Hypnosis in Interventional Electrophysiology

NCT03250871 | Completed

• 1 other identifier: 2017-A01936-47
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Flutter, Atrial; Over 18 Years Old

Outcome Measures

Primary Outcomes (1)

• Global pain self-assessment during the procedure

  Assessed with visual analogue pain scale

  Collected 45 min after the procedure

Secondary Outcomes (4)

• Anxiety during the procedure

  Collected after the procedure

• Morphine consumption

  Collected after the procedure

• Patient sedation evaluation

  Collected after the procedure

• Pain assessed prospectively during the procedure;

  Evaluated every 5 minutes during the procedure;

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Hypnosis

EXPERIMENTAL

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

Interventions

Hypnosis OTHER

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

Hypnosis

Placebo OTHER

Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Surgery ablation of atrial flutter
• Agreement to participate of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU DE Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 16, 2017
• Study Start: October 2, 2017
• Primary Completion: September 23, 2019
• Study Completion: September 26, 2019
• Last Updated: February 10, 2020

Record last verified: 2019-12

Locations

FR (1)