Hypnosis in Interventional Electrophysiology

Not Applicable

Completed

• Conditions: Over 18 Years Old; Flutter, Atrial
• Interventions: Other: Placebo; Other: Hypnosis

• Registration Number: NCT03250871
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Study Start: 2017-10-02
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Hypnosis	Hypnosis	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.

Primary Outcome Measures

Name	Time	Method
Global pain self-assessment during the procedure	Collected 45 min after the procedure	Assessed with visual analogue pain scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU DE Poitiers; 🇫🇷 Poitiers, France