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

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ClinicalTrials.gov Identifier: NCT01595035
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : March 2, 2021
Sponsor:
Collaborators:
Oslo University Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Oslo Metropolitan University

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date March 2, 2021
Study Start Date  ICMJE May 2012
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Average pain intensity [ Time Frame: 1 week ]
Brief Pain Inventory
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • 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 ]
    Brief Pain Inventory
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Official Title  ICMJE A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Postoperative Pain
  • Chronic Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: counselling
    Patients who receive the Pain booklet and support by telephone
    Intervention: Behavioral: psychoeducational
  • No Intervention: Control
    Standard care
Publications * Valeberg BT, Dihle A, Småstuen MC, Endresen AO, Rustøen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Jan 12. doi: 10.1111/jocn.15659. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2016)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
360
Actual Study Completion Date  ICMJE February 2021
Actual Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595035
Other Study ID Numbers  ICMJE 2011/1984
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo Metropolitan University
Study Sponsor  ICMJE Oslo Metropolitan University
Collaborators  ICMJE
  • Oslo University Hospital
  • Helse Stavanger HF
Investigators  ICMJE
Principal Investigator: Berit Valeberg, PhD Oslo Metropolitan University
PRS Account Oslo Metropolitan University
Verification Date February 2021

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