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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595035
• Other study ID #: 2011/1984
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: February 2021

Study information

• Verified date: February 2021
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Postoperative Pain

Intervention

Behavioral:
• psychoeducational
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

Locations

Country	Name	City	State
Norway	Oslo and Akershus University College of Apllied Sciences	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Helse Stavanger HF, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average pain intensity	Brief Pain Inventory	1 week
Secondary	The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.		1,2,3,7 day after surgery
Secondary	Pain occurence	Brief Pain Inventory	3 and 6 month after surgery