Self-hypnosis in Patients Awaiting Lung Transplantation (SelfHypTp)

Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation

The proposed study is designed to utilize a self-hypnosis training program for patients awaiting lung transplantation. This technique can increase their well being, particularly by decreasing postoperative pain.

Study Overview

• Status: Completed
• Conditions: Lung Transplantation
• Intervention / Treatment: Behavioral: Self-hypnosis; Behavioral: Routine practice

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts De Seine
    • Suresnes, Hauts De Seine, France, 92151
      • Hôpital FOCH

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• patients aged 15 years or more requiring lung transplantation

Exclusion Criteria:

• patients who cannot participate in learning sessions of self-hypnosis for cultural , cognitive or environmental reasons
• patients who have participated in only one learning self-hypnosis session before transplantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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 are trained to practice self-hypnosis wen they are listed for lung transplantation. They are encourage to practice it before and after transplantation.	Behavioral: Self-hypnosis
Active Comparator: Routine practice; No specific intervention	Behavioral: Routine practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after lung transplantation	Mean pain score in the 48 hours preceding the consultation performed one month after lung transplantation. Pain score is determined by the patient on a visual analogue scale (VAS) .	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain before and after lung transplantation	Pain score is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation	6 months
Anxiety	Anxiety is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation. Anxiety is also determined by; the State Anxiety Inventory and the Trait Anxiety Inventory at the time of inscription on waiting list for transplantation,; the State Anxiety Inventory one and four months after transplantation.	6 months
Coping	Coping is determined by the patient (Coping Strategies Questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation	6 months
Catastrophism	Catastrophism is determined by the patient (Sullivan questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation	6 months
Quality of life	Quality of life is determined by the patient (SF12 questionnaire) at the time of inscription on waiting list for transplantation, one and four months after transplantation	6 months
Quality of life related to the procedure	Quality of life related to the procedure is determined by the patient using a specific questionnaire (Ringsted et al. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. The Clinical Journal of Pain 2013;29(9):791-799) four months after transplantation	6 months
Practice of self-hypnosis	Practice of self-hypnosis is determined by the patient using a specific questionnaire at the 8th day post transplantation, one and four months after transplantation.	6 months
Forced expiratory volume in one second	Forced expiratory volume in one second is measured 4 months after transplantation.	6 months

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2014
• Primary Completion (Actual): April 26, 2017
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 9, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2014/47; 2014-A00538-39 (Other Identifier: ANSM)