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
About this trial
This is an interventional supportive care trial for Flutter, Atrial
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
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
NCT ID
NCT03250871
First Posted
August 11, 2017
Last Updated
February 6, 2020
Sponsor
Poitiers University Hospital
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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