Back to results

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

Primary Purpose

Lung Diseases

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Self-hypnosis

Lung transplantation

Standard post-operative pain management

About this trial

This is an interventional supportive care trial for Lung Diseases focused on measuring All terminal, leading, indication, lung transplantation

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-hypnosis

Usual pain management

Arm Description

Patients trained to self-hypnosis before surgery

Patients receiving the usual post-operative pain management protocols

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02216539

First Posted

August 13, 2014

Last Updated

May 12, 2016

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

1. Study Identification

Unique Protocol Identification Number

NCT02216539

Brief Title

Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation

Acronym

AUTOHYPNOSE-TP

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Change of sponsor

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases

Keywords

All terminal, leading, indication, lung transplantation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-hypnosis

Arm Type

Experimental

Arm Description

Patients trained to self-hypnosis before surgery

Arm Title

Usual pain management

Arm Type

Active Comparator

Arm Description

Patients receiving the usual post-operative pain management protocols

Intervention Type

Behavioral

Intervention Name(s)

Self-hypnosis

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Lung transplantation

Intervention Type

Other

Intervention Name(s)

Standard post-operative pain management

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

one month after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mireille Michel-Cherqui, MD

Organizational Affiliation

Hôpital Foch, Suresnes, France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc Fischler, MD

Organizational Affiliation

Hôpital Foch, Suresnes, France

Official's Role

Study Chair

Facility Information:

Facility Name

Hôpital Foch

City

Suresnes

ZIP/Postal Code

92151

Country

France

12. IPD Sharing Statement

Learn more about this trial

Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation

We'll reach out to this number within 24 hrs