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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years or older with written informed consent

Patients undergoing surgical CABG

Disqualifiers

Major comorbidities besides coronary artery disease

Complicated surgical procedure

Hearing and/or visual impairments

Psychiatric impairments

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality distraction therapy

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Virtual Reality groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Numeric Rating Scale (NRS)

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.

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

State- Trait Anxiety Inventory 6 questionnaire

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

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

Quality of Recovery-15

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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