Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation

NCT02216539 | Terminated DMC

• 1 other identifier: 2014-A00538-39
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain. The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.

Conditions

Lung Diseases

Keywords

All terminal; leading; indication; lung transplantation

Outcome Measures

Primary Outcomes (1)

• Average Pain Score (Visual Analog Scale) One Month After Surgery

  Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery

  one month after transplantation

Study Arms (2)

Self-hypnosis

EXPERIMENTAL

Patients trained to self-hypnosis before surgery

Behavioral: Self-hypnosis; Procedure: Lung transplantation; Other: Standard post-operative pain management

Usual pain management

ACTIVE COMPARATOR

Patients receiving the usual post-operative pain management protocols

Procedure: Lung transplantation; Other: Standard post-operative pain management

Interventions

Self-hypnosis BEHAVIORAL

Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery

Self-hypnosis

Lung transplantation PROCEDURE

Self-hypnosis; Usual pain management

Standard post-operative pain management OTHER

Post-operative pain management treatments as per usual protocols in the hospital

Self-hypnosis; Usual pain management

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients over 15 years of age
• indication of lung transplantation

You may not qualify if:

• patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Hypnosis; Lung Transplantation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Mireille Michel-Cherqui, MD

  Hôpital Foch, Suresnes, France

  PRINCIPAL INVESTIGATOR

• Marc Fischler, MD

  Hôpital Foch, Suresnes, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

FR (1)