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NCT Number: NCT06001502

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

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.

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Key information

Conditions

Post Operative Pain Coronary Artery Bypass Grafting Heart Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Anxiety Postoperative Complications Signs and Symptoms Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location status: Recruiting

Location contact

Sulayman El Mathari, MD

CONTACT

[email protected]

+31 205668188

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years or older with written informed consent
  • Patients undergoing surgical CABG

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

Treatment and study plan

Virtual Reality distraction therapy

Device

The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings

Other names: Healthy Mind VR device

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: Post-operative days 1,2 and 3 directly after the VR intervention

    The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties.

  2. State- Trait Anxiety Inventory 6 questionnaire

    Time frame: Post-operative days 1,2 and 3 directly after the VR intervention

    The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score

  3. Quality of Recovery-15

    Time frame: Post-operative days 1,2 and 3 directly after the VR intervention

    The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Sulayman El Mathari, MD

CONTACT

[email protected]

+31205668188

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: VRECOVERY

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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