search
Back to results

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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Autonomy-supportive counselling (GSD)
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Supportive care, Psychosocial Circumstances, Autonomy support, Nursing intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Autonomy-supportive counselling (GSD)

Arm Description

Standard of care

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.

Outcomes

Primary Outcome Measures

Changes in self-reported life quality
Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire

Secondary Outcome Measures

Changes in self-assessed motivation for pain management
Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire
Changes in self-assessed competence in pain management
Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire

Full Information

First Posted
March 3, 2014
Last Updated
July 9, 2017
Sponsor
Herlev Hospital
Collaborators
Naestved Hospital, Zealand University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02084459
Brief Title
Guided Self-determination in the Treatment of Chronic Pain to Promote the Life Skills of the Patient
Acronym
GSD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
Collaborators
Naestved Hospital, Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Supportive care, Psychosocial Circumstances, Autonomy support, Nursing intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Autonomy-supportive counselling (GSD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Autonomy-supportive counselling (GSD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in self-reported life quality
Description
Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire
Time Frame
Baseline, 2, 6 months
Secondary Outcome Measure Information:
Title
Changes in self-assessed motivation for pain management
Description
Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire
Time Frame
Baseline, 2, 6 months
Title
Changes in self-assessed competence in pain management
Description
Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire
Time Frame
Baseline, 2, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Husum, RN
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niels-Henrik Jensen, MD
Organizational Affiliation
Herlev Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
State/Province
Danmark
ZIP/Postal Code
DK-2730
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34333889
Citation
Pickering AP, Bache NJ, Estrup S. Guided self-determination in treatment of chronic pain - a randomized, controlled trial. Scand J Pain. 2021 Jul 31;22(2):288-297. doi: 10.1515/sjpain-2021-0007. Print 2022 Apr 26.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs