Hypnosis in Interventional Electrophysiology (PAINLESS)
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|ClinicalTrials.gov Identifier: NCT03250871|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 10, 2020
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.
Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.
Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.
The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.
|Condition or disease||Intervention/treatment||Phase|
|Flutter, Atrial Over 18 Years Old||Other: Hypnosis Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?|
|Actual Study Start Date :||October 2, 2017|
|Actual Primary Completion Date :||September 23, 2019|
|Actual Study Completion Date :||September 26, 2019|
Placebo Comparator: Placebo
Placebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery.
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion.
It is divided into three phases:
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
- Global pain self-assessment during the procedure [ Time Frame: Collected 45 min after the procedure ]Assessed with visual analogue pain scale
- Anxiety during the procedure [ Time Frame: Collected after the procedure ]Visual analog scale self-assessment
- Morphine consumption [ Time Frame: Collected after the procedure ]milligram
- Patient sedation evaluation [ Time Frame: Collected after the procedure ]numerical rating scale; Externally assessed by the electrophysiologist
- Pain assessed prospectively during the procedure; [ Time Frame: Evaluated every 5 minutes during the procedure; ]Numerical rating scale score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250871
|CHU DE Poitiers|