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Completed

NCT Number: NCT01595035

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo and Akershus University College of Apllied Sciences

Oslo, N-0130, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Average pain intensity

    Time frame: 1 week

    Brief Pain Inventory

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Helse Stavanger HF
  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2021
First posted
May 9, 2012
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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