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Hypnosis in Interventional Electrophysiology (PAINLESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250871
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Flutter, Atrial Over 18 Years Old Other: Hypnosis Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : September 23, 2019
Actual Study Completion Date : September 26, 2019
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
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.
 Other: Placebo
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Experimental: Hypnosis

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


Outcome Measures
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Primary Outcome Measures :
  1. Global pain self-assessment during the procedure [ Time Frame: Collected 45 min after the procedure ]
    Assessed with visual analogue pain scale


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250871


Locations
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France
CHU DE Poitiers
Poitiers, France
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03250871    
Other Study ID Numbers: 2017-A01936-47
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes