Clinical trial NCT06147882: The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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,
* 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

Primary outcomes:
measure: Change in Pain Perception of Fibromyalgia Syndrome Patients from Baseline
timeFrame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
measure: Change in daily living activities of fibromyalgia patients from baseline
timeFrame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Secondary outcomes:
measure: Change in the mental health of fibromyalgia patients from the beginning
timeFrame: Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)
Other outcomes:
Locations:
city: Düzce
country: Turkey
facility: Düzce Üniversitesi
Study officials:
References: