Self Regulation Hypnotic Intervention for Pain and Anxiety During Rectal Brachytherapy

NCT07619768 | Completed DMC

• 1 other identifier: SRHI rectal brachy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• Pain and Anxiety Self Report

  Participant's self-reports of pain and anxiety will be obtained through the use of verbal Numeric Rating Scales (NRS) from 0 (no pain, no anxiety) to 10 (worst possible pain, worst possible anxiety). These scales are currently implemented at the Jewish General Hospital (JGH) , and the NRS for pain is recommended for use in clinical trials and in clinical guidelines for cancer-related pain .

  Perioperative/Periprocedural

• Vital Signs

  Vital signs will be continuously recorded with a data collection computer (Moberg Research Inc., USA) connected to the patient's portable monitor (Philips Intellivue MP50) in the brachytherapy room using a serial-port cable, and specific events (i.e., before, during, and after brachytherapy) will be marked. Means of all vital signs will be calculated for one-minute duration at specific times as described in the procedure section.

  Perioperative/Periprocedural

• Facial expressions of pain checklist

  Facial expressions of pain will be video recorded during brachytherapy using a behavioral checklist developed by one of the coinvestigator (Céline Gélinas). This checklist is a combination of two previously validated behavioral pain assessment tools i.e. the Pain Behavior Assessment Tool (PBAT;) and the Critical-Care Pain Observation Tool. The Facial Expression section includes 16 dichotomized items (yes/no).

  Perioperative/Periprocedural

Secondary Outcomes (9)

• The Hypnotizability Induction Profile

  At recruitment

• The Short Form 36 Health Survey Questionnaire (SF-36)

  Change from Before brachytherapy treatment to one month after surgery

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 and the supplemental for Colorectal 29 (EORTC-QLQ-C30 & EORTC-QLQ-CR29)

  Change from Before brachytherapy treatment to one month after surgery

• The Patient Health Questionnaire 9 scale (PHQ-9)

  Change from Before brachytherapy treatment to one month after surgery

• The Generalised Anxiety Disorder 7 scale (GAD-7)

  Change from Before brachytherapy treatment to one month after surgery

Study Arms (2)

Self-Regulation Hypnotic intervention

EXPERIMENTAL

The participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, the psychologist (experienced in clinical hypnosis) teaches patients how to use self-hypnosis during 40 minutes prior to treatment, and guides them throughout their treatment.

Behavioral: Self-Regulation hypnosis

Treatment As Usual

NO INTERVENTION

The participants meet a psychologist and a research assistant for about 15 minutes to learn information about the study and hypnosis. Once the consent is signed, their hypnotizability level and general mental state is assessed. After that, participants go on to their treatment with no additional intervention, but a research assistant collects data throughout their treatment.

Interventions

Self-Regulation hypnosis BEHAVIORAL

A psychologist specialised in clinical hypnosis teaches patients to use self-hypnosis and guides them through their treatment

Self-Regulation Hypnotic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score over 25 on the MMSE,
• Fluent in english or french elected for brachytherapy treatment for rectal cancer

You may not qualify if:

• Medication for pain, anxiety or depression on a non-regular basis.
• Organic brain condition

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Radio-Oncology

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Te Vuong, MD

  Sir Mortimer B. Davis - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radio-Oncologist

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: June 2, 2026
• Study Start: July 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: June 2, 2026

Record last verified: 2016-04

Locations

CA (1)