About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
ROHKEA: Virtual Reality Therapy
DeviceUsing 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
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
Secondary outcomes
Brief Pain Inventory (BPI)
measures pain severity, the impact of pain on daily function, the location of pain, pain medications and amount of pain relief in the past 24 hours of past week. There is no scoring algorithm for the Brief Pain Inventory, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Chronic pain acceptance questionnaire
short version 8 (CPAQ8) to identify different profiles of pain acceptance patterns, levels of function and behavioural flexibility.A 7-point scale from 0 (never true) to 6 (always true). To score add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Higher scores indicate higher levels of acceptance
Patient Health Questionnaire
short version 4 (PHQ4). Four questions answered on a four point Likert-type scale. Its purpose is to allow for ultra-brief and accurate measurement of core symptoms/signs of depression and anxiety.
Sponsors and contacts
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Torbay and South Devon NHS Foundation Trust
Lead sponsor
Torbay Hospital
Collaborator
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