The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

Last updated: July 9, 2024
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Panic Disorders

Heart Transplantation

Treatment

Virtual Reality distraction therapy

Clinical Study ID

NCT06001502
NL79616.018.21
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.

Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3.

Participants in the control group will be treated with conventional post-operative care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years or older with written informed consent

  • Patients undergoing surgical CABG

Exclusion

Exclusion Criteria:

  • Major comorbidities besides coronary artery disease

  • Complicated surgical procedure

  • Hearing and/or visual impairments

  • Psychiatric impairments

  • Complaints of vomiting and nausea

  • History of epilepsy

  • Claustrophobia

  • Facial wounds and skin defects at site of application

  • Patients placed in clinical isolation

  • Readmission to the intensive care unit

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Virtual Reality distraction therapy
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
September 01, 2024

Study Description

Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.

Study design: This study is a single-center randomized control trial.

Study population: Patients who have undergone a CABG procedure (n=100).

Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management.

Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.

Connect with a study center

  • Academic Medical Center

    Amsterdam, Noord Holland 1105 AZ
    Netherlands

    Active - Recruiting

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