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

NCT01595035 | Completed

• 1 other identifier: 2011/1984
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Chronic Pain

Keywords

Day surgery; Orthopedic surgery; Breast reconstruction surgery

Outcome Measures

Primary Outcomes (1)

• Average pain intensity

  Brief Pain Inventory

  1 week

Secondary Outcomes (2)

• The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.

  1,2,3,7 day after surgery

• Pain occurence

  3 and 6 month after surgery

Study Arms (2)

counselling

EXPERIMENTAL

Patients who receive the Pain booklet and support by telephone

Behavioral: psychoeducational

Control

NO INTERVENTION

Standard care

Interventions

psychoeducational BEHAVIORAL

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

counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• Staying overnight in hospital

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator
• Helse Stavanger HF: collaborator

Study Sites (1)

Oslo and Akershus University College of Apllied Sciences

Oslo, N-0130, Norway

Location

Related Publications (1)

• Valeberg BT, Dihle A, Smastuen MC, Endresen AO, Rustoen T. The effects of a psycho-educational intervention to improve pain management after day surgery: A randomised clinical trial. J Clin Nurs. 2021 Apr;30(7-8):1132-1143. doi: 10.1111/jocn.15659. Epub 2021 Jan 25.

  PMID: 33432643 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berit Valeberg, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

NO (1)