NCT02084459

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

March 3, 2014

Last Update Submit

July 9, 2017

Conditions

Chronic Pain

Keywords

Chronic painSupportive carePsychosocial CircumstancesAutonomy supportNursing intervention

Outcome Measures

Primary Outcomes (1)

  • Changes in self-reported life quality

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

    Baseline, 2, 6 months

Secondary Outcomes (2)

  • Changes in self-assessed motivation for pain management

    Baseline, 2, 6 months

  • Changes in self-assessed competence in pain management

    Baseline, 2, 6 months

Study Arms (2)

Control

NO INTERVENTION

Standard of care

Autonomy-supportive counselling (GSD)

EXPERIMENTAL

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)

Interventions

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.

Autonomy-supportive counselling (GSD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older, diagnosed with nonmalignant chronic pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Danmark, DK-2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34333889DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mette Husum, RN

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

  • Niels-Henrik Jensen, MD

    Herlev Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, project leader

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 12, 2014

Study Start

February 1, 2013

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

DK(1)