Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery (Hypn+ERAS)

• ClinicalTrials.gov Identifier: NCT04645654
• Recruitment Status: Completed
• First Posted: November 27, 2020
• Last Update Posted: December 21, 2023
• Sponsor: University of Lausanne Hospitals
• Information provided by (Responsible Party): Chantal Berna, University of Lausanne Hospitals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypnosis; ERAS; Postoperative Pain	Behavioral: Hypnosis	Not Applicable

Detailed Description:

The primary objective of the present study is to evaluate the efficacy of hypnosis as an adjunct to the standard of care pain management program on postoperative pain compared to the standard ERAS program. Our hypothesis is that hypnosis, as part of a multi-modal analgesic management plan, will lead to decreased levels of pain compared to standard of care.

A secondary hypothesis is that better controlled pain will lead to enhanced recovery, in terms of post-operative incidence of complications, physical comfort and independence, psychological and emotional state and length of stay.

This study is an open label randomized controlled trial with two arms, comparing hypnosis as adjunctive therapy vs. standard of care. It is a monocentric study and will take place at Centre Hospitalier Universitaire Vaudois (CHUV), a teaching hospital in Lausanne, Switzerland. It represents a collaboration between the Service of Visceral Surgery and the Center of Integrative and Complementary Medicine.

Participants will be recruited before a planned surgery, as well as in the post-surgical setting. They will be screened by the study team to ensure they fulfil the inclusion criteria. If eligible and after informed consent is obtained, an assessment of the cognitive function will be performed (cf. Chapter 4: study population). All included participants will then be randomized in a 2:1 proportion to the "Hypnosis (H)" group or the "Standard of Care (SOC)" group.

After major abdominal surgery, all participants will benefit from a standard ERAS recovery program. The ERAS protocol involves multimodal pain management with medications, interventional pain therapy as needed, and psychological support if needed.

Relevance:

Acute pain has a major impact on LOS after surgery due to delayed recovery and opioid side effects. Furthermore, acute pain represents a risk for chronic pain, with its massive impact on quality of life and function. Interest is growing for non-pharmacological interventions as part of a multimodal approach for acute pain management. Hypnosis could be a low risk, cost-effective complementary therapy to improve patients' pain management, with possible impact on recovery and eventually a reduction of the length of hospital stay after surgery. If hypnosis is demonstrated to be an effective way to improve post-operative pain management in fragile patients undergoing massive abdominal surgery, then this therapy could be offered more broadly as adjunction to the actual standard of care in our teaching hospital.

Furthermore, the Department of Visceral Surgery at CHUV is a teaching ward, accredited by the ERAS society. Therefore, results may be used to improve patient care within the ERAS society more broadly.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized-controlled Clinical Trial of Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery in the ERAS Protocol
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: September 30, 2023
• Actual Study Completion Date: November 1, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Hypnosis; 3 sessions of script-based hypnosis (analgesic suggestions) + recordings provided for self-hypnosis	Behavioral: Hypnosis; Three sessions of 30 minute hypnosis, based on standardised script, focused on pain management.
No Intervention: Standard of care; Standard of care ERAS based optimized multimodal analgesia, without any complementary medicine

Outcome Measures

Primary Outcome Measures :

1. Pain intensity at mobilisation [ Time Frame: Between postoperative day 1 to 12. ]
   visual analogue pain intensity scale from 0 (no pain) to 10 (most intense pain imaginable)

Secondary Outcome Measures :

1. Pain intensity at rest [ Time Frame: Between postoperative day 1 to 12. ]
   visual analogue pain scale from 0 (no pain) to 10 (most intense pain imaginable)
2. Pain unpleasantness [ Time Frame: Between postoperative day 1 to 12. ]
   visual analogue scale from 0 (not unpleasant) to 10 (most unpleasant pain imaginable)
3. Opioid consumption [ Time Frame: Between postoperative day 1 to 12 ]
   opioid name and dose (mg) recorded in medical chart
4. Post-surgical complications [ Time Frame: Between postoperative day 1 to 12 ]
   list of complications recorded in patient's medical chart
5. Length of hospital stay [ Time Frame: through study completion; records checked up to 100 days after end of study participation ]
   date of entry to date of release from the hospital

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Switzerland

Centre de Médecine Intégrative et Complémentaire, CHUV

Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

• Principal Investigator: Chantal Berna, Prof; Centre de médecine intégrative et complémentaire, CHUV

More Information

• Responsible Party: Chantal Berna, Professor, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT04645654
• Other Study ID Numbers: CER-VD 2020-01710
• First Posted: November 27, 2020
• Last Update Posted: December 21, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations