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
Secondary identifying numbers	9502049

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

School of Healthcare Studies
University of Leeds
22 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Phone	+44 (0)113 233 6773
Email	s.j.closs@leeds.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
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	Outcomes of night-time pain control will be elicited from patients using verbal rating scales, reports of sleep and analgesic provision.
Secondary outcome measures	Not provided at time of registration
Overall study start date	09/01/1995
Completion date	31/10/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	417 (added 21/01/10; see publication)
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

England
United Kingdom

Study participating centre

School of Healthcare Studies

Leeds
LS2 9LN
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

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?
Results article	results	01/02/1999		Yes	No
Other publications	secondary analysis	01/12/1999		Yes	No