NCT04731792

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

January 21, 2021

Last Update Submit

January 26, 2021

Conditions

AnxietyStressPainBronchial FibroscopyPulmonary Transplantation

Outcome Measures

Primary Outcomes (1)

  • Visual Analogic Scale (VAS) score from 0 (no anxiety) to 10 (terrified).

    1 day

Secondary Outcomes (1)

  • Evaluation of pain by a score on a numerical scale (EN) from 0 (no pain) to 10 (unbearable pain)

    1 day

Study Arms (2)

Virtual Reality group

EXPERIMENTAL
Other: Virtual Reality

control group

NO INTERVENTION

Interventions

Virtual RealityOTHER

a bronchial fibroscopy with a virtual reality helmet

Virtual Reality group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Cécile DEGOULET

CONTACT

01 40 94 25 98c.degoulet@ghpsj.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 1, 2021

Study Start

January 14, 2021

Primary Completion

January 14, 2024

Study Completion

February 14, 2024

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

FR(1)