Chest Drain Insertion Assisted by Virtual Reality

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

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Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients\' pain and anxiety

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Detailed Description

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Conditions

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Pneumothorax Spontaneous Primary Pneumothorax Spontaneous Secondary Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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virtual reality headset

Patients in this arm will have a reality helmet placed during chest drain insertion

Group Type EXPERIMENTAL

Virtual Reality Headset

Intervention Type DEVICE

A virtual reality headset will be placed on patients\' head before and during chest drain insertion

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality Headset

A virtual reality headset will be placed on patients\' head before and during chest drain insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Indication of chest drain insertion for pleural effusion or primary spontaneous pneumothorax
* Patient who received clear and loyal information abotu the study protocol
* Patient who consented to participate to the study
* Patient aged 18 years old or older
* Patient affiliated to the french health system

Exclusion Criteria

* Patient aged less than 18 years old
* Patient in emergency situation
* Patient with severe heart condition
* Patient allergic to silicone
* Patient with severe psychiatric or mental disorder
* patient with binocular vision anomaly
* patient with pacemaker or defibrillator
* patient wearing a hearing aid that cannot be removed
* Patients under the influence of alcohol or drugs, nausea, fatigue, emotional or anxiety disorders, migraine, headaches, infectious disease
* Patient with past medical history of epilepsia or convulsion

\-- Persons covered by articles L. 1121-5 and L1121-8 of the French Public Health Code:
* Pregnant, parturient or breast-feeding women,
* Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* adults unable to give their consent
* Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
* Person able to give consent but unable to write
* Person able to give consent but unable to read French
* Patient unable to consent to the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No