Virtual Reality Hypnosis for Thoracic Drain Insertion

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-23

Study Completion Date

2023-09-29

Brief Summary

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The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.

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Detailed Description

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This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted:

* Group 1: Insertion of the drain according to the usual management protocol.
* Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Conditions

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Pneumopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HypnoVR

Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Group Type EXPERIMENTAL

HypnoVR

Intervention Type DEVICE

Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Usual care

Insertion of the drain according to the usual management protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HypnoVR

Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient 18 years of age or older, having read and signed the consent form for participation in the study
* Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.

Exclusion Criteria

* Patient under legal protection, guardianship or trusteeship
* Pregnant or breastfeeding patient
* Patient not affiliated to the French social security system
* Hearing or visual disturbances contraindicating the use of virtual reality headphones
* Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
* Unbalanced epilepsy
* Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol
* Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion)
* Concurrent participation in other research or during a period of exclusion from previous research

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No