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OpenTrials
Completed

NCT Number: NCT03250871

Hypnosis in Interventional Electrophysiology

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.

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Key information

Conditions

Flutter, Atrial Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Over 18 Years Old Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU DE Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis

Other

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

Placebo

Other

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

Primary outcomes

  1. Global pain self-assessment during the procedure

    Time frame: Collected 45 min after the procedure

    Assessed with visual analogue pain scale

Secondary outcomes

  1. Anxiety during the procedure

    Time frame: Collected after the procedure

    Visual analog scale self-assessment

  2. Morphine consumption

    Time frame: Collected after the procedure

    milligram

  3. Patient sedation evaluation

    Time frame: Collected after the procedure

    numerical rating scale; Externally assessed by the electrophysiologist

  4. Pain assessed prospectively during the procedure;

    Time frame: Evaluated every 5 minutes during the procedure;

    Numerical rating scale score

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: PAINLESS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2017
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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