Overview

This trial is active, not recruiting.

Conditions postoperative pain, chronic pain
Treatment psychoeducational
Sponsor Oslo and Akershus University College of Applied Sciences
Collaborator Oslo University Hospital
Start date May 2012
End date October 2015
Trial size 200 participants
Trial identifier NCT01595035, 2011/1984

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Experimental)
Patients who receive the Pain booklet and support by telephone
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
(No Intervention)
Standard care

Primary Outcomes

Measure
Average pain intensity
time frame: 1 week

Secondary Outcomes

Measure
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
Pain occurence
time frame: 3 and 6 month after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Principal investigator Berit Valeberg, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Oslo and Akershus University College of Applied Sciences.