The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome

NCT06147882 | Completed

• 1 other identifier: duzceuniversityhamide001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Pre-test (Before positive psychotherapy group intervention), Post- test (10 weeks after therapy) and Follow up (12 weeks after therapy)

Study Arms (2)

Psychoeducation Group

ACTIVE COMPARATOR

The group of patients who are given psychoeducation program

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

Interventions

The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy. BEHAVIORAL

The group will include patients with fibromyalgia syndrome who will receive positive psychotherapy.

Psychoeducation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Düzce Üniversitesi

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40912975 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: November 28, 2023
• Study Start: July 1, 2023
• Primary Completion: January 12, 2024
• Study Completion: May 21, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)