Hypnosis in Interventional Electrophysiology

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?

Conditions
-----------------
Flutter, Atrial, Over 18 Years Old

Intervention / Treatment
-----------------
* Other: Hypnosis
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Surgery ablation of atrial flutter Agreement to participate of the study Exclusion Criteria: Person who does not speak French or deaf Chronic pain with the visual analogue scale > 5 Psychiatric pathology Contraindication to paracetamol, lidocaine, morphine Pregnant women, or breast-feeding women or without effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Other: Placebo<br>* Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones<br>|
| Experimental: Hypnosis<br>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: induction: attention of the patient fixed on an object or a part of the body, the dissociation where the patient cuts off auditory, visual and tactile perceptions, and finally the opening towards a hypnotic experience thanks to the imaginary. | Other: Hypnosis<br>* Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global pain self-assessment during the procedure | Assessed with visual analogue pain scale | Collected 45 min after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety during the procedure | Visual analog scale self-assessment | Collected after the procedure | 
| Morphine consumption | milligram | Collected after the procedure | 
| Patient sedation evaluation | numerical rating scale; Externally assessed by the electrophysiologist | Collected after the procedure | 
| Pain assessed prospectively during the procedure; | Numerical rating scale score | Evaluated every 5 minutes during the procedure; |