Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147882
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-10-06
Brief Title:
The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome
Sponsor:
Duzce University
Organization:
Duzce University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 123 Positive Psychotherapy supports individuals in symptom management to use their resources to overcome difficulties understand and recognize growth areas with a therapeutic approach4 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 31 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 040 large effect the error level a was 005 and the power of the test 1-B was 095 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None