Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation (AUTOHYPNOSE-TP)

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.

Study Overview

• Status: Terminated
• Conditions: Lung Diseases
• Intervention / Treatment: Behavioral: Self-hypnosis; Procedure: Lung transplantation; Other: Standard post-operative pain management

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-hypnosis; Patients trained to self-hypnosis before surgery	Behavioral: Self-hypnosis; 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; Procedure: Lung transplantation; Other: Standard post-operative pain management; Post-operative pain management treatments as per usual protocols in the hospital
Active Comparator: Usual pain management; Patients receiving the usual post-operative pain management protocols	Procedure: Lung transplantation; Other: Standard post-operative pain management; Post-operative pain management treatments as per usual protocols in the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Mireille Michel-Cherqui, MD, Hôpital Foch, Suresnes, France; Study Chair: Marc Fischler, MD, Hôpital Foch, Suresnes, France

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: indication; All terminal; leading; lung transplantation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 2014-A00538-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No