Chronic PainGSDNCT02084459
Guided Self-determination in the Treatment of Chronic Pain to Promote the Life Skills of the Patient
A study testing Autonomy-supportive counselling (GSD) in people with Chronic Pain, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Autonomy-supportive counselling (GSD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to 15 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older, diagnosed with nonmalignant chronic pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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".
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Autonomy-supportive counselling (GSD)
- Keywords
- Chronic pain, Supportive care, Psychosocial Circumstances, Autonomy support, Nursing intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomy-supportive counselling (GSD)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Autonomy-supportive counselling (GSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported life quality
Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire
Measured: Baseline, 2, 6 months
Secondary outcomes (2)
Changes in self-assessed motivation for pain management
Measured by the self-rating "PAM (Patient Activation Measure)"-questionnaire
Measured: Baseline, 2, 6 months
Changes in self-assessed competence in pain management
Measured by the self-rating "SOC (Sense of Coherence)" - questionnaire
Measured: Baseline, 2, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital, Zealand University Hospital
- Responsible party
- Principal investigator, Anne Pickering, Herlev Hospital
- Investigators
- Mette Husum, RN, Principal investigator, Herlev HospitalNiels-Henrik Jensen, MD, Study chair, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084459
- Sponsor's protocol ID
- HEH201300702085
- Acronym
- GSD
- Status last verified
- Jul 2017
- First submitted
- 3 Mar 2014
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34333889
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02084459
- Acronym / sponsor ID
- GSD / HEH201300702085
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Supportive care, Psychosocial Circumstances, Autonomy support, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Naestved Hospital, Zealand University Hospital
- Study start
- Feb 2013
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Autonomy-supportive counselling (GSD) | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years and older, diagnosed with nonmalignant chronic pain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Autonomy-supportive counselling (GSD) |
Primary outcome
Changes in self-reported life quality
Time frame: Baseline, 2, 6 months
Measured by the self-rating "SF-36 (Short-form 36)" - questionnaire
2 secondary outcomes
Changes in self-assessed motivation for pain management
Time frame: Baseline, 2, 6 months
Changes in self-assessed competence in pain management
Time frame: Baseline, 2, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Derived from this study: PubMed 34333889Pickering 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Husum, RN principal investigator
Herlev Hospital
Niels-Henrik Jensen, MD study chair
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autonomy-supportive counselling (GSD) in people with Chronic Pain, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported life quality (time frame: Baseline, 2, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.