedures is a crucial aspect of behavior guidance in pediatric dentistry. If children experience pain during treatment, there is an increased likelihood of developing a negative attitude toward future sessions.1,2 Previous studies have found that dental injections provoke the most significant negative responses in children; these responses tend to become more pronounced after four or five consecutive injections. 2 Therefore, it is essential to minimize pain and discomfort at each appointment.
Several methods have been introduced to reduce dental injection pain in children, which can be divided into two categories:
Acupressure is a subsection of complementary and alternative medicine that originated in ancient China. It shares the same principles as acupuncture. Both practices are based on the activation of acupoints along meridians to balance the flow of energy, known as Qi, in the body. 7 Achieving the De-qi is crucial for the success of acupressure or acupuncture treatment and their clinical efficacy. When acupoints are properly activated, patients will experience De-qi. De-qi is a sensation felt during treatments, often described as a dull ache, heaviness, or tingling at the acupoint site, or an electric shock-like sensation through the body.8,9 Ease of learning, cost-effectiveness, and being needle-free are some of the advantages of acupressure compared to acupuncture. 10 Acupressure is a needle-free, hand-mediated, and noninvasive method that promotes healing and enhances the patient’s well-being.
The primary focus of acupressure studies is pain control,11,12 with the LI4 acupoint being one of the most frequently utilized points in this area of research.13–17 A significant portion of these studies focuses on reducing pain associated with injection or needle entry.15,16,18–21 One of the initial studies on reducing pain from local anesthetic injections in pediatric dentistry concluded that acupuncture at the LI4 reduces pain and autonomic distress. 17 However, few studies have explored the effect of acupressure on injection pain in pediatric dentistry. Therefore, the aim of this study was to investigate the effect of acupressure on dental injection pain in children.
METHODS
Trial Design
This study employed a crossover, triple-blind, randomized controlled trial design. Ethical approval was granted by the University Ethics Committee (IR.TUMS.DENTISTRY.REC.1402.016). The study was registered with the Iranian Registry of Clinical Trials under code IRCT20230502058053N1 and received ethical approvals. Informed consent was obtained from the parents or legal guardians of the children, and the children’s assent was also considered prior to the study.
Participants
Participants were selected from 6–12-year-old patients who visited the pediatric dentistry department at Tehran University of Medical Sciences from October to December 2024. Inclusion criteria were as follows:
A score of 1 or 2 according to the American Society of Anesthesiologists (ASA) physical status classification. A score of 3 or 4 according to the Frankl behavior scale. No intake of painkillers or sedatives in the past 12 h. Requirement for either a nerve block or supraperiosteal injection, with the type of injection being the same in two consecutive visits. Previous experience with at least one local anesthetic injection in dentistry. No familiarity with acupressure techniques. Absence of wounds or bruises at the desired acupoint. No need to reinsert the needle into the tissue during injection. No local or systemic infection.
Randomization and Blinding
Randomization was performed using a coin flip, assigning children to one of two groups: one group received acupressure in the first session followed by sham acupressure in the second session, while the other group received sham acupressure in the first session followed by acupressure in the second session.
This study was triple-blind: the children and their parents were unfamiliar with acupressure, the observers were unaware of the type of intervention, and the statistical analysts were also blinded.
Interventions
Acupressure was performed by a single trained individual (qualified by a professor from Beijing University of Chinese Medicine). First, the LI4 (He Gu) point was located on the dorsal surface of the hand, between the first and second metacarpal bones, slightly closer to the second metacarpal (Fig. 1). Our acupressure protocol combined continuous and intermittent methods. First, the acupoint was pressed with the thumb for 2 s, repeated 10 times. Then, continuous pressure was applied for 10 s, with the latter cycle performed at the end. The same process was repeated for the opposing hand. The amount of pressure applied to reach De-qi was adjusted according to each patients’ body size. After acupressure, one postgraduate candidate in pediatric dentistry administered the local anesthesia injection. For all the patients, lidocaine 2% with 1:80,000 epinephrine (EXIR pharmaceutical Co., Iran) was injected with a 27-gauge short needle (Feizteb Co., Iran).

LI4 acupressure point.
In the sham acupressure session, the same acupoint (LI4) was identified, and the same protocol was applied on both hands—2 s of pressure repeated 10 times, followed by 10 s of continuous pressure, with the latter cycle performed at the end. The only difference was the application of light touch on the acupoint without inducing De-qi. Due to the similarity between the two sessions and the patients’ unfamiliarity with acupressure, they were unable to distinguish between real and sham acupressure.
Pain Assessment
Pain levels during injection were assessed using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale by two observers who were blinded to the intervention. In case of disagreements between the observers, they discussed the differences with a third person to reach a consensus. The FLACC scale consists of five parts: facial expression, leg activities, bodily activity, crying, and consolability. Each part of the FLACC scale is scored from 0 to 2, yielding a total score range of 0–10. Higher scores indicate a stronger reaction to pain. Five minutes after the injection, patients were asked about their pain using the Faces Pain Scale-Revised (FPS-R). This scale includes six faces, each scored from 0 to 10 based on pain intensity.
Outcome Measure
Pain assessment during the injection, following both acupressure and sham acupressure, was the primary outcome measure.
Sample Size Calculation
Based on the study by Usichenko et al., 17 using paired means power analysis in the PASS11 software (NCSSS, LLC; USA) with α = 0.05 and β = 0.2, and a standard deviation of 1.6 for the mean difference in pain scores, the minimum required sample size to detect a significant difference of one unit in the pain index is 23 samples. Accounting for a 20% probability of loss to follow-up, the initial study sample size needs to be 28 samples.
Statistical Analysis
Data analysis for this study was performed using IBM SPSS Statistics version 26 (SPSS, Inc.; Chicago, IL). Since the data distribution for both scales was non-normal, the Wilcoxon Signed Ranks Test (WSRT) was used to compare pain levels between the two sessions for both scales. To evaluate and account for the time effect and carry-over effect, the Mann–Whitney test was conducted before the final data analysis. In addition, a sensitivity analysis was performed to evaluate best-case and worst-case scenarios by assigning the most extreme plausible pain scores (minimum and maximum) to the missing data points. A p-value of <0.05 was considered statistically significant.
RESULTS
Figure 2 illustrates the study plan based on crossover flow diagram. Statistical analyses were performed on 24 participants (11 boys, 13 girls) with a mean age of 7.16 ± 1.34 years. All follow-up losses were due to the parents’ reluctance to complete the dental treatment. Table 1 shows descriptive data for each scale and each intervention separately. According to the treatment plan, 14 participants received a supraperiosteal injection, while 10 participants received an inferior alveolar nerve block. No participants sustained any harm as a consequence of this study.

Flow diagram of cross-over design.
Descriptive Data of Pain Scores
FLACC, Faces, Legs, Activity, Cry, Consolability scale; Faces Pain Scale-Revised.
Based on the Mann–Whitney test, there was no significant difference between the total results of the first and second sessions. Consequently, neither the time effect nor the carry-over effect was significant (p = 0.33).
The WSRT showed that acupressure reduced injection pain compared to sham acupressure as assessed by the FLACC scale, although this reduction was not statistically significant (p = 0.14). According to FPS-R, children reported higher pain levels after acupressure, but the difference was not statistically significant (p = 0.72).
Based on the sensitivity analysis, the p-values at the extreme points were 0.108 and 0.092 for FLACC and 0.103 and 0.082 for FPS-R.
DISCUSSION
The aim of this study was to investigate the effect of acupressure at the LI4 point on the pain from local anesthesia injections in children.
The results indicated that acupressure did not significantly reduce injection pain. Although few studies have investigated the effects of acupuncture or acupressure during dental injections, those have generally demonstrated significant pain reduction. The effectiveness of acupressure, in terms of both type and level of response, in comparison to acupuncture, remains unclear. 22 Therefore, caution should be exercised when extrapolating the findings from acupuncture studies to acupressure.19,21 In one study, parents stimulated the needles by massage throughout the dental procedure. 17 This could have distracted children, preventing a proper assessment of the true effects of acupuncture. In this study, we did not perform acupressure during the injection to eliminate any distraction-related effects. Another reason for the difference in our results compared to others is the lack of a uniform protocol regarding acupoint selection, pressure application, and duration of acupressure, as highlighted in Lin’s systematic review. 23
Contrary to our study, where the injection was administered immediately after acupressure, another study performed the dental injection 15 min after completing acupressure and reported significant pain reduction. 24 One reason for the difference in results between our study and Gurharikar’s is that we did not allow for the 15–20 min needed for endogenous peptide release and its associated effects. This process is an effective mechanism through which acupressure exerts its effects.22,25 Moreover, the LI4 is located far from the painful area, which may have prevented immediate pain relief through acupressure. 26 Despite this assumption, some studies have reported that acupressure effectively reduced injection pain even when acupoints were distant from the injection area and there was no waiting period for endogenous peptides release.13,14,26 To examine this hypothesis, further experiments using high-quality study designs are necessary.
In our study, the use of sham acupressure as the comparison group stood out as a key strength, as it played a crucial role in enhancing blinding and ensuring the reliability of our findings. Based on the FPS-R results, pain reports were lower in the sham acupressure group compared with the acupressure group, but this difference was not statistically significant. Other studies have reported that acupressure significantly reduces pain compared to sham acupressure, while also noting a pain-relieving effect of sham acupressure when compared to a control group.15,19 However, unlike these two studies, our research did not include a control group. As a result, pain perception without any intervention was not measured for each child. This lack of baseline measurement could be a reason for the lack of significance in our results, as observed in Bao’s study. 27 Cloquhoun and Novella believe that acupuncture may have only a placebo effect or that its impact is too small and transient to be clinically significant. 28 The need for further research to determine whether acupressure has a placebo effect is evident.
Another key strength of this study lies in its crossover design, which allows for the individual comparison of confounding factors that influence children’s pain perception, such as age, gender, temperament, cognitive abilities, previous experiences, and parental anxiety.29–32 One factor that still remains as a confounder is children’s anxiety during each session. Anxiety and pain influence each other mutually: anxiety can lower pain perception thresholds, while increased pain perception can raise anxiety levels. 33 Furthermore, it appears that anxious patients experience pain for a longer duration. 34 Many studies have reported that acupressure can significantly reduce anxiety level.22,35–38 Future studies are recommended to use a combination of acupoints related to both pain and anxiety to gain better insight into pain perception.
This study was not without limitations. First, we didn’t have a control group without intervention, which necessitated performing three similar injections on each participant. This design required a longer sampling period, which was impractical within the environment of an educational center due to fixed academic schedules and the restricted availability of participants. Second, the number of individuals who received sham acupressure in the first session was not equal to those who received actual acupressure, which may have affected the validity of our results. Third, a key limitation was participant dropout, mainly due to financial constraints. As our study used a crossover design, only participants who completed both phases could be included in the analysis. Nevertheless, these dropouts did not affect the final conclusion, as the sensitivity analysis remained consistent with the primary results. However, they may still introduce selection bias and limit generalizability. Fourth, although potential performance bias was reduced through measures such as recruiting a single operator and implementing a triple-blind design, the different sensory perception among participants due to the nature of the interventions remained inevitable.
Future research should consider strategies, such as participant compensation, to minimize dropout and address missing data more effectively.
CONCLUSION
This study found no significant difference in pain levels between the acupressure and sham acupressure groups. Consequently, acupressure did not demonstrate a reduction in dental injection pain. Furthermore, research in the field of dentistry, exploring various acupoints, is needed to draw conclusive results.
Footnotes
ACKNOWLEDGMENTS
The authors express their gratitude to the professors from the Department of Pediatric Dentistry at TUMS for their valuable collaboration during the sampling and intervention phases of this study.
AUTHOR DISCLOSURE STATEMENT
No competing financial interests exist.
FUNDING INFORMATION
This work was not funded.
AUTHORS’ CONTRIBUTION
H.M.: Conceptualization (lead), investigation (lead), methodology (supporting), project administration (lead), and writing original draft (lead). B.S.: Conceptualization (supporting), investigation (supporting), methodology (supporting), review and editing (equal). M.H.A., Conceptualization (supporting), investigation (supporting), methodology (lead), review and editing (equal). S.G.: Conceptualization (supporting), investigation (supporting), methodology (supporting), project administration (lead), review and editing (equal). All authors read and approved the final version of the article for submission.
CONFIRMATION STATEMENT
Each author confirms that this research was supported by Tehran University of Medical Sciences.
