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Virtual Sedation During Elective Procedures in the Cathlab

NCT06171620 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-12-14

No results posted yet for this study

Summary

This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab).

To assess the effectiveness of VR in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. A sample of patients scheduled for a planned procedure in the cathlab of UZ Brussel will be selected using convenience sampling.

Participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. The control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention.

The primary outcome of anxiety will be measured using the Visual Analog Scale (VAS) for anxiety and the State-Trait Anxiety Inventory (STAI) questionnaire. The secondary outcome of pain will be measured using the VAS scale for pain.

Other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. The physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the VR headset from the operators' perspective.

The outcomes of the two groups will be statistically compared using the SPSS software package.

Conditions

Interventions

DEVICE

Virtual reality headset

Distraction therapy using a virtual reality headset. Participants will access a digitally created environment such as a forest or sub sea exploration with relaxing auditory cues.

OTHER

Standard of care

Elective procedure performed as planned according to current standard of care in the hospital.

Sponsors & Collaborators

  • University Ghent

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Johan De Sutter, PHD, MD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171620 on ClinicalTrials.gov