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

Completed (inferred)Not a drug-phase studyProgressive MSISRCTN76033536

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • -

What it measured

Main measures

  • 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

    VisionFeasibility

Other measures (1)

  • 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

    FatiguePainMood and sleepQuality of life (reported by participants)Feasibility

Who could take part

Progressive MS · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 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: 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)

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord. People with (MS often struggle as much with “hidden symptoms” of MS as with more “visible” symptoms (e.g. difficulty walking; speech difficulties). HSMS include fatigue, pain, depression, poor sleep and anxiety. Treating HSMS can be challenging. Medicines can help mood and pain, but may worsen fatigue and have side effects. Non-drug treatments including relaxation, mindfulness and exercise may be helpful but can be difficult for patients to access. There is a need for new effective strategies to help patients manage their symptoms which are engaging, effective, acceptable and accessible. Virtual reality (VR) provides an immersive escape into new environments and experiences which would not otherwise be accessible. This can help to relax and distract from unpleasant symptoms. This is an initial feasibility study to explore the home use of VR for symptom management by people with MS. Who can participate? Patients aged 18 years or over with progressive MS and at least one hidden symptom of MS What does the study involve? Participants are randomly divided into two groups of five. The first group will be provided with a simple VR headset at home. They can use it to try activities like swimming with dolphins, watching the sunrise at the beach or guided meditation and mindfulness. The second group will be provided with access to pre-recorded audio-guided meditation and relaxation sessions. Both groups will use the equipment at least three times per week for 6 weeks. Participants will be asked about their symptoms before the study starts, halfway through, at the end of 6 weeks and 1 month after the study to look for longer-lasting effects. The researchers will look at how the study was delivered, how easy it was to recruit participants, and how many dropped out. They will ask participants about their experiences and how the study could be improved. They will use their findings to design a larger trial to study the effects of VR on HSMS. What are the possible benefits and risks of participating? The researchers can’t promise that taking part in this study will help. It is hoped that both of the interventions may help participants to feel more relaxed and that this may help with some of the symptoms commonly seen in MS, including fatigue, pain, depression and anxiety. However, the researchers cannot guarantee that this will happen. They are interested in finding out whether the interventions have any effect on the symptoms that can occur with MS, especially pain, and they are hoping that the results of this study will help them to go on to develop a much larger trial where they can gather more information. Particiants may find that they can’t get on with the VR headset or with the MP3 player. They may find that they get bored of using them, or they don’t like the programmes. Some people can find the VR headset makes them feel claustrophobic or uncomfortable, or they can feel sick (like motion sickness). Some people can find being asked about their mood or their symptoms can make them feel worse. Where is the study run from? University Hospitals of Derby and Burton NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? September 2019 to May 2023 Who is funding the study? British Society of Rehabilitation Medicine (UK) Who is the main contact? Dr Laura Edwards laura.edwards@nottingham.ac.uk

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History

    1. Started

      Oct 2021

    2. Finished

      May 2023

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