Clinical trial NCT01595035: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Chronic Pain
Keywords: Day surgery
Orthopedic surgery
Breast reconstruction surgery
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Helse Stavanger HF
First posted: 2012-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Average pain intensity
timeFrame: 1 week
Secondary outcomes:
measure: The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
timeFrame: 1,2,3,7 day after surgery
measure: Pain occurence
timeFrame: 3 and 6 month after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo and Akershus University College of Apllied Sciences
Study officials:
affiliation: Oslo Metropolitan University
name: Berit Valeberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.