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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Herlev Hospital
Sponsor:
Collaborators:
Naestved Hospital
Koege Sygehus
Information provided by (Responsible Party):
Anne Paarup Pickering, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT02084459
First received: March 3, 2014
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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".


Condition Intervention
Chronic Pain
Behavioral: Autonomy-supportive counselling (GSD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Changes in self-reported life quality [ Time Frame: Baseline, 2, 6 months ] [ Designated as safety issue: No ]
    Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire


Secondary Outcome Measures:
  • Changes in self-assessed motivation for pain management [ Time Frame: Baseline, 2, 6 months ] [ Designated as safety issue: No ]
    Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire

  • Changes in self-assessed competence in pain management [ Time Frame: Baseline, 2, 6 months ] [ Designated as safety issue: No ]
    Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire


Estimated Enrollment: 192
Study Start Date: February 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084459

Contacts
Contact: Anne P Pickering, RN +45-56512861 anpp@regionsjaelland.dk
Contact: Nina Bache, RN +45-47326370 njb@regionsjaelland.dk

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Danmark, Denmark, DK-2730
Contact: Anne P Pickering, RN    +45-56512861    anpp@regionsjaelland.dk   
Contact: Nina Bache, RN    +45-47326370    njb@regionsjaelland.dk   
Principal Investigator: Anne P Pickering, RN         
Sponsors and Collaborators
Herlev Hospital
Naestved Hospital
Koege Sygehus
Investigators
Principal Investigator: Niels-Henrik Jensen, MD Herlev Hospital
  More Information

No publications provided

Responsible Party: Anne Paarup Pickering, Nurse, project leader, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02084459     History of Changes
Other Study ID Numbers: HEH201300702085
Study First Received: March 3, 2014
Last Updated: August 8, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Herlev Hospital:
Chronic pain
Supportive care
Psychosocial Circumstances
Autonomy support
Nursing intervention

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014