Participants
The study participants were a sample of volunteers attending the 7th congress on "Hypnosis and Pain" organized by the French “Émergences” teaching institute, that happened in Saint-Malo, France, in May 2022. The study was initially scheduled for May 2020, but the congress was canceled and postponed two years later because of the COVID pandemics. Participants were informed during the congress opening conference that they could participate in this study by registering to scheduled hypnosis scientific workshops. After oral explanation of the study and written informed consent was obtained, all the subjects registered to the workshops were included. The inclusion criteria for the study included the following: aged eighteen years or older, with or without prior experience in hypnosis as a subject, with decisional capacity to consent to the study, able to communicate verbally, who had given their consent according to the methods described in article L1122-1-1 of the French Public Health Code, and affiliated to a social security scheme or benefiting from such a scheme. The exclusion criteria were people with a visible inability to communicate in French, or with a history of cardiac arrhythmias. The latter was justified using live cardiac monitoring, the results of which could be disrupted by the presence of an arrhythmia. There were no other exclusion criteria. The study was approved by our institutional review board and registered on ClinicalTrials.gov (NCT05306262) in 2022 before enrolling subjects.
All hypnosis sessions were initially planned to be performed by experienced trainers from the organizing teaching institute, who registered at different slots of the scientific congress, so that they could still enjoy all the other scientific presentations and workshops. Their professions were either physicians (mostly anesthesiologists and psychiatrists) or other healthcare providers (nurses, anesthetic nurses, and psychologists), all trained in medical hypnosis for more than five years. Because some teachers did not all come at their allotted slots, some unexpected professionals were asked to participate in the protocol as hypnosis facilitators. This was easily done because the study protocol was quite simple to perform.
Before randomization, ANI electrodes were placed on the subject’s chest to record the parasympathetic activity throughout the entire experiment. Briefly, ANI is a 0-100 index derived from heart rate variability reflecting the relative parasympathetic tone, with values of fifty and higher corresponding to prominent parasympathetic tone, therefore higher patient comfort [2–4]. A portable pulse oximeter was placed on one finger of each participant using the hand opposite to catalepsy (if any) to record the heart rate (HR) during the experiment. An observer not involved in the hypnotic session assessed the respiratory rate (RR) during the experiment and recorded all measures (ANI, HR, RR) as described further.
Randomization
All participants were randomized in two arms, all receiving a fifteen-minute positive hypnotic trance, with or without hand catalepsy. The randomization process was prepared in advance with sealed consecutive envelopes. When participants joined the study, an envelope was opened, and the arm of randomization was only shown to the hypnosis facilitators. However, because of the informed consent, it was impossible to blind the participants, or the third person conducting the measures. Therefore, this study was open label. For this reason, we wanted to include both subjective and objective assessments.
Measures
At different times of the study protocol, evaluators registered on a paper form the level of ANI, the respiratory rate, the heart rate. They were also asked to time the different moments of their measures since the beginning of the hypnotic induction. At the end of the hypnotic trance, participants subjectively rated their level of absorption and dissociation, and how long they thought the hypnotic trance lasted.
Intervention
The research hypothesis was that, by adding a body dissociation, catalepsy could facilitate and intensify the hypnotic trance, the intensity of which can be monitored and would be proportional to the parasympathetic tone. After randomization, subjects did either benefit from the usual positive hypnotic trance, or from the same hypnotic trance protocol associated with a hand catalepsy. Right after setting up ANI and pulse monitoring (T0), the subjects, who were in a sitting position, were asked about a place or activity that they usually enjoy visiting or practicing. This would serve as the basis for the positive hypnotic fifteen-minute trance. Right after that, the trance was induced and the subjects were asked to close their eyes (T1), another measure was done. Afterwards, the subjects received positive, relaxing, soothing suggestions, linked to the imagined activity that they chose. This period lasted between five to ten minutes. When the subject could report some comfort using a predetermined signal (putting a thumb up or nodding the head), another measure was done (T2), and then the subjects were progressively awakened from the hypnotic trance and another measure was done (T3). Subjects were then asked to subjectively rate their experience on a 0 (none) to 10 (maximal) scale of feeling of absorption and dissociation, then they were asked to subjectively assess the duration of the hypnotic trance in minutes from eye closure to eye opening [5]. Right after that, a final measure was done (T4). The actual duration of hypnosis from eye closing to opening was also recorded in minutes.
Statistical analysis
Based on our previous study showing a mean ± SD ANI value of 84 ± 12 during the hypnotic trance and estimating a 10% increase in ANI using catalepsy (corresponding to a mean ± SD ANI value of 92 ± 12), a total number of eighty subjects (forty in each group) was calculated in order to assess this difference using a unilateral t test with 𝛼=5% and 90% power (PASS® 11, NCSS, LLC. Kaysville, Utah, USA) [2]. Continuous variables were compared using Mann-Whitney’s U-test or Student’s t-test according to data distribution assessed using Shapiro-Wilk’s test and categorical variables were compared using 𝝌2 test. Variation of data during the different time-points were compared between groups using ANOVA for repeated measures. Continuous data are presented as mean ± SD or median [Q1-Q3] and qualitative data as n (%). All analyses were performed using JASP software version 0.17.3 (JASP Team 2023, open source).