A Virtual Reality Relaxation Intervention for Clinical Staff

Study Overview
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Brief Summary
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Clinical staff working in mental health services experience high levels of work-related stress, burnout and poor wellbeing. They may work long hours, experience stress directly related to the emotional demands of the role and clinical responsibility, experience physical and psychological burnout and may experience high rates of workplace violence. Poorer wellbeing and high burnout amongst mental health staff has been associated with poorer quality of patient care, higher absenteeism, higher turnover rates, and low morale. Virtual reality (VR) relaxation is a technique whereby experiences of pleasant/ calming environments are accessed via a head mounted display to promote relaxation. The use of VR relaxation facilities in the workplace may provide a pragmatic approach to enabling employees to de-stress, relax and optimise their mental wellbeing and may reduce turnover and improve stress related sick leave across the National Health Service (NHS) workforce. The research will involve a pre-post-test of 5-weeks of VR relaxation for clinical staff working in mental health settings, including those working in inpatient settings and community teams. The pre-post-test will act as a feasibility trial, the primary aim is thereby to determine whether VR relaxation is feasible and acceptable amongst mental health staff. This feasibility study will evaluate the feasibility and acceptability of a 5-week course of weekly 20-minute sessions of VR relaxation for clinical staff. Feasibility and acceptability measures will be collected and summarised at the end of the trial, including percentage of those recruited who consent to take part, completion and drop-out rates, adverse events, and satisfaction with sessions. The secondary objective is to investigate the impact of the VR relaxation intervention on potential outcome measures for a randomised controlled trial (RCT), including perceived psychological stress, worry, psychological burnout, sleep quality and anxiety. The results from this study will inform a later trial by providing key parameters including recruitment, retention, acceptability, and adherence to the treatment protocol. Additionally, follow-up qualitative interviews will be conducted with staff who engaged in the VR and staff who withdrew, to develop an understanding of attitudes towards the VR relaxation intervention.

Detailed Description
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Participants: Clinical staff affiliated within South London and Maudsley NHS Trust (SLaM) and working in inpatient and outpatient mental health settings will be recruited. The investigators anticipate recruiting 20-25 participants to the study. This number is based on recruiting a big-enough sample to assess the feasibility of the study and of the resources available. Procedure: The study will be advertised to prospective participants via a general email to staff via the clinical team leader and email circulars. Posters will be displayed in staff rooms with a request that anyone interested in taking part contact the research team. Staff who display an interest in the study will be emailed a participant information sheet with study details. Once participants have provided online written informed consent to take part, they will be asked to undergo baseline assessments. Baseline assessments will be conducted online using Qualtrics and include: a socio-demographic questionnaire (age, gender, ethnicity, occupation, clinical setting, years of experience, highest level of education), measures of stress, worry, sleep, and burnout. All together, the baseline assessments will take approximately 15 mins to complete. Following completion of baseline measures, participants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions. Sessions and assessments will be scheduled in working hours around the participant's clinical duties. Before and after each session participants will be asked to complete state-measures of psychological wellbeing, and they will be asked to rate satisfaction with each session at session completion and complete a measure of sense of presence. Following completion of the 5-week VR relaxation course, participants will repeat baseline measures of stress, worry, burnout and sleep. Participants who drop out of the intervention will be invited to complete these measures providing they attend a minimum of one VR session. The investigators endeavour to complete pre-assessment measures within one week prior to the first VR session and end of intervention measures within one-week of participants finishing the course of VR. Study measures will be presented using the online survey platform Qualtrics. Participants will enter data independently with a member of the research time present to assist. Follow-up Qualitative Interviews: Participants will be invited to participate in follow-up interviews and feedback regarding their experiences of the VR relaxation intervention will be sought. It is expected that 20 participants will attend a follow-up interview. Each interview will take approximately 30 minutes to complete. A series of simple open-ended questions will be asked, and participants will answer verbally. The questions will address staff's opinions regarding the acceptability and feasibility of conducting VR relaxation sessions in the workplace, aspects they enjoyed and barriers to implementation. An audio-recording will record responses to these questions when permission has been granted. The qualitative data gained from these questions will be analysed using thematic analysis to understand the main themes.

Official Title
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Feasibility and Acceptability of a Virtual Reality Relaxation Intervention for Mental Health Staff

Conditions
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Psychological Burnout, Stress, Psychological, Mental Health Burden

Intervention / Treatment
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* Other: Virtual Reality Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical staff affiliated with South London and Maudsley National Health Service Trust (SLaM) and working in inpatient and outpatient mental health settings Aged 18 years or older Capacity to provide informed consent. Exclusion Criteria: Staff with a history of epilepsy as there is a possibility that an epileptic episode may be generated by the VR equipment Is aged <18 years old.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-post-test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR Relaxation<br>a 5-week course of 20-min sessions of VR relaxation | Other: Virtual Reality Relaxation<br>* Participants will undergo a 5-week course of 20-min sessions of VR relaxation. The VR device used will be the Oculus Quest wireless head mounted display (HMD) with two handheld controllers. The HMD and software have been provided by a Germany based company called Magic Horizons. Participants will be asked to wear the HMD and will wear headphones to hear audio. Each session will involve participants experiencing two virtual environments designed to promote relaxation, at least one of which will have a small interactive component to aid engagement. Environments will focus on nature and will be paired with soothing music or guided meditation. For example, scenes might include dolphins dancing underwater, a beach with rock pools, waterfalls, a rainforest, green meadows with flowers, mountains with lakes and/or a sandy desert. Participants will be seated throughout all sessions.<br>* Other names: VR relaxation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of wards and community teams agree to hosting the project and number that do not agree to hosting the VR relaxation project | as assessed via a tally of acceptances and refusals | Through study completion, an average of 22 months | 
| Number of people who consent to take part | as assessed via a tally of acceptances and refusals | Through study completion, an average of 22 months | 
| Average adherence to VR relaxation sessions and assessments | as assessed via a record of number of VR sessions and number of assessments attended, and number of VR sessions and assessments not attended | Throughout length of participation in the VR trial, 5 weeks | 
| Number of Participants With Treatment-Related Adverse Events | as assessed via a tally of all medical effects observed and all medical effects reported by participants | Through study completion, an average of 22 months | 
| What proportion of participants adhere to the 20-min VR session | as assessed via a record of number of VR sessions completed in full (20 minutes) and number of sessions aborted before completion | Throughout length of participation in the VR trial, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Perceived Stress Scale (PSS-10) score | PSS-10 scores range between 0 and 40. Lower scores indicate lower perceived stress. A score of 27 or over is considered high perceived stress. | baseline, 5-weeks | 
| Change in The Penn State Worry Questionnaire (PSWQ) score | Scores range from 16 to 80 with higher scores indicative of higher levels of trait worry. A score of 52 or above suggested the person is currently having some problems with worry | baseline, 5-weeks | 
| Change in The Oldenburg Burnout Inventory (OLBI) score | Scores range from 16 to 64 with higher scores indicative of higher burnout. A score of 35 or above has been used to indicate a higher risk of burnout. | baseline, 5-weeks | 
| Change in The Pittsburgh Sleep Quality Index (PSQI) score | Scores range from 0 to 21 with higher scores indicative of greater difficulty with sleep. A score of 5 or above is considered a significant sleep disturbance. | baseline, 5-weeks | 
| What proportion of participants successfully complete their personal goal, this will be measured using the Goal Attainment Scaling (GAS) | personalized training goals (e.g. I would like to be able to sleep better) will be operationalised and measured using the GAS and the investigators will record the number of participants who complete their goal and the number who do not | baseline, 5-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, relaxation, healthcare staff