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

Chronic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084459
• Other study ID #: HEH201300702085
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: July 9, 2017
• Start date: February 2013
• Est. completion date: July 15, 2016

Study information

• Verified date: July 2017
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
Herlev Hospital	Naestved Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in self-reported life quality	Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire	Baseline, 2, 6 months
Secondary	Changes in self-assessed motivation for pain management	Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire	Baseline, 2, 6 months
Secondary	Changes in self-assessed competence in pain management	Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire	Baseline, 2, 6 months