Depression Clinical Trial
Official title:
Effect of Hypnosis on Pain, Anxiety, and Quality of Life in Female Patients With Fibromyalgia: A Randomized Study
Verified date | May 2023 |
Source | Bursa Yüksek Ihtisas Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread pain of unknown origin, fatigue, sleep disturbances, and cognitive problems. In the treatment of FMS, it is known that pharmacological therapy reduces fatigue as well as pain, increases functionality, and has positive effects on general well-being. In functional magnetic resonance imaging (fMRI) studies, suggestion following hypnotic induction has been reported to be better at pain control in patients with FMS. Self-hypnosis is a technique performed by the patient himself. The patients were randomly divided into two groups using the closed envelope technique as Group 1: Hypnosis and Group 2: Control. Patients who had communication problems, had other rheumatological diseases, had major medical disease and received treatment, had neurological and/or central nervous system disease, had been using antipsychotic medication, had been treated with psychotherapy for the last three months, and did not want to participate in the study were excluded from the study. Demographic characteristics of the participants and fibromyalgia effect beck depression and anxiety scale, Nottingham health profile and Visual Analogue Scale (VAS) were applied and the results were recorded. At the end of the 6th month, all scales and patient controls were made and re-evaluated. In this study, we aimed to evaluate the effects of controlled, standardized adjuvant hypnosis on pain, depression, anxiety, aerobic exercise practices, quality of life, and disease impact score in patients with FMS who had been under treatment for at least six months.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: - Female - FMS patients - 35 to 65 years - receiving treatment for FMS for at least six months Exclusion Criteria: - Patients with communication problems - other rheumatological diseases - major another medical diseases - neurological and/or central nervous system diseases - severe mental illnesses - antipsychotic medication use |
Country | Name | City | State |
---|---|---|---|
Turkey | Bursa yüksek ihtisas EAH | Bursa |
Lead Sponsor | Collaborator |
---|---|
Bursa Yüksek Ihtisas Education and Research Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS | Visual Analogue Scale (VAS) was used to determine the severity of pain and fatigue of the patients.(from 0 better, 10 the worse) on a 10 cm line in VAS | the changes in scale scores from baseline to sixth month | |
Primary | depression scale | Beck depresion scale (BDI): BDI measures physical, emotional, cognitive, and motivational symptoms seen in depression. It is a self-assessment scale that includes 21 symptom categories. The highest score that can be obtained is 63, with a higher total score indicating a greater severity of depression. | the changes in scale scores from baseline to sixth month | |
Primary | anxiety | Beck anxiety scale (BAI): BAI measures the frequency of anxiety symptoms experienced by an individual. It is a Likert-type self-assessment scale consisting of 21 items, each scored between 0 and 3. A high total score indicates a high level of anxiety experienced by the person. | the changes in scale scores from baseline to sixth month | |
Primary | Fibromyalgia | Fibromyalgia Impact Questionnaire (FIQ): Except for the well-being property, low scores indicate recovery or less affliction. The maximum possible score on each subscale is 10, and the maximum total score that can be obtained is 100. | the changes in scale scores from baseline to sixth month | |
Primary | Health Profile | Nottingham Health Profile (NHP): It contains a total of 38 questions in six areas: pain, physical abilities, energy level, sleep, social isolation, and emotional reaction. The response options for each item are "yes" and "no". Each subarea is scored between 0 and 100, with 0 indicating good health and 100 representing poor health | the changes in scale scores from baseline to sixth month | |
Secondary | exercise | the patient continues to exercise at the recommended frequency (3 times a week) | at six month later |
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