Abstract
Objective:
To assess the effectiveness of hypnosis to reduce pain and facilitate external cephalic version (ECV).
Design:
Cohort study.
Setting:
Geneva University Hospitals, Switzerland.
Participants:
63 women attempting ECV under hypnosis from 2010 to 2011 were compared with 122 women who received standard care from 2005 through 2008.
Intervention:
Immediately after the ECV attempt, both groups completed the same questionnaire evaluating the participants' pain (visual analogue and verbal rating scales) and experience with the procedure. Physicians also completed a questionnaire that elicited their views on the effect of hypnosis on the intervention. A chi-squared test was used to compare differences in proportions, and the Mann-Whitney U test was used for differences in continuous variables. A thematic content analysis of the obstetricians' responses to the open question regarding their experience of hypnotist accompaniment was also performed.
Outcome Measures:
Pain evaluated by women (visual analogue and verbal rating scales) and success rate of ECV.
Results:
Pain intensity reported by women did not significantly differ between the hypnosis group and the standard care group (visual analogue scale score, 6.0 versus 6.3, respectively; p=.25; difference for verbal rating scale, p=0.31. In 72% of cases, physicians reported that hypnosis facilitated the procedure. The success rates in both groups were not significantly different (30% with hypnosis compared with 38% without; p=.31). Most women in both groups found the ECV attempt painful and a source of anxiety but would undergo it again if necessary.
Conclusion:
Hypnosis accompaniment during ECV does not reduce pain intensity associated with the procedure or improve the probability of a successful version.
Introduction
Even in hospitals where vaginal breech delivery is performed, most women choose to give birth by cesarean delivery. 3 An alternative option is to attempt external cephalic version (ECV). This procedure carries minimal risk for the fetus and the mother if performed in a safe environment. 4 The success rate varies from 30% to 70%, depending on clinical factors. 5 A previous study conducted at the Geneva University Hospitals, Geneva, Switzerland, reported that approximately 25% of patients declined this intervention because of fear of fetal distress or pain. 6 The authors also reported that most women found ECV to be painful. Several techniques for repositioning the fetus, including moxibustion or maternal posture, have been evaluated, but none has been shown to be effective. 7,8
Because ECV is the only effective method, it is important to assess techniques to reduce pain intensity and improve the experience of women during this intervention.
Hypnosis is a state of consciousness in which the subject's attention is concentrated and focused. This hypnotic state, called a trance, is characterized by an increased responsiveness to all verbal messages, referred to as suggestions. These suggestions allow achieving certain therapeutic benefits, such as relief of pain or anxiety. 9 –11 Several studies have reported encouraging results with hypnosis for surgical pain relief, but, to our knowledge, no studies have evaluated hypnosis during ECV. 12, 13 The main objective of this study was to evaluate the effects of hypnosis on pain intensity during ECV and on ECV success rate. The secondary objectives were to evaluate the women's views of ECV and obstetricians' views of hypnosis for the efficacy of ECV.
Materials and Methods
We performed a cohort study at the maternity unit of the Geneva University Hospitals, Geneva, Switzerland, to compare two groups of women attempting ECV with standard care or under hypnosis. The standard care group included women for whom ECV was attempted from 2005 through 2008 and who completed a questionnaire evaluating pain and their views on the procedure. 8 These women were a subgroup of participants in a randomized controlled trial on moxibustion, previously conducted on our obstetrics service. ECV was proposed because of persisting breech presentation at 37 weeks' gestation. The hypnosis group was prospectively enrolled between 2010 and 2011 and consisted of all women for whom ECV was attempted during this period and who agreed to be accompanied by a hypnotist.
Inclusion criteria were singleton pregnant women with a fetus in a breech presentation who wanted to attempt ECV. Exclusion criteria were contraindications to ECV, age younger than 18 years, and no understanding of French language. In the hypnosis group, women with hearing loss and contraindications to hypnotic trance (i.e., psychiatric disorders, such as psychosis, paranoia, or borderline personality) were excluded. In both groups, study inclusion was finalized on the day of the ECV attempt after confirmation of breech presentation by ultrasound. The eligibility criteria for ECV and the medical procedure (including intravenous tocolytic administration during ECV) were not modified between the periods when the standard care and the hypnosis groups were included.
Intervention
Women in the standard care group were managed by the obstetric team in charge of the delivery room. The obstetrician performed the procedure, and the midwife provided emotional support to the patient with verbal (encouragement, reassurance) and nonverbal (hand and eye contact) techniques. Women in the hypnosis group were managed by the same obstetric team. Hypnosis was performed by one of four trained hypnotists involved in the study (two midwives, a nurse anesthetist, and an anesthesiologist). Sessions were performed randomly by one of the hypnotists, according to their availability, on the day scheduled for the ECV. The first contact between the patient and the hypnotist occurred shortly after the patient arrived in the delivery room on the day of the ECV attempt. Women were asked to choose between two options: (1) choosing a safe place (i.e., a place or an instance of safety and well-being, or a memory or a projection of a location where she would feel comfortable at this time) or (2) using suggestions based on current sensations. The hypnotist decided on the type of hypnotic induction to be used to establish the trance state, such as focusing on a specific item (e.g., the patient's own breathing). The woman was then brought to her safe place, which was stimulated using details provided before the induction of the trance, or was asked to focus on her current sensations. This accompaniment continued throughout the intervention and ended with the success of the procedure or the decision not to continue. Verbal communication or a predetermined sign was used to make sure that the woman's experience was bearable. The exit of the trance state was gradual, by countdown or other means. Hypnosis accompaniment was performed to avoid any interference with the usual ECV procedure as much as possible.
Women in both groups completed the same questionnaire within 2 hours of the ECV attempt. The questionnaire assessed pain by using a visual analogue scale (VAS) ranging from 0 (no pain) to 10 (the worst possible pain) and a verbal rating scale (VRS) that included six qualifiers of the intensity of perceived pain (absent, low, uncomfortable, strong, severe, and excruciating). In addition, women were asked to respond to four statements according to a Likert scale (strongly agree, agree, neutral, disagree, strongly disagree). The questionnaire was distributed after the departure of both the hypnotist and the obstetrician so as not to influence the responses. Questionnaires were collected by a research assistant.
A short questionnaire was given to obstetricians performing ECV in the hypnosis group. This evaluation instrument was added after the start of the study when 10 women were already included. The obstetricians were asked whether the accompaniment by the hypnotist had helped, not interfered with, or hindered patient management. A space was reserved for comments.
Sample size
We had previously collected data on 122 women who had standard care during ECV. The sample size of the hypnosis group was based on the ability to show a minimum difference between groups of half a standard deviation of the distribution, which corresponded to approximately 1 cm on the VAS. With a significance level of .05 and a power of 90%, it was calculated that at least 63 women (a ratio of approximately 1:2) would need to be included in the study.
Statistical analysis
Quantitative data analysis was performed. The chi-square test was used to compare differences in proportions, and the Mann-Whitney U test was used for differences in continuous variables. We dichotomized the data reported on the VAS into two groups: scores of ≤5 and >5. We adjusted the risk for severe pain for potential confounders (i.e., success or failure of ECV and parity) with logistic regression analysis. The significance level was set at p<.05, and 95% confidence intervals were reported. We also performed a thematic content analysis of the obstetricians' responses to the open question regarding their experience of hypnotist accompaniment during ECV. 14 All analyses were performed by using SPSS software, version 20 (IBM Corp., Armonk, NY).
Details of ethics approval
The study received ethical approval from the Geneva University Hospitals' ethics committee (CER 09-051). All women gave signed informed consent before being enrolled in the study.
Results
During the first period, 122 women attempted ECV (standard care group). Of the 172 women eligible to participate in the hypnosis group during the second period, 106 were informed of the study, depending on the availability of research assistants; 21 declined to participate, and 22 could not be included for organizational reasons, such as absence of a hypnotist the day of ECV. Thus, a total of 63 women were included. Baseline characteristics were similar between groups (Table 1). There was a trend toward more primiparous women in the standard care group than in the hypnosis group (73% versus 62%, respectively; p=.09), but the differences were not statistically significant.
Values expressed with a plus/minus sign are the mean±standard deviation. ECV, external cephalic version.
No statistically significant difference was observed between the hypnosis and standard care groups for pain intensity, as reported on the VAS (median VAS, 6.0 versus 6.3, respectively; p=.25) or in responses to the VRS (Table 2). Among the standard care group, 30% of women described the pain as unbearable compared with 24% of the hypnosis group (p=.31). The only variable that had a significant effect on pain perception was the success or failure of the ECV attempt (VAS score, 5.1 vs. 6.3, respectively; p=.004). We adjusted the relative risk of reporting pain intensity >5 on the VAS for ECV success. The unadjusted relative risk was 0.91, and the adjusted relative risk was 0.89. When the analysis was stratified for parity, no difference was observed between the unadjusted and adjusted relative risks (both 0.91). The results were similar to the unadjusted measures.
Values expressed with a plus/minus sign are the mean±standard deviation. SDIQ, standard deviation interquartile range; VAS, visual analogue scale; VRS, verbal rating scale.
More than 70% of the women would advise a friend with breech presentation to undergo an ECV attempt and would undergo it again themselves if necessary. However, the same proportion of women found the procedure to be distressing. Both groups provided similar answers (Table 2). In 72% of cases, the obstetricians who attempted ECV on women under hypnosis considered that this management had facilitated the procedure by improving maternal collaboration and relaxation of the abdominal wall. Table 3 provides excerpts from a thematic analysis of open questions to physicians.
This evaluation included only 53 procedures.
Discussion
This study demonstrated no effectiveness of hypnosis for pain relief during an ECV attempt or success rate of ECV. At our institution, we refrain from using epidural or other major analgesia during ECV because it may mask excessive pressure applied during the procedure that may harm the fetus. Several literature reviews on the effectiveness of alternative medicines for pain relief in obstetric care have suggested the positive effect of hypnosis. All studies evaluated hypnosis used in addition to drug analgesia or administered to reduce the demand for such drugs. 15,16 To our knowledge, this is the first study to evaluate the potential benefits of hypnosis as the sole analgesic method.
Although a randomized clinical trial would be the best study design to assess this type of intervention, conducting a study to evaluate hypnosis to reduce pain during ECV could have resulted in a strong bias. As in any trial, consenting women are those interested in having the intervention. 17 For this reason, we consider that a woman's disappointment at being randomly assigned to the standard care group could have influenced the primary outcome of the study. 18 Pain perception and women's views of the procedure are highly subjective and complex. The origin, circumstances of occurrence, and circumstances of measurement of pain can influence its perception, as well as the meaning that the woman might attribute to pain, associated emotions, and social support. 19 We hypothesize that disappointment over inclusion in the control group could have increased reported pain or negative views, thus overestimating the effect of the intervention. Therefore, we preferred to compare a previous ECV group that received standard care with a prospectively enrolled group with hypnosis accompaniment, using the same questionnaire for both groups.
We used the VAS and VRS to measure pain intensity. These are standardized tools, and their reliability has been demonstrated. Nevertheless, the effect of hypnosis on pain perception could depend on affective and sensory components rather than the sensitive component. If this is true, a more qualitative exploration of pain might have provided different elements of understanding. For example, the McGill Pain Questionnaire 19 is a tool for assessing this emotional component, but it is designed to assess chronic rather than acute pain, such as that experienced during ECV. We report the analysis of women's experiences during ECV and demonstrate that the success of the intervention significantly reduced the reported pain. 6 We found the same association in the hypnosis group. This variable was not a confounding factor on the effect of hypnosis on pain perception because the crude estimated relative risk is similar to the adjusted relative risk. Ideally, pain perception should be assessed during the procedure, before success or failure is known, but performing such an assessment during ECV would be impossible, especially during hypnosis.
The team of hypnotists chose not to perform a preparation session before the day of the procedure on the basis of their experience and the study by Meyer. 20 Similarly, we did not assess the participants' ability to be hypnotized before inclusion in the study. Under experimental conditions, Milling and colleagues suggested that hypnotizability could be a useful predictor of effectiveness. 21 However, in a previous study on which we based the development of the protocol used here, the research team reported that these tests were not useful. 22 Moreover, Erikson believes that every individual is hypnotizable and that the hypnotic trance is a natural state of consciousness experienced. 11 Further studies are required to increase the knowledge on the optimal practice of hypnosis for pregnant women.
It has been shown that the psychological management of patients is a major role of caregivers. Such care can independently influence how the patient views the procedure and, indirectly, pain perception. 23 In our study, we observed a pain relief effect similar to that of hypnosis through the standard care dispensed by the midwives. The effects of this type of accompaniment, similar to the concept of “tender, loving care,” may in itself be considered an intervention. 24
Although practitioners have identified a good relationship with the obstetrician and a particular state of relaxation, notably abdominal wall relaxation, in most ECV attempts under hypnosis, the success rate of ECV did not improve in our study. Despite the pain and anxiety reported, most participants would undergo an ECV attempt again for breech presentation and would recommend this procedure to friends. This outcome might be explained by the strong motivation of women to use techniques that promote fetus version, related to their desire to increase their chances of giving birth vaginally.
Conclusion
We did not observe any benefit from hypnosis in reducing the pain intensity or anxiety experienced by women undergoing an ECV attempt or in increasing the success rate of the procedure. Further studies are needed to investigate other techniques aimed at relieving pain during this procedure without compromising efficacy or safety.
Footnotes
Acknowledgments
The authors thank the University of Applied Sciences of Western Switzerland and the Department of Gynaecology and Obstetrics of the Geneva University Hospitals, Switzerland, for financial assistance. We thank all participants and also the following, all from the Department of Gynaecology and Obstetrics of the Geneva University Hospitals, Switzerland, for their active participation in the study: L. Rochaix, P. Moresi, and F. Maiza Mallet, hypnotists; Dr. I. Romoscanu, medical doctor; C. Citherlet, midwife coordinator; R. Azbar Swali and V. Othenin-Girard, research assistants; and M. Tellenbach, data manager.
This study was supported by the University of Applied Sciences of Western Switzerland, Geneva, Switzerland, and the Department of Gynaecology and Obstetrics of the Geneva University Hospitals, Geneva, Switzerland. Some of the data analyzed in this study were collected as part of a previous study funded by the Swiss National Science Foundation (SNFS, DORE research grants). 8
Disclosure Statement
No competing financial interests exist.
