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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02237976
Other study ID # 2014/47
Secondary ID 2014-A00538-39
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2014
Est. completion date July 31, 2018

Study information

Verified date March 2022
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date July 31, 2018
Est. primary completion date April 26, 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-hypnosis

Routine practice


Locations

Country Name City State
France Hôpital Foch Suresnes Hauts De Seine

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Forced expiratory volume in one second Forced expiratory volume in one second is measured 4 months after transplantation. 6 months
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