Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial

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.