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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Pain, Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: psychoeducational


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: counselling<br>Patients who receive the Pain booklet and support by telephone | Behavioral: psychoeducational<br>* 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<br>|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain intensity | Brief Pain Inventory | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain occurence | Brief Pain Inventory | 3 and 6 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Day surgery, Orthopedic surgery, Breast reconstruction surgery