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

A feasibility study of virtual reality relaxation for treating hidden symptoms in people with progressive multiple sclerosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76033536

Enrollment

Registered

2022-02-04

Start date

2021-10-04

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

Randomization: simple randomization via an online system Intervention: 5 participants will attend a brief training and education session to become familiarised with the VR headset and its use (facili

“Relaxation” (week 4) and “Journey to Wellness” (week 8). It is designed for one session to be delivered each day, and once one session has completed, the next session automatically appears for the us

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Feasibility: 1. Recruitment assessed by meeting the recruitment target of 10 participants at 10 weeks from study recruitment opening 2. Retention: rates of drop-out assessed by simple counting at 4, 8 and 12 weeks from randomisation. 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. 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 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.	—

Measure

Time frame

Feasibility: 1. Recruitment assessed by meeting the recruitment target of 10 participants at 10 weeks from study recruitment opening 2. Retention: rates of drop-out assessed by simple counting at 4, 8 and 12 weeks from randomisation. 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. 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 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.

—

Secondary

Measure	Time frame
MS-related outcomes: Participants will complete questionnaires/intervention details as at baseline at the end of weeks 3 and 6 (see below for details of questionnaires). There will be a further set of follow-up questionnaires 1 month after the intervention period ends. Questionnaires can be completed by the participant, by the participant and carer together, or by the participant (with or without carer) with the investigator via telephone, online or in person to try to minimise drop-out and non-completion due to questionnaire burden. 1. Pain measured using the Wong-Baker FACES Pain Rating Scale 2. Quality of life measured using the Leeds MS QoL 3. Fatigue measured using the Fatigue Severity Scale (FSS) 4. Well-being measured using Coop/Wonca charts 5. Sleep measured using the Athens Insomnia Scale 6. Overall MS symptoms measured using the Multiple Sclerosis Impact Scale (MSIS-29) 7. Health status measured using EQ-5D-5L for informing health economics analysis Qualitative outcomes: Participants in each arm will be invited to take part in a more in-depth user experience study at the beginning of the study. This will include real-time user observation of the VR/relaxation programme with opportunistic questioning and in-depth qualitative interviews to explore the experience of using the interventions, barriers or facilitators to use, and any changes that they would recommend for future work. If participants have partners/carers/family members who are willing to participate, the researchers will ask about their experiences of the study and intervention. There are many facets of wellbeing and QoL in MS that will not map onto the selected questionnaires. The researchers will therefore examine issues identified and described by our participants as being important to their experiences. They will seek participant feedback regarding outcome measures. Health economics outcomes: The feasibility of conducting an incremental cost-effectiveness analysis alongside a full RCT	—

Measure

Time frame

MS-related outcomes: Participants will complete questionnaires/intervention details as at baseline at the end of weeks 3 and 6 (see below for details of questionnaires). There will be a further set of follow-up questionnaires 1 month after the intervention period ends. Questionnaires can be completed by the participant, by the participant and carer together, or by the participant (with or without carer) with the investigator via telephone, online or in person to try to minimise drop-out and non-completion due to questionnaire burden. 1. Pain measured using the Wong-Baker FACES Pain Rating Scale 2. Quality of life measured using the Leeds MS QoL 3. Fatigue measured using the Fatigue Severity Scale (FSS) 4. Well-being measured using Coop/Wonca charts 5. Sleep measured using the Athens Insomnia Scale 6. Overall MS symptoms measured using the Multiple Sclerosis Impact Scale (MSIS-29) 7. Health status measured using EQ-5D-5L for informing health economics analysis Qualitative outcomes: Participants in each arm will be invited to take part in a more in-depth user experience study at the beginning of the study. This will include real-time user observation of the VR/relaxation programme with opportunistic questioning and in-depth qualitative interviews to explore the experience of using the interventions, barriers or facilitators to use, and any changes that they would recommend for future work. If participants have partners/carers/family members who are willing to participate, the researchers will ask about their experiences of the study and intervention. There are many facets of wellbeing and QoL in MS that will not map onto the selected questionnaires. The researchers will therefore examine issues identified and described by our participants as being important to their experiences. They will seek participant feedback regarding outcome measures. Health economics outcomes: The feasibility of conducting an incremental cost-effectiveness analysis alongside a full RCT

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026