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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595035
Recruitment Status : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Oslo University Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Oslo Metropolitan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Chronic Pain Behavioral: psychoeducational Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Study Start Date : May 2012
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Average pain intensity [ Time Frame: 1 week ]
    Brief Pain Inventory


Secondary Outcome Measures :
  1. 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 ]
  2. Pain occurence [ Time Frame: 3 and 6 month after surgery ]
    Brief Pain Inventory


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595035


Locations
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Norway
Oslo and Akershus University College of Apllied Sciences
Oslo, Norway, N-0130
Sponsors and Collaborators
Oslo Metropolitan University
Oslo University Hospital
Helse Stavanger HF
Investigators
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Principal Investigator: Berit Valeberg, PhD Oslo Metropolitan University
More Information
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Responsible Party: Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT01595035    
Other Study ID Numbers: 2011/1984
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Keywords provided by Oslo Metropolitan University:
Day surgery
Orthopedic surgery
Breast reconstruction surgery
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations