Self Regulation Hypnotic Intervention for Pain and Anxiety During Rectal Brachytherapy

Research question and Specific Aims:Primary objectives of this pilot Randomized Controlled Trial are to evaluate the effectsof SRHI with colorectal cancer patients receiving brachytherapy on: 1) self‐reported painand anxiety levels (measured with a self‐report numeric rating scale and facial painexpression) 2) frequency and total doses of administered analgesics and sedatives,procedural length and difficulty and 3) fluctuations of vital signs (heart rate,respiratory rate, pulse oximetry and blood pressure). Ancillary measures will also betaken in order to fuel several future research projects. These include measures ofanxiety, depression, personality, quality of life, self‐efficacy, and brachytherapyoutcome. Since the brachytherapy procedure is new and treats the most prevalent cancer,knowing if hypnosis can be used to ease the experience of patients is important.Unfortunately, research on this subject is scarce.Study Design:Patients deemed eligible for brachytherapy will meet the research assistant (RA) who willexplain research consent form and proceed with Mini Mental State Examination. If allinclusion criteria are met, the RA will hand out a package of self‐report questionnaires.All participants will be given an appointment for the hypnotizability measure.Participants will all be told that they responded well to the instructions but they willremain blind to their hypnotizability score/performance. Self‐report questionnaires andhypnotizability measures must be completed before first brachytherapy session.Eligible participants who are thought to need in‐procedure pain and anxiety managementwill be randomized to a) those who will get the SRHI and b) those who will not (controlgroup). All participants will be told that they would have access to as much medicationas they want within safe limits.Hence, we will have a total of two groups: I) the experimental group, participants whoreceive SRHI and II) participants who will act as the group control for the experimentalgroup and will not receive the SRHI. All participants assigned to the experimental groupwill meet a psychologist duly trained in clinical hypnosis once for training and will becontinually assisted during the intervention (see Intervention section).Hypnotisability measure will be verified by an inter‐rater reliability measure.Twenty‐five percent (25%) of the administrations will be scored by an independent coder.For the patients in the standard procedure and those in the control group, the medicalstaff will be instructed to behave naturally the same way they usually do during theprocedure in terms of comforting the patient, but to refrain from giving imageryrelaxation and hypnotic inductions.Participants of both groups will be administered pharmacological assistance to managepain and anxiety if they ask for it. All participants will be free to withdraw from thestudy at any time. The staff will keep track of dosage, type of medication administeredand procedural time of administration. The pain and anxiety will be assessed just beforethe beginning of the procedure, at the insertion of the applicator and every 15 minutesduring the procedure. Pain and anxiety levels will also be noted each time the patientsask medication. To ensure that the study is secure and ethic, usual medical interventionswill be performed by the chief radio‐oncologist if any adverse event occurs.Self Regulation Hypnotic Intervention:The intervention will consist of a modification of a hypnotic relaxation script tailoredto fit the unique characteristics of rectal brachytherapy and patients' experience ofanxiety, pain intensity and unpleasantness. An experienced psychologist will direct a 40minutes individual session providing hypnotic analgesia intervention before thebrachytherapy procedure. A 10 minutes rehearsal will be done each day prior treatment.Furthermore, the psychologist will deliver the hypnotic intervention during each of thefour treatment days. The hypnotic intervention will follow the clinical features (i.e.insertion of the applicator) of the procedure as cued by the treating physician.