Home-based virtual reality for help with symptoms of multiple sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN76033536
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-04
• Study Completion: 2023-05-31
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Progressive multiple sclerosis (PMS) (primary or secondary) (OR friend/relative/carer of a person with PMS)
2. Aged 18 years or over
3. Capable of giving informed consent
4. Participant able to don and doff headset and/or indicate wish for headset to be donned and doffed
5. At least one hidden symptom of MS (HSMS)

Exclusion Criteria

1. Psychotic symptoms (delusions/hallucinations)
2. History of seizures/motion sickness
3. Unable to wear headset
4. Unable to complete outcome measures (including with assistance)
5. Unable to view VR
6. Unable to hear relaxation recordings
7. Recurrent ear infections or blockages (may make use of headphones with MP3 player uncomfortable or difficult)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility:<br>1. Recruitment assessed by meeting the recruitment target of 10 participants at 10 weeks from study recruitment opening<br>2. Retention: rates of drop-out assessed by simple counting at 4, 8 and 12 weeks from randomisation.<br>3. Study delivery: provision of sufficient reliably-working headsets which are easy for PwMS to don, doff and use, based on participant/carer report at each timepoint and by participant-generated feedback in-between timepoints as required.<br>4. Reliability of use: assessed using the frequency of use recorded by the VR headset and participant reports, and compliance assessed with participant interviews at 4, 8 and 12 weeks<br> <br>The feasibility of conducting an incremental cost-effectiveness analysis alongside a full RCT of the home-based VR intervention over and above the control, assessed by collecting basic health service utilisation data from patients with respect to contacts with primary and secondary health care and social services at 4, 8 and 12 weeks.