Clinical trial NCT02084459: Guided Self-determination in the Treatment of Chronic Pain to Promote the Life Skills of the Patient
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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Supportive care
Psychosocial Circumstances
Autonomy support
Nursing intervention
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Naestved Hospital
name: Zealand University Hospital
First posted: 2014-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in self-reported life quality
timeFrame: Baseline, 2, 6 months
Secondary outcomes:
measure: Changes in self-assessed motivation for pain management
timeFrame: Baseline, 2, 6 months
measure: Changes in self-assessed competence in pain management
timeFrame: Baseline, 2, 6 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Danmark
Study officials:
affiliation: Herlev Hospital
name: Mette Husum, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Niels-Henrik Jensen, MD
role: STUDY_CHAIR
References:
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.