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

This study is not yet open for participant recruitment.
Verified May 2012 by Oslo University College
Sponsor:
Collaborators:
Oslo University Hospital
Lovisenberg Diakonale Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Inger Johanne Flatland, Oslo University College
ClinicalTrials.gov Identifier:
NCT01595035
First received: May 7, 2012
Last updated: May 8, 2012
Last verified: May 2012

May 7, 2012
May 8, 2012
May 2012
December 2012   (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: counceling
    Patients who receive the Pain booklet and support by telephone
    Intervention: Behavioral: psychoeducational
  • No Intervention: Control
    Standard care
    Intervention: Behavioral: psychoeducational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
360
December 2014
December 2012   (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
No
Contact: Berit Taraldsen Valeberg, PhD +4722453835 berit.valeberg@hioa.no
Contact: Tone Rustoen, PhD tone.rustoen@rr-research.no
Not Provided
 
NCT01595035
2012daypain
No
Inger Johanne Flatland, Oslo University College
Oslo University College
  • Oslo University Hospital
  • Lovisenberg Diakonale Hospital
  • Helse Stavanger HF
Principal Investigator: Inger Johanne Flatland Oslo and Akershus College
Oslo University College
May 2012

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