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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02216539
Other study ID # 2014-A00538-39
Secondary ID
Status Terminated
Phase N/A
First received August 13, 2014
Last updated May 12, 2016
Start date July 2014

Study information

Verified date May 2016
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 90 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-hypnosis
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
Procedure:
Lung transplantation

Other:
Standard post-operative pain management
Post-operative pain management treatments as per usual protocols in the hospital

Locations

Country Name City State
France Hôpital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one month after transplantation No
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