Guided Self-determination in the Treatment of Chronic Pain to Promote the Life Skills of the Patient (GSD)

July 9, 2017 updated by: Anne Pickering, Herlev Hospital

The Use of Guided Self-determination in the Treatment of Chronic Pain Patients Will Increase Life Skills and Thereby Life Quality of the Chronic Pain Patient

The purpose of this randomized study is to find out whether using the Danish-developed nursing intervention guided self-determination (GSD) can improve life skills of the chronic pain patient.

The hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twenty percent of the Danish population suffer from chronic pain, which leads to the second highest financial expense following psychiatric diseases. In treating chronic pain, the main focus is often on diagnosis and treatment rather than life quality and everyday life. Several studies point to the fact that the interaction between the health professional and the patient can be improved by the individual patient being educated in taking responsibility for his/her own illness, and by involving the patient in decision making through training communication.

GSD is an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses.

A total of 192 patients will be included and randomized in either an intervention or in a control group. The difference between the two groups is measured by means of three questionnaires, SF-36, PAM and SOC, which are answered before and after the intervention as well as 6 months later.

The hypothesis is "using guided self-determination in the treatment of chronic pain patients will increase the life skills of the patients and thus their life quality in spite of pain".

An alliance is established between The Multidisciplinary Pain Clinic at Herlev Hospital and The Pain Clinic at Naestved Hospital as well as The Regional Pain Clinic at Koege Hospital to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Herlev, Danmark, Denmark, DK-2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older, diagnosed with nonmalignant chronic pain

Exclusion Criteria:

  • patients who do not read, write and understand the Danish language
  • patients with a known medical abuse
  • patients needing special psychological and/or psychiatric intervention
  • patients with health-related problems preventing them from participating in a group

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Standard of care
EXPERIMENTAL: Autonomy-supportive counselling (GSD)
GSD, an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses.
Behavioral: Autonomy-supportive counselling (GSD)
GSD, an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-reported life quality
Time Frame: Baseline, 2, 6 months
Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire
Baseline, 2, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-assessed motivation for pain management
Time Frame: Baseline, 2, 6 months
Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire
Baseline, 2, 6 months
Changes in self-assessed competence in pain management
Time Frame: Baseline, 2, 6 months
Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire
Baseline, 2, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

Zealand University Hospital
Naestved Hospital

Investigators

  • Principal Investigator: Mette Husum, RN, Herlev Hospital
  • Study Chair: Niels-Henrik Jensen, MD, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

July 15, 2016

Study Completion (ACTUAL)

July 15, 2016

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (ESTIMATE)

March 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 9, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEH201300702085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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