Hypnosis in Interventional Electrophysiology (PAINLESS)

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

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.

Study Overview

• Status: Completed
• Conditions: Flutter, Atrial; Over 18 Years Old
• Intervention / Treatment: Other: Placebo; Other: Hypnosis

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • CHU De Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Placebo; Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Experimental: 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.	Other: Hypnosis; Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.

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;

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 2017-A01936-47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No