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A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery

Primary Purpose

Postoperative Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
psychoeducational
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Day surgery, Orthopedic surgery, Breast reconstruction surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years of age;
  • able, to read, write, and understand Norwegian;
  • are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and
  • have a telephone line.

Exclusion Criteria:

  • Staying overnight in hospital

Sites / Locations

  • Oslo and Akershus University College of Apllied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

counselling

Control

Arm Description

Patients who receive the Pain booklet and support by telephone

Standard care

Outcomes

Primary Outcome Measures

Average pain intensity
Brief Pain Inventory

Secondary Outcome Measures

The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
Pain occurence
Brief Pain Inventory

Full Information

First Posted
May 7, 2012
Last Updated
March 1, 2021
Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital, Helse Stavanger HF
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1. Study Identification

Unique Protocol Identification Number
NCT01595035
Brief Title
A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Official Title
A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital, Helse Stavanger HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. The aim of this study is to enhance pain management by academic detailing (patients' current knowledge and motivations are the basis for information) and nurse coaching (frequent and individualized support). The study consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by a structured telephone interview; (2) development of an intervention to improve pain management; (3) implement and evaluate the intervention; (4) evaluate the incidence of chronic pain after day surgery. Even if patients are prescribed sufficient doses of analgesics, pain relief is dependent on patients' adherence with the analgesic regimen. Psychological factors, such as catastrophizing may also contribute to patients' experience of postoperative pain. Strategies that may be more effective than general information concerning surgery and pain management is academic detailing and nurse coaching, and will be used as frame for the intervention. Hypothesis: Over the seven days after surgery patients in the intervention group report; higher adherence with the analgesic regimen, have less pain intensity and pain interference with function and lower severity of side effects compared to the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Chronic Pain
Keywords
Day surgery, Orthopedic surgery, Breast reconstruction surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
counselling
Arm Type
Experimental
Arm Description
Patients who receive the Pain booklet and support by telephone
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
psychoeducational
Intervention Description
Patients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management
Primary Outcome Measure Information:
Title
Average pain intensity
Description
Brief Pain Inventory
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
Time Frame
1,2,3,7 day after surgery
Title
Pain occurence
Description
Brief Pain Inventory
Time Frame
3 and 6 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years of age; able, to read, write, and understand Norwegian; are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and have a telephone line. Exclusion Criteria: Staying overnight in hospital
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Valeberg, PhD
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo and Akershus University College of Apllied Sciences
City
Oslo
ZIP/Postal Code
N-0130
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
33432643
Citation
Valeberg BT, Dihle A, Smastuen MC, Endresen AO, Rustoen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Apr;30(7-8):1132-1143. doi: 10.1111/jocn.15659. Epub 2021 Jan 25.
Results Reference
derived

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A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery

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