NCT07132710

Brief Summary

The benefits of virtual reality (VR) in managing pain and anxiety for critical care patients has never been demonstrated, even if a positive effect has been demonstrated in other populations of patients. A preliminary survey in 8 critical care units equipped with the VR mask, identified a under-use of masks by critical care teams. Before addressing the question of the effectiveness of the VR mask in a population of critical care patients, we must first identify the barriers and facilitators to its use and propose a new organization in critical care units promoting the use of VR mask by autonomous caregivers. A qualitative study will be conducted with patients and caregivers of a critical care unit to identify the barriers and facilitators to the use of virtual reality masks in the management of pain and anxiety by caregivers.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 13, 2025

Last Update Submit

August 13, 2025

Conditions

Keywords

Patient experiencevirtual realitycritical carejob satisfactionorganizational innovationqualitative study

Outcome Measures

Primary Outcomes (1)

  • Identify the barriers and facilitators to the use of virtual reality mask by paramedical staff in the management of invasive care for critical care patients

    Patients and caregivers of a cardiac critical care unit will be interviewed (semi-structured interviews) to gather their perceptions on the use of virtual reality mask for pain and anxiety management in invasive care for critical care patients

    Participants will be interviewed once (about one-hour interview)

Study Arms (1)

VR mask potential users in critical care

Patients and caregivers of cardiac critical care units likely to use a VR mask for therapeutic purposes

Other: Semi-structured interviews

Interventions

Patients and caregivers will be interviewed about the barriers and facilitators to the use of VR masks in the management of pain and anxiety, in order to propose organizational changes that encourage their use.

VR mask potential users in critical care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As for the caregivers, the team is currently made up of 42 nurses and 35 care assitants, so our sample will be 12 nurses and 8 care assistants to be representative of the team. As for the patients,10 volunteer from the cardiac critical care unit who meet the eligibility criteria will be selected to ensure the greatest possible diversity of patient profiles.

You may qualify if:

  • Volunteer caregivers working in the cardiac critical care unit for at least 6 months.
  • Adult patients treated in the unit with a condition requiring at least one potentially painful and anxiety-provoking invasive procedure (e.g., Central Venous Line placement, Arterial Catheter Insertion, ...) allowing the use of the VR mask.
  • Patients able to understand the instructions without language barriers, to ensure the validity of the interviews and the quality of the data collected.

You may not qualify if:

  • Staff not volunteering to participate in the study.
  • Patients whose condition presents a medical contraindication to the use of VR mask or who present cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel - Hospices Civils de Lyon

Bron, France, 69500, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 20, 2025

Study Start

March 1, 2025

Primary Completion

June 1, 2025

Study Completion

March 1, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Locations