NCT05601908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

October 7, 2022

Last Update Submit

January 29, 2024

Conditions

Keywords

virtual realityrelaxationhealthcare staff

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Change in The Perceived Stress Scale (PSS-10) score

    baseline, 5-weeks

  • Change in The Penn State Worry Questionnaire (PSWQ) score

    baseline, 5-weeks

  • Change in The Oldenburg Burnout Inventory (OLBI) score

    baseline, 5-weeks

  • Change in The Pittsburgh Sleep Quality Index (PSQI) score

    baseline, 5-weeks

  • What proportion of participants successfully complete their personal goal, this will be measured using the Goal Attainment Scaling (GAS)

    baseline, 5-weeks

Other Outcomes (8)

  • Change in the Visual Analogue Scale (VAS) 10-point scale score assessing Stress

    Before and after each VR session, throughout length of participation in the VR trial, 5 weeks

  • Change in the Visual Analogue Scale (VAS) 10-point scale score assessing relaxation

    Before and after each VR session, throughout length of participation in the VR trial, 5 weeks

  • Change in the Visual Analogue Scale (VAS) 10-point scale score assessing tiredness

    Before and each each VR session, throughout length of participation in the VR trial, 5 weeks

  • +5 more other outcomes

Study Arms (1)

VR Relaxation

EXPERIMENTAL

a 5-week course of 20-min sessions of VR relaxation

Other: Virtual Reality Relaxation

Interventions

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.

Also known as: VR relaxation
VR Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South London and Maudsley NHS Trust

London, Greater London, BR3 3BX, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 21533847BACKGROUND
  • 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.

    PMID: 29276631BACKGROUND
  • 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.

    PMID: 29243348BACKGROUND
  • 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.

    PMID: 34120220BACKGROUND
  • 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.

    PMID: 21035130BACKGROUND

MeSH Terms

Conditions

Burnout, PsychologicalStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Simon Riches, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre-post-test
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2022

First Posted

November 1, 2022

Study Start

December 1, 2022

Primary Completion

September 30, 2023

Study Completion

December 30, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations