Hypnosis in Interventional Electrophysiology

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03250871

Acronym

PAINLESS

Enrollment

116

Registered

2017-08-16

Start date

2017-10-02

Completion date

2019-09-26

Last updated

2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flutter, Atrial, Over 18 Years Old

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.

Interventions

OTHERHypnosis

Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.

OTHERPlacebo

Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Pain assessed prospectively during the procedure;	Evaluated every 5 minutes during the procedure;	Numerical rating scale score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026