A Virtual Reality Relaxation Intervention for Clinical Staff
Primary Purpose
Psychological Burnout, Stress, Psychological, Mental Health Burden
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Reality Relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Burnout focused on measuring virtual reality, relaxation, healthcare staff
Eligibility Criteria
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.
Sites / Locations
- South London and Maudsley NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VR Relaxation
Arm Description
a 5-week course of 20-min sessions of VR relaxation
Outcomes
Primary Outcome Measures
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
Number of people who consent to take part
as assessed via a tally of acceptances and refusals
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
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
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
Secondary Outcome Measures
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.
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
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05601908
Brief Title
A Virtual Reality Relaxation Intervention for Clinical Staff
Official Title
Feasibility and Acceptability of a Virtual Reality Relaxation Intervention for Mental Health Staff
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Burnout, Stress, Psychological, Mental Health Burden
Keywords
virtual reality, relaxation, healthcare staff
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post-test
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VR Relaxation
Arm Type
Experimental
Arm Description
a 5-week course of 20-min sessions of VR relaxation
Intervention Type
Other
Intervention Name(s)
Virtual Reality Relaxation
Other Intervention Name(s)
VR relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of wards and community teams agree to hosting the project and number that do not agree to hosting the VR relaxation project
Description
as assessed via a tally of acceptances and refusals
Time Frame
Through study completion, an average of 22 months
Title
Number of people who consent to take part
Description
as assessed via a tally of acceptances and refusals
Time Frame
Through study completion, an average of 22 months
Title
Average adherence to VR relaxation sessions and assessments
Description
as assessed via a record of number of VR sessions and number of assessments attended, and number of VR sessions and assessments not attended
Time Frame
Throughout length of participation in the VR trial, 5 weeks
Title
Number of Participants With Treatment-Related Adverse Events
Description
as assessed via a tally of all medical effects observed and all medical effects reported by participants
Time Frame
Through study completion, an average of 22 months
Title
What proportion of participants adhere to the 20-min VR session
Description
as assessed via a record of number of VR sessions completed in full (20 minutes) and number of sessions aborted before completion
Time Frame
Throughout length of participation in the VR trial, 5 weeks
Secondary Outcome Measure Information:
Title
Change in The Perceived Stress Scale (PSS-10) score
Description
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.
Time Frame
baseline, 5-weeks
Title
Change in The Penn State Worry Questionnaire (PSWQ) score
Description
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
Time Frame
baseline, 5-weeks
Title
Change in The Oldenburg Burnout Inventory (OLBI) score
Description
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.
Time Frame
baseline, 5-weeks
Title
Change in The Pittsburgh Sleep Quality Index (PSQI) score
Description
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.
Time Frame
baseline, 5-weeks
Title
What proportion of participants successfully complete their personal goal, this will be measured using the Goal Attainment Scaling (GAS)
Description
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
Time Frame
baseline, 5-weeks
Other Pre-specified Outcome Measures:
Title
Change in the Visual Analogue Scale (VAS) 10-point scale score assessing Stress
Description
Participants asked: 'how stressed do you feel right now?' on a 10-point scale where 0 is not at all and 10 is extremely stressed
Time Frame
Before and after each VR session, throughout length of participation in the VR trial, 5 weeks
Title
Change in the Visual Analogue Scale (VAS) 10-point scale score assessing relaxation
Description
Participants asked: 'how relaxed do you feel right now?' on a 10-point scale where 0 is not at all and 10 is extremely relaxed
Time Frame
Before and after each VR session, throughout length of participation in the VR trial, 5 weeks
Title
Change in the Visual Analogue Scale (VAS) 10-point scale score assessing tiredness
Description
Participants asked: 'how sleepy do you feel right now?' on a 10-point scale where 0 is not at all and 10 is extremely sleepy
Time Frame
Before and each each VR session, throughout length of participation in the VR trial, 5 weeks
Title
Change in the Visual Analogue Scale (VAS) 10-point scale score assessing connection to nature
Description
Participants asked: 'how connected to nature do you feel right now?' on a 10-point scale where 0 is not at all and 10 is extremely connected
Time Frame
Before and after each VR session, throughout length of participation in the VR trial, 5 weeks
Title
Change in The Patient Health Questionnaire-2 (PHDQ-2) score
Description
Scores range from 0 to 6 with higher scores indicative of lower mood. A score of 3 or above has been used to indicate possible depression.
Time Frame
Before and after each VR session, throughout length of participation in the VR trial, 5 weeks
Title
Change in The Generalized Anxiety Disorder 2-item scale score
Description
Scores range from 0 to 6 with higher scores indicative of greater generalised anxiety. A score of 3 or above has been used to indicate possible generalized anxiety disorder.
Time Frame
before each VR relaxation session throughout length of participation in the VR trial, 5 weeks
Title
Change in the Visual Analogue Scale (VAS) 10-point scale score assessing sleep quality
Description
Participants asked to rate how well they have been sleeping in the last week on a 10-point scale where 0 is poorly and 10 is very well
Time Frame
before each VR relaxation session throughout length of participation in the VR trial, 5 weeks
Title
Change in the Slate-Usoh-Steed Sense of Presence Questionnaire (SUS) score modified to this study's VR 'relaxing environment' to measure sense of presence in the virtual environments
Description
Scores range from 6 to 42 with higher scores indicative of a greater sense of presence in the VR environment.
Time Frame
after each VR relaxation session throughout length of participation in the VR trial, 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca N Martland, PhD
Phone
07551988500
Email
becca_martland@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Riches, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
South London and Maudsley NHS Trust
City
London
State/Province
Greater London
ZIP/Postal Code
BR3 3BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Martland, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21533847
Citation
Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.
Results Reference
background
PubMed Identifier
29276631
Citation
d'Ettorre G, Pellicani V. Workplace Violence Toward Mental Healthcare Workers Employed in Psychiatric Wards. Saf Health Work. 2017 Dec;8(4):337-342. doi: 10.1016/j.shaw.2017.01.004. Epub 2017 Feb 6.
Results Reference
background
PubMed Identifier
29243348
Citation
Johnson J, Hall LH, Berzins K, Baker J, Melling K, Thompson C. Mental healthcare staff well-being and burnout: A narrative review of trends, causes, implications, and recommendations for future interventions. Int J Ment Health Nurs. 2018 Feb;27(1):20-32. doi: 10.1111/inm.12416. Epub 2017 Dec 15.
Results Reference
background
PubMed Identifier
34120220
Citation
Riches S, Azevedo L, Bird L, Pisani S, Valmaggia L. Virtual reality relaxation for the general population: a systematic review. Soc Psychiatry Psychiatr Epidemiol. 2021 Oct;56(10):1707-1727. doi: 10.1007/s00127-021-02110-z. Epub 2021 Jun 13.
Results Reference
background
PubMed Identifier
21035130
Citation
Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
Results Reference
background
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A Virtual Reality Relaxation Intervention for Clinical Staff
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