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

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: Chronic Pain
• Intervention / Treatment: Behavioral: Autonomy-supportive counselling (GSD)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: Chronic pain; Supportive care; Nursing intervention; Psychosocial Circumstances; Autonomy support
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: HEH201300702085