ROHKEA: Virtual Reality Therapy 12-week Programme for Chronic Pain

NCT06756464 | Not Yet Recruiting

• 1 other identifier: 330581
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

One in four people experience low back pain. 20% of adults suffer with chronic pain, with less than 1% having access to pain management services. Torbay has the highest under 75 years mortality rate in the South West, UK, and chronic pain can account for an increase in mortality by 10 years. Pain Management is seen as a luxury good, and scalable solutions are needed. Using Virtual Reality therapies in the patient's own home, will provide a therapeutic bridge to assist their transition back into richer, and more meaningful lives, despite pain. Virtual reality therapy can offer a 'dress-rehearsal' - to practise Cognitive Behavioural Therapy and movement skills, to support patients to have the courage to leave their homes and step into 'real-life'. It is also of benefit as it fits in with the participants who have other commitments eg work, looking after a relative or other dependents, school run, etc which makes it impossible to access standard treatment as usual. We aim to explore the experiences of 6 patients during their journey through a 12-week pain management programme delivered using Virtual reality and facilitated by a semi-automated mentoring device (SAMI). An Interpretative Phemenological Analysis design will be utilised using semi-structured interviews. The verbatim transcripts of those interviews will be used as the data. Participants will be asked to keep a rolling diary of their experience across the 12-week programme - and to re-read this prior to the interview at the end. Participants will be recruited via the clinical pain rehabilitation team. They will complete a telephone triage and a VR screening tool. Participants will be interviewed 1-2 weeks post completing the programme. The session will be recorded and a transcript generated. Participant characteristics and chronicity of pain will be noted. Themes will be generated from the transcripts, and connections will be sought.

Conditions

Musculoskeletal

Keywords

virtual reality; chronic pain

Outcome Measures

Primary Outcomes (2)

• Participants acceptance and experiences of using a virtual reality therapy 12-week pain management programme

  Semi structured interviews to assess user acceptance of the VR equipment (motion sickness, comfort of the headset); the 60 day chronic pain management programme compliance rates (adherence to daily practice, home practice and user engagement with the mobile app).

  1-2 weeks post completing the 12 week programme

• Participants acceptance and experiences of using a virtual reality therapy 12-week pain management programme

  Patient diaries - to assess user acceptance of the VR equipment (motion sickness, comfort of the headset); the 60 day chronic pain management programme compliance rates (adherence to daily practice, home practice and user engagement with the mobile app).

  12 weeks

Secondary Outcomes (3)

• Brief Pain Inventory (BPI)

  completed at assessment, pre and post the 12-week programme

• Chronic pain acceptance questionnaire

  completed at assessment, pre and post the 12-week programme

• Patient Health Questionnaire

  completed at assessment, pre and post the 12-week programme

Study Arms (1)

ROHKEA: VR therapy

EXPERIMENTAL

This is a pilot/feasibility study using an Interpretative Phenomenological Analysis (IPA) design and semi-structured interviews: to explore the experience of 6 patients with chronic pain going through a VR enhanced CBT and graded exposure 12-week chronic pain management programme.

Device: ROHKEA: Virtual Reality Therapy

Interventions

ROHKEA: Virtual Reality Therapy DEVICE

Using Interpretative Phenomenological Analysis (IPA): an exploration of the therapeutic benefits of a Virtual Reality enhanced Cognitive Behavioural Therapy (CBT) and movement (graded exposure) therapy 60-day chronic pain management programme (CPMP). Using the ROHKAE device and undertaking semi structures interviews, pain questionnaires and patient diaries to measure patient experience and pain management

ROHKEA: VR therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-99 years old
• Willing and able to give informed consent
• Experience chronic pain (minimum pain chronicity 3 months)
• Able to use Virtual Reality equipment and satisfy the VR screening form stipulations
• Have access to a smart phone (as need to use the mobile APP) and wifi
• Willing to commit to up to 30minutes home practice a day
• Willing to learn new skills and adopt a self management approach to manage their pain

You may not qualify if:

• Anyone aged less than 18years or over 99 years old
• Unwilling and unable to give informed consent
• Pain less than 3 months
• Unable to use Virtual Reality equipment and do not satisfy the VR screening form stipulations
• Do not have access to a smart phone or wifi
• Are unwilling to commit to up to 30 minutes home practice each day
• Unwilling to learn new skills and adopt a self management approach to manage their pain

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust: lead
• Torbay Hospital: collaborator

Study Sites (1)

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phillipa Newton Cross

  Torbay and South Devon NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phillipa Newton-Cross

CONTACT

44 1803614567; phillipa.newton-cross@nhs.net

Fiona Roberts

CONTACT

44 1803 656635; fiona.roberts34@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12 week virtual reality (VR) enhanced cognitive behavioural therapy (CBT) programme for chronic pain

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)