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

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

Tracking Information

• First Submitted Date: May 7, 2012
• First Posted Date: May 9, 2012
• Last Update Posted Date: March 2, 2021
• Study Start Date: May 2012
• Actual Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2012)

Average pain intensity [ Time Frame: 1 week ]

Brief Pain Inventory

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care

Condition

• Postoperative Pain
• Chronic Pain

Intervention

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

• 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]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 6, 2016): 200
• Original Estimated Enrollment (submitted: May 8, 2012): 360
• Actual Study Completion Date: February 2021
• Actual Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT01595035
• Other Study ID Numbers: 2011/1984
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Oslo Metropolitan University
• Study Sponsor: Oslo Metropolitan University

Collaborators

• Oslo University Hospital
• Helse Stavanger HF

Investigators

• Principal Investigator: Berit Valeberg, PhD; Oslo Metropolitan University

• PRS Account: Oslo Metropolitan University
• Verification Date: February 2021