Self-hypnosis in Patients Awaiting Lung Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation

Conditions
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Lung Transplantation

Intervention / Treatment
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* Behavioral: Self-hypnosis
* Behavioral: Routine practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-hypnosis<br>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<br> <br> |
| Active Comparator: Routine practice<br>No specific intervention | Behavioral: Routine practice<br> <br> |

What is the study measuring?
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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 |