NCT02237976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

September 9, 2014

Last Update Submit

March 15, 2022

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Pain before and after lung transplantation

    6 months

  • Anxiety

    6 months

  • Coping

    6 months

  • Catastrophism

    6 months

  • Quality of life

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Self-hypnosis

EXPERIMENTAL

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

Routine practice

ACTIVE COMPARATOR

No specific intervention

Behavioral: Routine practice

Interventions

Self-hypnosisBEHAVIORAL
Self-hypnosis
Routine practiceBEHAVIORAL
Routine practice

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 15 years or more requiring lung transplantation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, Hauts De Seine, 92151, France

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mireille Michel-Cherqui, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

July 31, 2014

Primary Completion

April 26, 2017

Study Completion

July 31, 2018

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

FR(1)