REVDOU: Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

Sponsor

Centre Chirurgical Marie Lannelongue (Other)

Overall Status

Recruiting

CT.gov ID

NCT04731792

Collaborator

(none)

152

Enrollment

Location

Arms

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Marie Lannelongue Hospital is a hospital specialized in lung transplantation. Lung transplant patients require regular check-ups by bronchial fibroscopy. This examination is known to be anxious, stressful and sometimes painful. These patients take many medications (immunosuppressants, antibiotics....) that may interact with analgesic or anxiolytic drugs.

The objective is to propose to HML lung transplant patients a virtual reality solution containing visual and auditory 3D experiences to fight against anxiety and pain during repetitive and anxiogenic examinations such as bronchial fibroscopies.

Translated with www.DeepL.com/Translator (free version)

Condition or Disease	Intervention/Treatment	Phase
Anxiety Stress Pain Bronchial Fibroscopy Pulmonary Transplantation	Other: Virtual Reality	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

152 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Therapeutic Virtual Reality: Helps Reduce Anxiety and Pain During Bronchial Fibroscopies in Lung Transplant Patients.

Actual Study Start Date :

Jan 14, 2021

Anticipated Primary Completion Date :

Jan 14, 2024

Anticipated Study Completion Date :

Feb 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality group	Other: Virtual Reality a bronchial fibroscopy with a virtual reality helmet
No Intervention: control group

Arm

Intervention/Treatment

Experimental: Virtual Reality group

Other: Virtual Reality

a bronchial fibroscopy with a virtual reality helmet

No Intervention: control group

Outcome Measures

Primary Outcome Measures

Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified). [1 day]

Secondary Outcome Measures

Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain) [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with a lung or cardio-pulmonary transplant
Adults (age > 18 years old)
Patient who give their informed consent for the protocol
Patient requiring a bronchial fibroscopy and having already had at least one - bronchial fibroscopy without virtual reality

Exclusion Criteria:

children

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson		France	92350

Sponsors and Collaborators

Centre Chirurgical Marie Lannelongue

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Chirurgical Marie Lannelongue

ClinicalTrials.gov Identifier:

NCT04731792

Other Study ID Numbers:

2020-A00658-31

First Posted:

Feb 1, 2021

Last Update Posted:

Feb 1, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Feb 1, 2021