Lung TransplantationSelfHypTpNCT02237976
Self-hypnosis in Patients Awaiting Lung Transplantation
A study testing Self-hypnosis and Routine practice in people with Lung Transplantation, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Self-hypnosis and Routine practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2014to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients aged 15 years or more requiring lung transplantation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation
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.
- Conditions
- Lung Transplantation
- Being tested
- Self-hypnosis, Routine practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosisBehavioural
Routine practiceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-hypnosis |
| Routine practice | Active comparator | No specific intervention Receives: Behavioral: Routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: one month
Secondary outcomes (8)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months
Forced expiratory volume in one second
Forced expiratory volume in one second is measured 4 months after transplantation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study start31 Jul 2014
- Primary completion26 Apr 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237976
- Sponsor's protocol ID
- 2014/47
- Other IDs
- 2014-A00538-39
- Acronym
- SelfHypTp
- Status last verified
- Mar 2022
- First submitted
- 9 Sep 2014
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation
- ClinicalTrials.gov ID
- NCT02237976
- Acronym / sponsor ID
- SelfHypTp / 2014/47
- Conditions
- Lung Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 31 Jul 2014 (actual)
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis | Experimental | Behavioral: Self-hypnosisPatients are trained to practice self-hypnosis wen they are listed for lung transplantation. They are encourage to practice it before and after transplantation. |
| Routine practice | Active comparator | Behavioral: Routine practiceNo specific intervention |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 15 years or more requiring lung transplantation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnosis | Behavioural | Self-hypnosis |
| Routine practice | Behavioural | Routine practice |
Primary outcome
Pain after lung transplantation
Time frame: 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) .
8 secondary outcomes
Pain before and after lung transplantation
Time frame: 6 months
Anxiety
Time frame: 6 months
Coping
Time frame: 6 months
Catastrophism
Time frame: 6 months
Quality of life
Time frame: 6 months
Quality of life related to the procedure
Time frame: 6 months
Practice of self-hypnosis
Time frame: 6 months
Forced expiratory volume in one second
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis and Routine practice in people with Lung Transplantation, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain after lung transplantation (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.