Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2017-10-02
2019-09-26
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Placebo
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
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.
Hypnosis
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
Interventions
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Hypnosis
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
Placebo
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Eligibility Criteria
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Inclusion Criteria
* Surgery ablation of atrial flutter
* Agreement to participate of the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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CHU DE Poitiers
Poitiers, , France
Countries
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Other Identifiers
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2017-A01936-47
Identifier Type: -
Identifier Source: org_study_id
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