Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery

Postoperative Pain Clinical Trial

— Hypn+ERAS  

Official title:

A Randomized-controlled Clinical Trial of Brief Postoperative Hypnosis Intervention as Multimodal Analgesia After Major Abdominal Surgery in the ERAS Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645654
• Other study ID #: CER-VD 2020-01710
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 1, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ERAS
• Hypnosis
• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• Hypnosis
Three sessions of 30 minute hypnosis, based on standardised script, focused on pain management.

Locations

Country	Name	City	State
Switzerland	Centre de Médecine Intégrative et Complémentaire, CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

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