Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial
Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial
The goal of this study is to compare a Self-Regulation Hypnotic Intervention (SRHI) to the standard procedure (Treatment As Usual with analgesic and sedative agents) for pain and anxiety management during rectal cancer brachytherapy. Hypnotizability of patients undergoing this procedure will be assessed and those who are thought to need analgesic and sedative agents during the procedure will be distributed (sequentially adjusted randomization) in two groups, one that will be trained and assisted using hypnosis and one that will not. Procedural pain, anxiety, difficulty and patients' vital sign will be assessed. Our hypothesis is that patients in the hypnosis group will experience less pain and anxiety and will need less medication than those in the control group.
Research question and Specific Aims:
Primary objectives of this pilot Randomized Controlled Trial are to evaluate the effects of SRHI with colorectal cancer patients receiving brachytherapy on: 1) self-reported pain and anxiety levels (measured with a self-report numeric rating scale and facial pain expression) 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 be taken in order to fuel several future research projects. These include measures of anxiety, depression, personality, quality of life, self-efficacy, and brachytherapy outcome. 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 will explain research consent form and proceed with Mini Mental State Examination. If all inclusion 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 will remain blind to their hypnotizability score/performance. Self-report questionnaires and hypnotizability measures must be completed before first brachytherapy session.
Eligible participants who are thought to need in-procedure pain and anxiety management will be randomized to a) those who will get the SRHI and b) those who will not (control group). All participants will be told that they would have access to as much medication as they want within safe limits.
Hence, we will have a total of two groups: I) the experimental group, participants who receive SRHI and II) participants who will act as the group control for the experimental group and will not receive the SRHI. All participants assigned to the experimental group will meet a psychologist duly trained in clinical hypnosis once for training and will be continually 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 medical staff will be instructed to behave naturally the same way they usually do during the procedure in terms of comforting the patient, but to refrain from giving imagery relaxation and hypnotic inductions.
Participants of both groups will be administered pharmacological assistance to manage pain and anxiety if they ask for it. All participants will be free to withdraw from the study at any time. The staff will keep track of dosage, type of medication administered and procedural time of administration. The pain and anxiety will be assessed just before the beginning of the procedure, at the insertion of the applicator and every 15 minutes during the procedure. Pain and anxiety levels will also be noted each time the patients ask medication. To ensure that the study is secure and ethic, usual medical interventions will 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 tailored to fit the unique characteristics of rectal brachytherapy and patients' experience of anxiety, pain intensity and unpleasantness. An experienced psychologist will direct a 40 minutes individual session providing hypnotic analgesia intervention before the brachytherapy procedure. A 10 minutes rehearsal will be done each day prior treatment. Furthermore, the psychologist will deliver the hypnotic intervention during each of the four 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.
Inclusion Criteria:
Score over 25 on the MMSE,
Exclusion Criteria: