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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oslo University Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01595035
First received: May 7, 2012
Last updated: January 6, 2016
Last verified: January 2016

May 7, 2012
January 6, 2016
May 2012
October 2015   (final data collection date for primary outcome measure)
Average pain intensity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Brief Pain Inventory
Same as current
Complete list of historical versions of study NCT01595035 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Pain occurence [ Time Frame: 3 and 6 month after surgery ] [ Designated as safety issue: No ]
    Brief Pain Inventory
Same as current
Not Provided
Not Provided
 
A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Postoperative Pain
  • Chronic Pain
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
  • Experimental: counselling
    Patients who receive the Pain booklet and support by telephone
    Intervention: Behavioral: psychoeducational
  • No Intervention: Control
    Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2018
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01595035
2011/1984
No
Not Provided
Not Provided
Oslo and Akershus University College of Applied Sciences
Oslo and Akershus University College of Applied Sciences
  • Oslo University Hospital
  • Helse Stavanger HF
Principal Investigator: Berit Valeberg, PhD Oslo and Akershus University College of Applied Sciences
Oslo and Akershus University College of Applied Sciences
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP