Randomised study comparing VR and standard on cardiac surgery patients
Research type
Research Study
Full title
A Randomised pilot Study to evaluate the use of Virtual Reality Mindfulness and Wellbeing session during pre- and post-surgical admission to reduce anxiety and stress undergoing first time elective cardiac surgery – RSVR study.
IRAS ID
335136
Contact name
Bhuvaneswari Krishnamoorthy
Contact email
Sponsor organisation
The University of Salford
Duration of Study in the UK
0 years, 6 months, 25 days
Research summary
Background (Lay):
Non-drug methods like hypnosis and Virtual Reality (VR) are used alongside other treatments to help patients with anxiety and different types of pain. But when it comes to using VR to help people who are having heart surgery, there haven't been many studies. One reason for this might be that using VR for this purpose is relatively new, VR technology is changing quickly, and it can be expensive to get started with VR.
Scientific
The use of mindfulness and relaxation techniques such as immersion in nature and natural landscapes is steadily rising in the clinical care [1]. Different non-pharmacological techniques, including hypnosis and immersive virtual reality (VR) are currently used as complementary tools in the treatment of acute and chronic pain. Anxiety, stress are other common problems for patients undergoing cardiac surgery. [1,2,3] Many practices have sought to develop nonpharmacologic strategies to ameliorate preoperative stress, anxiety and pain. Hendricks et al. showed that in post-cardiac surgery patients immersive VR significantly reduced multiple measures of state anxiety compared with baseline, including feeling tense, strained, and upset.[4]. However, the control group in their study had an intervention of tabletop games and standard care was not measured within either group.
Aims and objectives:
This pilot study will assess immersive head mounted VR simulations in adult patients undergoing first time elective cardiac surgery to understand the impact on patient anxiety and stress. The primary objective is to assess anxiety and stress levels between two groups.
Methods:
Cardiac surgery patients (n = 30) undergoing first time elective/urgent-in-patient cardiac surgery at Wythenshawe Hospital site will be randomly assigned equally to two arms (control with placebo or VR) using a computer-generated randomisation list. The control group will receive standard care admission process which includes a surgical information booklet, online Microsoft Teams experiential talk about the surgery pathway by a heart charity and two sessions of 15 minutes music session with WorWoder Wireless blue tooth headset as a placebo pre- and post-surgery as same timings as intervention group. The VR intervention group will receive the same as the control group with the addition of two VR sessions: session one 15 minutes VR session will be one hour before surgery and sessions two on day 3 evening (around 6pm) postoperatively. Patients who are ventilated on day 3 will be removed from the study and additional patients will be recruited on both groups. Questionnaires will be handed to the patients pre- and post-surgery in both groups to rate their levels of anxiety and stress level (STAI), physiological assessments, VR experience and VR-absorption (VAS) in intervention group will be recorded.
In addition, we will explore if there is association between salivary cortisol levels as a potential biomarker for stress and self-completed questionnaires anxiety level (STAI). We will obtain four samples of before and after placebo/VR intervention pre- and post-surgery to see the co-relation.
Expected outcomes:
This study will identify whether the use of VR technology has the potential impact to reduce pre and post operative anxiety and stress.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
23/NW/0345
Date of REC Opinion
2 Jan 2024
REC opinion
Further Information Favourable Opinion