Evaluation of an intervention to improve post-operative sleep and pain control in orthopaedic patients at night.
| ISRCTN | ISRCTN53142541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53142541 |
| Protocol serial number | 9502049 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Closs
Scientific
Scientific
School of Healthcare Studies
University of Leeds
22 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
| Phone | +44 (0)113 233 6773 |
|---|---|
| s.j.closs@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Post-operative pain control has frequently been shown to be poor in British hospitals. The particular problems of assessing and controlling pain at night have been neglected. This study aims to evaluate the effectiveness of a two pronged intervention. The first part will consist of a patient education package designed to inform patients about what to expect concerning their pain and its management, and to improve their willingness to report post-operative pain at night. The second will introduce to nurses a method for assessing pain at night. Orthopaedic patients from two wards will be invited to participate. After a period of baseline data collection the intervention will be introduced to one of the wards (assigned randomly), and its effectiveness evaluated. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Post operative pain |
| Intervention | 1. Patient education package designed to inform patients about what to expect concerning their pain and its management, and to improve their willingness to report post-operative pain at night. 2. The second will introduce to nurses a method for assessing pain at night. |
| Intervention type | Other |
| Primary outcome measure(s) |
Outcomes of night-time pain control will be elicited from patients using verbal rating scales, reports of sleep and analgesic provision. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 417 |
| Key inclusion criteria | 1. Two matched orthopaedic wards at a large teaching hospital 2. Elective and trauma patients 3. Aged 18+ years |
| Key exclusion criteria | 1. Permanent night-shift workers 2. Suffering concomitant terminal disease 3. Confused or cognitively impaired |
| Date of first enrolment | 09/01/1995 |
| Date of final enrolment | 31/10/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Healthcare Studies
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/1999 | Yes | No | |
| Other publications | secondary analysis | 01/12/1999 | Yes | No |
