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Hypnosis in Interventional Electrophysiology (PAINLESS)

Primary Purpose

Flutter, Atrial, Over 18 Years Old

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypnosis
Placebo
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Flutter, Atrial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU DE Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Hypnosis

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Global pain self-assessment during the procedure
Assessed with visual analogue pain scale

Secondary Outcome Measures

Anxiety during the procedure
Visual analog scale self-assessment
Morphine consumption
milligram
Patient sedation evaluation
numerical rating scale; Externally assessed by the electrophysiologist
Pain assessed prospectively during the procedure;
Numerical rating scale score

Full Information

First Posted
August 11, 2017
Last Updated
February 6, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03250871
Brief Title
Hypnosis in Interventional Electrophysiology
Acronym
PAINLESS
Official Title
Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
September 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flutter, Atrial, Over 18 Years Old

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hypnosis
Intervention Description
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Primary Outcome Measure Information:
Title
Global pain self-assessment during the procedure
Description
Assessed with visual analogue pain scale
Time Frame
Collected 45 min after the procedure
Secondary Outcome Measure Information:
Title
Anxiety during the procedure
Description
Visual analog scale self-assessment
Time Frame
Collected after the procedure
Title
Morphine consumption
Description
milligram
Time Frame
Collected after the procedure
Title
Patient sedation evaluation
Description
numerical rating scale; Externally assessed by the electrophysiologist
Time Frame
Collected after the procedure
Title
Pain assessed prospectively during the procedure;
Description
Numerical rating scale score
Time Frame
Evaluated every 5 minutes during the procedure;

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU DE Poitiers
City
Poitiers
Country
France

12. IPD Sharing Statement

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Hypnosis in Interventional Electrophysiology

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