跳至主要内容
临床试验/NCT04915742
NCT04915742已完成不适用

Master Physiotherapist

Inonu University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Short Form-36

研究概览

简要总结

Summary

Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study started with 58 people who wanted to participate in the study from online platforms and the study was completed with 34 people.

Findings: According to the power analysis, at least 34 people will participate in the study. Participants will be divided into 2 groups as experimental and control, thetahealing and exercise will be applied to the experimental group and only exercise sessions will be applied to the control group. The study will be 2 sessions of online group exercises per week for 6 weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks. The evaluation will be carried out in the first week before the sessions start and in the last week after the sessions are completed in the form of an online survey.Summary

Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study started with 58 people who wanted to participate in the study from online platforms and the study was completed with 34 people.

Findings: According to the power analysis, at least 34 people will participate in the study. Participants will be divided into 2 groups as experimental and control, thetahealing and exercise will be applied to the experimental group and only exercise sessions will be applied to the control group. The study will be 2 sessions of online group exercises per week for 6 weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks. The evaluation will be carried out in the first week before the sessions start and in the last week after the sessions are completed in the form of an online survey.

详细描述

Login Fibromyalgia (FM) is a non-articular, chronic rheumatic disease of unknown etiology, characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points (1). Diagnostic criteria were defined by the American Rheumatism Association (ARA) in 1990 (2). In order to diagnose FM, there should be widespread pain and sensitivity in 11 or more of 18 specific points (3). The etiopathogenesis of FM is still unknown, but factors such as physical trauma, surgical intervention, infections, acute or chronic emotional stress may play a triggering role (4). Various findings such as muscular symptoms, cognitive complaints, depression, insomnia and fatigue accompanying chronic pain have been described in patients with FM (5). Various psychopathological disorders have been reported in FM. It is estimated that 1/3 of his patients have minor depression or anxiety. However, it is not known whether anxiety and depression in FM cause chronic pain or contribute to the severity of symptoms (3). Despite the various complaints of patients with fibromyalgia, the fact that no significant impairment was found in physical examination and laboratory tests suggests that the symptoms may be psychologically induced (6). Since the etiology of fibromyalgia syndrome is unknown, pharmacological and non-pharmacological treatment methods should be used in patient-specific combinations according to the prominent symptoms and their severity (6).

Mental health as well as the physical health of FMS patients is frequently investigated. It has been observed that depressions accompany FMS in the majority of patients (7 -11). Likewise, FMS patients frequently get various psychiatric comorbidities such as panic disorder and anxiety (12,13). In addition, studies consistently point to an increased rate of designed suicide after the development of fibromyalgia in this patient group due to the burden of the disease and the high prevalence of depression (14-16).

The role of psychological factors in fibromyalgia is a controversial issue. However, many studies have shown that these patients experience deterioration in personality patterns, increased stress levels, anxiety, depression, or other psychological symptoms (17,18). Although psychological factors are not considered to be the primary cause of fibromyalgia, there are findings that depression is a very important predictor of the development of FMS (12,19). On the other hand, researchers have pointed out that fibromyalgia and depression generally have two-way relationships by overlapping (18,20).

Theta gets its name from Teta brain waves. Generally, at night, while sleeping, during deep meditation , and experiencing oneness in the universe, situations occur at the theta wavelength. So the Theta state is a very deep state of relaxation . While in this wavelength , we can easily connect with the brain so that our haunted beliefs here can be controlled. This condition is associated with strong theta rhythmic activity patterns. Theta activities occur in the electroencephalogram (EEG) between the client and the practitioner at a wavelength of 4-7 Hz (21). ThetaHealing® (Vianna Stibal, Kalispell, MT) is a spiritual healing method in which practitioner and client participate in joint meditations during several subliminal sessions. Thetahealing is practiced by people who are internationally trained in this field. It is claimed that these meditation periods are characterized by a "theta state" in which the presence of theta waves in the electroencephalograph (EEG) frequency spectrum of both the practitioner and the client is assumed (21) .

Located above the psychological and physiological bases for fibromyalgia origin information in light of the Fibromyalgia Patients Group Exercise ii and Thetahealing Pain and e on quality of life TKİ designed this study to determine n.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Short Form-36

时间窗: 6 weeks

The Short Form-36 is a 36-item short-form questionnaire measuring eight health-related quality-of-life domains: physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP), and general health perception (GH). The SF-36 also includes an item for assessing changes in participant's health status over the past year. It is a scale between 0 (worst) and 100 (best) using the standard SF-36 scoring algorithms, with item scores coded, aggregated for each quality of life domain tested.

Numerical Pain Scale

时间窗: 6 weeks

Numerical Analog Scale (NAS) A scale with values from 0 to 10. Pain in the last 24 hours is evaluated with NAS. If 0 on the scale, I have no pain and 10 means unbearable pain and it is reported that the severity of the pain increases from 0 to 10.

Fibromyalgia Impact Questionnaire

时间窗: 6 weeks

The Fibromyalgia Impact Questionnaire (FEA) measures 10 different characteristics: physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. FEA is filled by the patient. The maximum possible score of each sub-title is 10. Thus, the total maximum score is 100. The average FM patient scores 50, while more severely affected FM patients usually score above 70.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naciye Dilruba Tektas Gulbil

physioterapist

Inonu University

研究点 (2)

Loading locations...

相似试验