SelfHypTp: Self-hypnosis in Patients Awaiting Lung Transplantation

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT02237976
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Behavioral: Self-hypnosis; Behavioral: Routine practice	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation
• Actual Study Start Date: Jul 31, 2014
• Actual Primary Completion Date: Apr 26, 2017
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain after lung transplantation [one month]

   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) .

Secondary Outcome Measures

1. Pain before and after lung transplantation [6 months]

   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

2. Anxiety [6 months]

   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.

3. Coping [6 months]

   Coping is determined by the patient (Coping Strategies Questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation

4. Catastrophism [6 months]

   Catastrophism is determined by the patient (Sullivan questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation

5. Quality of life [6 months]

   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. Quality of life related to the procedure [6 months]

   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

7. Practice of self-hypnosis [6 months]

   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.

8. Forced expiratory volume in one second [6 months]

   Forced expiratory volume in one second is measured 4 months after transplantation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Foch	Suresnes	Hauts De Seine	France	92151

Sponsors and Collaborators

• Hopital Foch

Investigators

• Principal Investigator: Mireille Michel-Cherqui, MD, Hopital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT02237976
• Other Study ID Numbers: 2014/47; 2014-A00538-39
• First Posted: Sep 12, 2014
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

Study Results

No Results Posted as of Mar 16, 2022