Does a pain management programme impact on patients quality of sleep?
| ISRCTN | ISRCTN74913595 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74913595 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/08/2010
- Registration date
- 13/09/2010
- Last edited
- 18/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brona Fullen
Scientific
Scientific
School of Public Health, Physiotherapy and Population Science
Health Science Centre
Belfield Campus
University College Dublin
Dublin
4
Ireland
| Phone | +353 (0)1 716 6516 |
|---|---|
| brona.fullen@ucd.ie |
Study information
| Study design | Clinically wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cognitive behavioural pain management programmes: impact on sleep quality in patients with chronic pain |
| Study objectives | 1. That a cognitive behavioural pain management pain management programme will have long term positive effects on subjective and objective sleep quality in patients with chronic pain by comparison with a control group 2. To investigate the relationship between objective and subjective sleep quality and physical and psychological outcome measures |
| Ethics approval(s) | St James/Adelaide and Meath Hospitals Research Ethics Committee approved in October 2008 |
| Health condition(s) or problem(s) studied | Chronic non-malignant pain |
| Intervention | Cognitive Behavioural Pain Management Programme (CBT-PMP): A multi-disciplinary CBT-PMP provides the patient with multiple therapies involving comprehensive rehabilitation in each of the specialised areas. The core multi-disciplinary team includes a pain management physician, an occupational therapist, a physiotherapist and a clinical psychologist. They identify and change unhelpful thoughts and beliefs, promote relaxation, and help to change habits that contribute to disability. The multi-disciplinary team focuses on specific achievable goals established between the individual therapist and the patient. Participants are advised to practice the skills they have learned both at home, and in other environments, integrating them into their everyday lives in order to help them to manage their pain more effectively. Participants will attend three days a week for four consecutive weeks (10 am - 4 pm). The programme includes daily two-hour group sessions with physiotherapy (stretching programme, core-stability strengthening programme, paced individual exercise on a range of gym equipment, and functional restoration), occupational therapy (improving occupational function and environmental adaptation), and clinical psychology (cognitive behavioural therapy, relaxation techniques). Weekly education sessions with the Pain consultant are also held. Control group: The control group were taken from the waiting list for the cognitive behavioural pain management programme. Both arms of the trial were assessed at baseline; the intervention group were re-assessed on completion of the 4-week pain management programme and again 2 months later. The waiting list control group were reassessed after three months. |
| Intervention type | Other |
| Primary outcome measure | Patients and controls will be assessed one week prior to the commencement of the CBT-PMP, 4 weeks later on completion of the CBT-PMP (or usual care), and two months later: 1. Sleep: 1.1. Objective: Patients will be instructed to wear the Actiwatch (AW4, CamTech, Cambridge, UK) for 7 days (24 hours a day) 1.2. Self-report: Pittsburgh Sleep diary (PghSD) for 7 days 2. Physical Function (objective): The Simmond's functional assessment battery of tests 3. Pain (self-report): Numerical rating scale for current pain, pain at worst/best in last 7 days 4. Psychosocial beliefs (self-report): Tampa Scale of Kinesophobia (fear of re-injury), Hospital Anxiety and Depression Questionnaire 5. Health-related Quality of Life and function (self-report): 36-item short form health survey (SF-36) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 02/02/2009 |
| Completion date | 22/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Patients aged over 18 years, either sex 2. Patients with a diagnosis of chronic pain (pain greater than 6 months) 3. Patients who fulfil the criteria for the Adelaide and Meath Hospitals incorporating the National Children's Hospital (AMNCH) cognitive behavioural pain management programme (CBT-PMP) as per the multidisciplinary team 4. Patients willing to take part in the study 5. Patients who are suffering from sleep disturbance due to pain as determined by the Pittsburgh Sleep Quality Index questionnaire (a score greater than 5 indicating sleep disturbance) |
| Key exclusion criteria | 1. Patients under 18 years 2. Patients who do not have a diagnosis of pain greater than 6 months duration 3. Deemed unsuitable for the AMNCH CBT-PMP as per the multidisciplinary pain team 4. Unwilling to take part in the study 5. Do not suffer from sleep disturbance due to pain as determined by the Pittsburgh Sleep Quality Index questionnaire (a score greater than 5 indicating sleep disturbance) 6. Pregnancy |
| Date of first enrolment | 02/02/2009 |
| Date of final enrolment | 22/05/2010 |
Locations
Countries of recruitment
- Ireland
Study participating centre
School of Public Health, Physiotherapy and Population Science
Dublin
4
Ireland
4
Ireland
Sponsor information
Pfizer Healthcare Ireland (PHI) (Ireland)
Industry
Industry
9, Riverwalk
National Digital Park
Citywest Business Campus
Dublin
24
Ireland
| Website | http://www.pfizer.ie |
|---|---|
"ROR" |
https://ror.org/05y381977 |
Funders
Funder type
Industry
Pfizer Healthcare Ireland (PHI) (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/01/2011 | 18/12/2020 | Yes | No |
Editorial Notes
18/12/2020: Publication reference added.
