Clinical trial · Interventional
Self Regulation Hypnotic Intervention for Pain and Anxiety During Rectal Brachytherapy
Self-Regulation Hypnotic Intervention for Pain and Anxiety During Brachytherapy for Rectal Cancer: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-Regulation hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Self-Regulation Hypnotic intervention
- description
- 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.
- interventionNames
- Behavioral: Self-Regulation hypnosis
- type
- NO_INTERVENTION
- label
- Treatment As Usual
- description
- 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.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Score over 25 on the MMSE, * Fluent in english or french elected for brachytherapy treatment for rectal cancer Exclusion Criteria: * Medication for pain, anxiety or depression on a non-regular basis. * Organic brain condition
References
Publications (0)
Data not yet available