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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 : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):

Study Description
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.


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
Postoperative Pain Chronic Pain Behavioral: psychoeducational

Study Design

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
Primary Completion Date : October 2015
Estimated Study Completion Date : December 2018
Arms and Interventions

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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
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
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

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
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms