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
  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 and Akershus University College of Applied Sciences:

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


Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: counselling
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
Norway
Oslo and Akershus University College of Apllied Sciences
Oslo, Norway, N-0130
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Oslo University Hospital
Helse Stavanger HF
Investigators
Principal Investigator: Berit Valeberg, PhD Oslo and Akershus University College of Applied Sciences
  More Information

Responsible Party: Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT01595035     History of Changes
Other Study ID Numbers: 2011/1984 
Study First Received: May 7, 2012
Last Updated: January 6, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo and Akershus University College of Applied Sciences:
Day surgery
Orthopedic surgery
Breast reconstruction surgery

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 30, 2016