Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jose Closs

ORCID ID

Contact details

School of Healthcare Studies
University of Leeds
22 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
+44 (0)113 233 6773
s.j.closs@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9502049

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

09/01/1995

Overall trial end date

31/10/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Two matched orthopaedic wards at a large teaching hospital
2. Elective and trauma patients
3. Aged 18+ years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

417 (added 21/01/10; see publication)

Participant exclusion criteria

1. Permanent night-shift workers
2. Suffering concomitant terminal disease
3. Confused or cognitively impaired

Recruitment start date

09/01/1995

Recruitment end date

31/10/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Healthcare Studies
Leeds
LS2 9LN
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10375063
2. 1999 secondary analysis in http://www.ncbi.nlm.nih.gov/pubmed/10641470

Publication citations

  1. Results

    Closs SJ, Briggs M, Everitt VE, Implementation of research findings to reduce postoperative pain at night., Int J Nurs Stud, 1999, 36, 1, 21-31.

  2. Secondary analysis

    Briggs M, Closs JS, A descriptive study of the use of visual analogue scales and verbal rating scales for the assessment of postoperative pain in orthopedic patients., J Pain Symptom Manage, 1999, 18, 6, 438-446.

Additional files

Editorial Notes