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Completed

NCT Number: NCT02084459

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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital

Herlev, Danmark, DK-2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autonomy-supportive counselling (GSD)

Behavioral

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 outcomes

  1. Changes in self-reported life quality

    Time frame: Baseline, 2, 6 months

    Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire

Secondary outcomes

  1. Changes in self-assessed motivation for pain management

    Time frame: Baseline, 2, 6 months

    Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire

  2. Changes in self-assessed competence in pain management

    Time frame: Baseline, 2, 6 months

    Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Naestved Hospital
  • Zealand University Hospital

Registry information

Official study 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

Acronym: GSD

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 12, 2014
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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