Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery

NCT04645654 | Completed DMC

• 1 other identifier: CER-VD 2020-01710
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This study will measure the efficacy of hypnosis on pain after a major abdominal surgery. The aim is to further improve comfort and rehabilitation of patients after surgery, beyond the usual early recovery after surgery (ERAS) enhancement protocols. Patients will be randomised (1:2) to the standard of care regarding pain management and rehabilitation, as part of the ERAS protocol, vs. ERAS + an additional hypnosis intervention. In this group, hospitalised patients are given 3 hypnosis sessions targeting analgesia between postoperative day 1 to 12. The study will collect outcomes about pain and its burden, sleep quality, appetite, mobilisation and mood. Secondary outcomes also include use of pain medication and length of hospital stay.

Conditions

Hypnosis; ERAS; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity at mobilisation

  visual analogue pain intensity scale from 0 (no pain) to 10 (most intense pain imaginable)

  Between postoperative day 1 to 12.

Secondary Outcomes (5)

• Pain intensity at rest

  Between postoperative day 1 to 12.

• Pain unpleasantness

  Between postoperative day 1 to 12.

• Opioid consumption

  Between postoperative day 1 to 12

• Post-surgical complications

  Between postoperative day 1 to 12

• Length of hospital stay

  through study completion; records checked up to 100 days after end of study participation

Study Arms (2)

Hypnosis

EXPERIMENTAL

3 sessions of script-based hypnosis (analgesic suggestions) + recordings provided for self-hypnosis

Behavioral: Hypnosis

Standard of care

NO INTERVENTION

Standard of care ERAS based optimized multimodal analgesia, without any complementary medicine

Interventions

Hypnosis BEHAVIORAL

Three sessions of 30 minute hypnosis, based on standardised script, focused on pain management.

Hypnosis

Eligibility Criteria

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

You may qualify if:

• Female and male adults (from 18 years old).
• Major abdominal surgery with planned hospitalisation of more than seven days post-operatively, according to clinician's evaluation
• Able to give informed consent as documented by signature
• Interested in trying hypnosis as a complementary pain management therapy

You may not qualify if:

• Inability to engage in the intervention of the study, e.g. inability to communicate in French without a translator, cognitive impairment, severe hearing impairment
• Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Centre de Médecine Intégrative et Complémentaire, CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chantal Berna, Prof

  Centre de médecine intégrative et complémentaire, CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 27, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: November 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)