Fibromyalgia SyndromeNCT06147882
The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome
A study testing The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy. in people with Fibromyalgia Syndrome, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Fibromyalgia (FM) is characterized by symptoms such as chronic widespread pain, severe fatigue, sleep disturbances, extremity paresthesia, stiffness, mood disturbances, and cognitive impairment lasting more than 3 months without an alternative explanation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 21 May 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Having been diagnosed with Fibromyalgia Syndrome according to the 2016 ACR diagnostic criteria for at least 1 year,
- Agreeing to participate in the study.
Who cannot join
- Those in acute depression
- History of a recent cardiac event such as myocardial infarction,
- History of significant head trauma,
- Peripheral neuropathy,
- Use of some centrally acting analgesic drugs such as opioids,
- History of substance and alcohol abuse,
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- Concomitant autoimmune or inflammatory disease,
- Diseases affecting the central nervous system (for example, multiple sclerosis, Parkinson's disease),
- Serious psychiatric conditions that prevent participation (for example, psychotic disorders).
- Previously, therapy, counseling, personal development, etc. to have received
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positive Psychotherapy-based Physicoeducation Program on Pain Perception , Activities of Daily Living, and Mental Health of Patients With Fibromyalgia Syndrome.
Fibromyalgia (FM) is characterized by symptoms such as chronic widespread pain, severe fatigue, sleep disturbances, extremity paresthesia, stiffness, mood disturbances, and cognitive impairment lasting more than 3 months without an alternative explanation. Although the exact etiology and pathogenesis of FM is still unknown, it has been suggested that stress or psychological factors may play a key role in the syndrome. 1,2,3 Positive Psychotherapy supports individuals in symptom management to use their resources to overcome difficulties, understand and recognize growth areas with a therapeutic approach.4 In this respect, it overlaps with the professional purpose of mental health and psychiatric nursing (RSPH). The aim of this study; In this study, it is aimed to report the process of examining the pain perception, daily life activities and mental health of patients with fibromyalgia syndrome (FMS) and the effectiveness of the psychoeducation program based on Positive Psychotherapy (PPT).
Read the detailed description
The research is planned to be carried out between June 2023 and June 2024. The study will be conducted with patients diagnosed with FMS, who applied to a private Medical Center Orthopedics Outpatient Clinic in Düzce. The research was planned as a randomized controlled trial. The sample of the study will consist of patients selected by the randomization selection method who meet the inclusion criteria. The Gpower 3.1 program was used to determine the number of patients in the experimental and control groups of the study. In this context, two-way analysis of variance (TWO-WAY-ANOVA) method will be used. In conditions where the effect level was 0.40 (large effect), the error level (a) was 0.05, and the power of the test (1-B) was 0.95, the minimum sample size required for a statistically significant difference between the groups and between the measurements was obtained as 58. Each group must have at least 29 participants. In studies on the dependent variable in the literature, the drop out rate was found to be 6-12 (10-12%). Therefore, in this study, the drop out rate will be taken as 10, and the sample size will be determined as 34 for each group. The study was planned as 3 stages as randomized controlled pre-test, repeated post-test and 3rd month follow-up test. Within the scope of the study, Introductory Information Form, Visual Analogue Scale (VAS) (will be measured 3 times), Fibromyalgia Impact Questionnaire (FIQ) (will be measured 3 times), General Health Questionnaire-28 (GSA-28) (will be measured 3 times) will be applied. Within the scope of the research, it was planned to apply a PPT-based Psychoeducation Program consisting of 10 sessions, each of 120-90 minutes, to a group of participants diagnosed with FMS. The program to be implemented within the scope of the research was prepared after the literature review and together with the participant's handbook, it was sent to Positive Psychotherapy experts to get expert opinions. After the expert evaluations, necessary arrangements were made and the program was finalized. The applied Positive Psychotherapy group program was developed by the researcher by scanning the literature, the session contents, which blend three basic principles, including the real abilities of PPT, the balance model and the five-step therapy process, in order to minimize the symptoms that limit the daily life activities of FMS patients and create problems in their social lives. Information to be given, practices to be given and homework to be given for each session were determined. The purpose of the sessions was prepared by determining the targets expected to be achieved by the participants at the end of each session.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.Behavioural
The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation Group | Active comparator | The group of patients who are given psychoeducation program Receives: Behavioral: The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy. |
| Control Group | No intervention | The group of patients who are not given psychoeducation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Perception of Fibromyalgia Syndrome Patients from Baseline
Pain will be used to evaluate by VAS (Visual Anolog Scale) Line: A horizontal line is usually used, with the left end representing one extreme (e.g., "no pain" or "not at all") and the right end representing the other extreme (e.g., "worst pain imaginable" or "extremely intense").
Length: The line is typically 100 millimeters long Participants are provided with instructions explaining what the scale measures (e.g., pain intensity) and are asked to mark a point on the line that best represents their experience.
Scoring: Measurement is done by measuring the distance in millimeters from the left end of the line to the point marked by the participant. This provides a numerical score that quantifies the individual's perception.
Interpretation: A higher score on the VAS generally indicates a more intense or severe experience of the measured phenomenon.
Measured: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Change in daily living activities of fibromyalgia patients from baseline
Fibromyalgia Impact Questionnaire The Fibromyalgia Impact Questionnaire (FIQ) is a self-administered questionnaire designed to assess the health status and impact of fibromyalgia on individuals. It was developed to provide a comprehensive overview of the various aspects of fibromyalgia, including physical functioning, symptoms, and overall well-being.
Physical Functioning:
Work Status:
Questions address how fibromyalgia affects an individual's ability to work.
Depression and Anxiety:
The FIQ includes questions about emotional well-being, assessing symptoms of depression and anxiety.
Morning Tiredness:
Measures the level of fatigue and tiredness experienced in the morning, providing insights into the impact of fibromyalgia on sleep and morning functioning.
Pain Levels:
Questions related to the intensity of pain experienced by individuals with fibromyalgia.
Stiffness:
Assesses the extent of stiffness experienced by individuals, which is a common symptom of fibromyalgia.
Measured: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Secondary outcomes (1)
Change in the mental health of fibromyalgia patients from the beginning
General Health Questionnaire-28 General Health Questionnaire -28 is a self-filled screening test designed to detect mental health problems encountered in society and non-psychiatric clinical settings. The survey consists of four subsections, each consisting of seven items. These sections; Somatic symptoms include anxiety and sleep disorders, impairment in social functioning, and major depression. The 28-item scale consists of a question about whether each individual has a recent complaint and a four-item response ranging from "less than usual" to "much more than usual". After the application, a minimum score of 0 and a maximum of 28 points can be obtained, and a higher score increases the likelihood of mental health disorders.
Measured: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jul 2023
- Primary completion12 Jan 2024
- Study completion21 May 2024
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 Fibromyalgia SyndromeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamide Erol, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147882
- Sponsor's protocol ID
- duzceuniversityhamide001
- Status last verified
- Aug 2024
- First submitted
- 6 Oct 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erol H, Karaca A. The Effect of Positive Psychotherapy on Pain Perception, Daily Functioning, and Mental Health in Patients With Fibromyalgia. Pain Manag Nurs. 2025 Dec;26(6):e550-e560. doi: 10.1016/j.pmn.2025.07.007. Epub 2025 Sep 4.
PubMed 40912975
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Psychotherapy-based Physicoeducation Program on Pain Perception , Activities of Daily Living, and Mental Health of Patients With Fibromyalgia Syndrome.
- ClinicalTrials.gov ID
- NCT06147882
- Acronym / sponsor ID
- duzceuniversityhamide001
- Conditions
- Fibromyalgia Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- 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.
Fibromyalgia (FM) is characterized by symptoms such as chronic widespread pain, severe fatigue, sleep disturbances, extremity paresthesia, stiffness, mood disturbances, and cognitive impairment lasting more than 3 months without an alternative explanation. Although the exact etiology and pathogenesis of FM is still unknown, it has been suggested that stress or psychological factors may play a key role in the syndrome. 1,2,3 Positive Psychotherapy supports individuals in symptom management to use their resources to overcome difficulties, understand and recognize growth areas with a therapeutic approach.4 In this respect, it overlaps with the professional purpose of mental health and psychiatric nursing (RSPH). The aim of this study; In this study, it is aimed to report the process of examining the pain perception, daily life activities and mental health of patients with fibromyalgia syndrome (FMS) and the effectiveness of the psychoeducation program based on Positive Psychotherapy (PPT).
Detailed description
The research is planned to be carried out between June 2023 and June 2024. The study will be conducted with patients diagnosed with FMS, who applied to a private Medical Center Orthopedics Outpatient Clinic in Düzce. The research was planned as a randomized controlled trial. The sample of the study will consist of patients selected by the randomization selection method who meet the inclusion criteria. The Gpower 3.1 program was used to determine the number of patients in the experimental and control groups of the study. In this context, two-way analysis of variance (TWO-WAY-ANOVA) method will be used. In conditions where the effect level was 0.40 (large effect), the error level (a) was 0.05, and the power of the test (1-B) was 0.95, the minimum sample size required for a statistically significant difference between the groups and between the measurements was obtained as 58. Each group must have at least 29 participants. In studies on the dependent variable in the literature, the drop out rate was found to be 6-12 (10-12%). Therefore, in this study, the drop out rate will be taken as 10, and the sample size will be determined as 34 for each group. The study was planned as 3 stages as randomized controlled pre-test, repeated post-test and 3rd month follow-up test. Within the scope of the study, Introductory Information Form, Visual Analogue Scale (VAS) (will be measured 3 times), Fibromyalgia Impact Questionnaire (FIQ) (will be measured 3 times), General Health Questionnaire-28 (GSA-28) (will be measured 3 times) will be applied. Within the scope of the research, it was planned to apply a PPT-based Psychoeducation Program consisting of 10 sessions, each of 120-90 minutes, to a group of participants diagnosed with FMS. The program to be implemented within the scope of the research was prepared after the literature review and together with the participant's handbook, it was sent to Positive Psychotherapy experts to get expert opinions. After the expert evaluations, necessary arrangements were made and the program was finalized. The applied Positive Psychotherapy group program was developed by the researcher by scanning the literature, the session contents, which blend three basic principles, including the real abilities of PPT, the balance model and the five-step therapy process, in order to minimize the symptoms that limit the daily life activities of FMS patients and create problems in their social lives. Information to be given, practices to be given and homework to be given for each session were determined. The purpose of the sessions was prepared by determining the targets expected to be achieved by the participants at the end of each session.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation Group | Active comparator | Behavioral: The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.The group of patients who are given psychoeducation program |
| Control Group | No intervention | –The group of patients who are not given psychoeducation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65,
- Having been diagnosed with Fibromyalgia Syndrome according to the 2016 ACR diagnostic criteria for at least 1 year,
- Agreeing to participate in the study.
Key exclusion criteria (10 listed)
- Those in acute depression
- History of a recent cardiac event such as myocardial infarction,
- History of significant head trauma,
- Peripheral neuropathy,
- Use of some centrally acting analgesic drugs such as opioids,
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 |
|---|---|---|
| The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy. | Behavioural | Psychoeducation Group |
Primary outcome
Change in Pain Perception of Fibromyalgia Syndrome Patients from Baseline
Time frame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Pain will be used to evaluate by VAS (Visual Anolog Scale) Line: A horizontal line is usually used, with the left end representing one extreme (e.g., "no pain" or "not at all") and the right end representing the other extreme (e.g., "worst pain imaginable" or "extremely intense"). Length: The line is typically 100 millimeters long Participants are provided with instructions explaining what the scale measures (e.g., pain intensity) and are asked to mark a point on the line that best represents their experience. Scoring: Measurement is done by measuring the distance in millimeters from the left end of the line to the point marked by the participant. This provides a numerical score that quantifies the individual's perception. Interpretation: A higher score on the VAS generally indicates a more intense or severe experience of the measured phenomenon.
Change in daily living activities of fibromyalgia patients from baseline
Time frame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Fibromyalgia Impact Questionnaire The Fibromyalgia Impact Questionnaire (FIQ) is a self-administered questionnaire designed to assess the health status and impact of fibromyalgia on individuals. It was developed to provide a comprehensive overview of the various aspects of fibromyalgia, including physical functioning, symptoms, and overall well-being. Physical Functioning: Work Status: Questions address how fibromyalgia affects an individual's ability to work. Depression and Anxiety: The FIQ includes questions about emotional well-being, assessing symptoms of depression and anxiety. Morning Tiredness: Measures the level of fatigue and tiredness experienced in the morning, providing insights into the impact of fibromyalgia on sleep and morning functioning. Pain Levels: Questions related to the intensity of pain experienced by individuals with fibromyalgia. Stiffness: Assesses the extent of stiffness experienced by individuals, which is a common symptom of fibromyalgia.
1 secondary outcome
Change in the mental health of fibromyalgia patients from the beginning
Time frame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
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 Aug 2024.
- Derived from this study: PubMed 40912975Erol H, Karaca A. The Effect of Positive Psychotherapy on Pain Perception, Daily Functioning, and Mental Health in Patients With Fibromyalgia. Pain Manag Nurs. 2025 Dec;26(6):e550-e560. doi: 10.1016/j.pmn.2025.07.007. Epub 2025 Sep 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy. in people with Fibromyalgia Syndrome, run by Duzce University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 Aug 2024. 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 Turkey (Türkiye). 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?
Change in Pain Perception of Fibromyalgia Syndrome Patients from Baseline (time frame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)). The study lists 2 primary outcomes in all. 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 NCT06147882, 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 Aug 2024.