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

This study is not yet open for participant recruitment.

Verified May 2012 by Oslo University College

Sponsor:

Collaborators:

Oslo University Hospital

Lovisenberg Diakonale Hospital

Helse Stavanger HF

Information provided by (Responsible Party):

Inger Johanne Flatland, Oslo University College

ClinicalTrials.gov Identifier:

NCT01595035

First received: May 7, 2012

Last updated: May 8, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2012

Last Updated Date

May 8, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Average pain intensity [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Brief Pain Inventory

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01595035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Pain occurence [ Time Frame: 3 and 6 month after surgery ] [ Designated as safety issue: No ]
Brief Pain Inventory

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care

Condition ^ICMJE

Postoperative Pain
Chronic Pain

Intervention ^ICMJE

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 Arm (s)

Experimental: counceling
Patients who receive the Pain booklet and support by telephone

Intervention: Behavioral: psychoeducational
No Intervention: Control
Standard care

Intervention: Behavioral: psychoeducational

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

360

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Berit Taraldsen Valeberg, PhD	+4722453835	berit.valeberg@hioa.no
Contact: Tone Rustoen, PhD		tone.rustoen@rr-research.no

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01595035

Other Study ID Numbers ^ICMJE

2012daypain

Has Data Monitoring Committee

Responsible Party

Inger Johanne Flatland, Oslo University College

Study Sponsor ^ICMJE

Oslo University College

Collaborators ^ICMJE

Oslo University Hospital
Lovisenberg Diakonale Hospital
Helse Stavanger HF

Investigators ^ICMJE

Principal Investigator:

Inger Johanne Flatland

Oslo and Akershus College

Information Provided By

Oslo University College

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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