Hypnosis in Interventional Electrophysiology (PAINLESS)

Poitiers University Hospital

Status: Completed

Conditions: Flutter, Atrial; Over 18 Years Old

Treatments: Other: Hypnosis; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03250871

2017-A01936-47

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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.

Treatment:

Other: Placebo

Hypnosis

Experimental group

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.

Treatment:

Other: Hypnosis