Hypnosis in Interventional Electrophysiology

Flutter, Atrial Clinical Trial

— PAINLESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250871
• Other study ID #: 2017-A01936-47
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: September 26, 2019

Study information

• Verified date: December 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 26, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Flutter, Atrial
• Over 18 Years Old

Intervention

Other:
• Hypnosis
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
• Placebo
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones

Locations

Country	Name	City	State
France	CHU DE Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global pain self-assessment during the procedure	Assessed with visual analogue pain scale	Collected 45 min after the procedure
Secondary	Anxiety during the procedure	Visual analog scale self-assessment	Collected after the procedure
Secondary	Morphine consumption	milligram	Collected after the procedure
Secondary	Patient sedation evaluation	numerical rating scale; Externally assessed by the electrophysiologist	Collected after the procedure
Secondary	Pain assessed prospectively during the procedure;	Numerical rating scale score	Evaluated every 5 minutes during the procedure;