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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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.

Condition Intervention
Postoperative Pain
Chronic Pain
Behavioral: psychoeducational

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery

Resource links provided by NLM:


Further study details as provided by Oslo University College:

Primary Outcome Measures:
  • Average pain intensity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Brief Pain Inventory


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 360
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: counceling
Patients who receive the Pain booklet and support by telephone
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
No Intervention: Control
Standard care
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595035

Contacts
Contact: Berit Taraldsen Valeberg, PhD +4722453835 berit.valeberg@hioa.no
Contact: Tone Rustoen, PhD tone.rustoen@rr-research.no

Sponsors and Collaborators
Oslo University College
Oslo University Hospital
Lovisenberg Diakonale Hospital
Helse Stavanger HF
Investigators
Principal Investigator: Inger Johanne Flatland Oslo and Akershus College
  More Information

No publications provided

Responsible Party: Inger Johanne Flatland, Research Councellor, Oslo University College
ClinicalTrials.gov Identifier: NCT01595035     History of Changes
Other Study ID Numbers: 2012daypain
Study First Received: May 7, 2012
Last Updated: May 8, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University College:
Day surgery
Orthopedic surgery
Breast reconstruction surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014