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Chronic PainNCT04259957

Staff Experiences of Using Virtual Reality in a Pain Management Group

An observational study of Chronic Pain, run by InHealth Group at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Immersive Virtual Reality is a fast developing technology that allows a number of opportunities to engage people in activities that they otherwise might find difficult. For instance exercising in a fun way when they have difficulty exercising in the way they previously enjoyed. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Immersive Virtual Reality
Type of treatment
Medical device
How many people
2 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2020to Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Clinicians working at INHEALTH Pain Management in the West Lancashire CCG area, UK. Clinicians who have worked with patients in the Pain Management Program group using virtual reality.

Who may be able to join

  • Must be a qualified health care professional. Must work for Inhealth Pain Management in the West Lancashire team. As part of the above treating those with chronic (longer than 3 months) non-cancer pain.
  • Must have delivered at lest one session of the Pain Management Program with use of Immersive Virtual Reality.

Who cannot join

  • Any clinician who is voluntarily unwilling to take part in the research.

Trial locations and contacts

1 site in 1 country.

Thomas PH Shelton, MSc contact

07828439152

tom.shelton@nhs.net

United Kingdom1 site
  • Inhealth Pain Management

    Barnsley, South Yorkshire, S71 3GN

    Thomas PH Shelton, MSc, 07828439152, tom.shelton@nhs.net

    Thomas PH Shelton, MSc

Other trials in United Kingdom

About this study

Official title: How do Staff Experience Incorporating Immersive Virtual Reality in a Chronic Pain Management Group: a Qualitative Assessment

Immersive Virtual Reality is a fast developing technology that allows a number of opportunities to engage people in activities that they otherwise might find difficult. For instance exercising in a fun way when they have difficulty exercising in the way they previously enjoyed. Alternatively the immersive nature of the experience might make it easier to engage in tasks in an otherwise distracting world.

The investigators are interested in exploring how Virtual Reality games and programs can help people with Chronic Pain. Working with Researchers at Sheffield Hallam University the research team introduced Virtual Reality headsets and games to people engaging in a Pain Management Program Group lasting 6 weeks for 3 hours a week. This involved NHS patients in the UK, delivered by a physiotherapist and an occupational therapist. This group involved 8 individuals with a variety of chronic pain conditions. Patients used Virtual Reality headsets and games throughout the program to aid exercise and mindfulness activities.

This is a relatively new approach and the investigators are not aware of any other organisations making use of this technology in this way. It would be useful developing its use to explore the issues those leading the Pain Management Group and supporting patients found. Speaking to these individuals in interviews will explore their experiences and feelings deeply and allow us to learn about what worked well and what challenges they faced. These interviews would be conducted in a format of qualitative research that would explore the experiences staff had, and compare it to other experiences of introducing patient-used technology in healthcare.

Read the detailed description

This is a new technology and form of clinical treatment. As such it is not possible to draw on existing literature to give a hypothesis. Rather this research will aim to help form new understanding of this developing technological approach. Subsequently a qualitative approach is best to gain an indepth and detailed understanding of the experiences of the clincians who delivered Virtual Reality in a chronic pain group structure. In the group, around 8 patients with Chronic, non-cancer pain were given the opportunity to use a range of programs; demos for commercially available computer games, a virtual natural world to support use of mindfulness approaches, and a program developed for us by Sheffield Hallam University involving climbing and bow and arrow components.

Individual semi-structured interviews will allow the researchers to focus on aspects of the delivery of the technology and how it might be improved in the future. It will also give the freedom to respond to the participating clinicians and explore previously unanticipated issues or views.

The Pain Management Program Group runs over 6 weeks. Exercise components and mindfulness makes up part of each session and is normally led by the clinician. They are largely made up of educational components that will be led as normal. In these Virtual Reality Pain Management Groups the exercise component will be replaced by active games in a virtual reality environment. This will involve a range of games that engage the patient to move their upper-limbs and trunk. The mindfulness component will place the patient in the immersive digital environment and then encourage them to engage with it by making use of conventional mindfulness exercises.

At a date following the completion of the group, the staff leading the group will be involved in a single semi-structured interview lasting around 30 minutes. Participants will be asked about how they found using Virtual Reality technology in a Pain Management Group, what issues arose that they had to overcome and how they think the sessions need to be developed in the future. Interviews will take place during clinic times over the telephone. Time will be allowed so that staff can take part in these interviews. The interviewer will be another member of staff at the same organisation who has not been involved in the delivery of the Virtual Reality technology. They are also the chief investigator.

The interviews will be recorded directly onto a secure laptop (password protected encryption) and the recordings will be stored on a secure server in a password protected file. It will be transcribed and analysed in Microsoft Word using a thematic approach. This will then be transferred to the Sheffield Hallam University Data Archive following analysis.

Confirmation of the themes identified and outcomes of the qualitative research will be reviewed with the interviewed clinicians. This will attempt to address researcher bias and ensure that participants recognise the issues raised by the research.

Conditions
Chronic Pain
Being tested
Immersive Virtual Reality
Keywords
Virtual Reality
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive Virtual RealityDevice

    Immersive virtual reality games and mindfulness in Oculus Quest Virtual Reality headset

Study groups in NCT04259957
Study groupRoleWhat they receive
Clinician using Virtual Reality in Pain Management ProgramClinicians who have used immersive virtual reality as part of Pain Management program group.
Receives: Device: Immersive Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Semi-structured interview Qualitative interview

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study startApr 2020 (estimated)
  3. Primary completionApr 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259957
Sponsor's protocol ID
01
Status last verified
Feb 2020
First submitted
5 Feb 2020
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain, run by InHealth Group at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas PH Shelton, MSc (07828439152, tom.shelton@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semi-structured interview Qualitative interview (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.

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