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临床试验/NCT07328763
NCT07328763进行中(未招募)不适用

The Effect of Pranayama Breathıng Exercıses on Paın, Anxıety,aAnd Sleep Qualıty in Indıvıduals wıth Fıbromyalgıa

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
54
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

Individuals diagnosed with fibromyalgia syndrome have a low quality of life due to factors such as pain, sleep problems, high anxiety, depression and low self-esteem, difficulty performing daily living activities, and inhibited socialization (García-Martínez et al., 2012; Sieczkowska et al., 2020). Nurses apply care with a holistic approach philosophy that includes supportive, preventive, therapeutic, and rehabilitative aspects to promote and maintain health. Pranayama is an effective, non-invasive, cost-effective, and easily applicable approach that can be implemented within the framework of holistic care (İlter & Ovayolu, 2021). It is the nurse's responsibility to provide care and create a comfortable environment for patients, improving their quality of life (Aktaş & İlgin, 2023). In this regard, during the application and teaching of breathing exercises, nurses should carefully assess patients' belief in these exercises. They should plan with the patient the appropriate time, duration, and environment for breathing exercises and be able to evaluate the results (ÖZ, 2020). Studies evaluating the results of applying pranayama to individuals with fibromyalgia are limited in the literature. Therefore, it is thought that pranayama could greatly facilitate and provide concrete data on improving the quality of life for individuals with fibromyalgia by reducing pain, sleep problems, anxiety, and improving functionality.

详细描述

Fibromyalgia syndrome (FMS) is a rheumatological syndrome characterized by symptoms such as increased pain sensitivity, sleep disturbances, fatigue, musculoskeletal pain, stiffness, tenderness, cognitive dysfunction, and mood disorders due to dysregulation of neurophysiological functions (Singh & Rao, 2023; Verma et al., 2020). The incidence of FMS in the general population is reported to be 2-8%, predominantly affecting women (between 61% and 90%), with a male/female ratio of 2.3 (Galvez-Sánchez et al., 2019; Jones et al., 2015; Schmidt-Wilcke & Diers, 2017). Although there are insufficient prevalence studies in Turkey, a study conducted in the Trabzon region found the prevalence of FMS to be 3.6% in women aged 20-64 and 0.9% in women aged 20-29 (Topbas et al., 2005).

The American College of Rheumatology (ACR) first defined the FM Diagnostic Criteria in 1990, and these criteria were revised in 2010, 2011, and 2016 (Plesner & Vaegter, 2018). While there is no definitive treatment method, pharmacological and non-pharmacological treatment methods are applied. Non-pharmacological treatments include acupuncture, biofeedback, capsaicin, chiropractic, cognitive behavioral therapy, exercise, hydrotherapy, spa therapy, massage, meditative movement (Qigong, yoga, and Tai Chi), mindfulness/mind-body therapy, multicomponent therapy, and S-adenyl methionine. In addition, methods such as physical therapy, stretching, strengthening, aerobic exercise, and endurance training are also used (Chitra et al., 2017; Prabhakar et al., 2019).

Fibromyalgia is a common disease associated with numerous comorbidities and is often difficult to diagnose, which can have a devastating impact on quality of life, impair patients' abilities, lead to social and psychological problems for patients, and create a significant socioeconomic burden on healthcare systems (Atahan et al., 2023; Kang et al., 2022).

Fibromyalgia presents with chronic pain without any apparent peripheral tissue damage. This pain results from threatening tissue damage that activates peripheral nociceptors without real or definitive evidence (Ruschak et al., 2023). The pain is characterized by morning stiffness and increasing intensity throughout the day, is anatomically widespread, and is accompanied by hyperexcitability with increased response of the central nervous system to various stimuli (pressure, temperature, light, and medication, etc.). It is characterized by hyperalgesia, allodynia, and features reflected in multiple spinal segments (Araya-Quintanilla et al., 2020).

Patients with FM syndrome may experience emotionally impactful situations in the form of high levels of stress, anger, and catastrophic scenario-based pain, and these situations can worsen existing symptoms (Galvez-Sánchez et al., 2019). Studies have reported that a significant proportion of FM patients experience depression, panic disorder, and anxiety disorder (Basar et al., 2023; Siracusa et al., 2021). It is thought that the cognitive and psychological processes experienced by patients are related to pain (Cetingok et al., 2022). One study reported that FS patients were more likely to experience depression (20%-80%) and anxiety (13%-63.8%) (Henao-Pérez et al., 2022). A meta-analysis study suggested that the lifetime prevalence of depression in fibromyalgia is approximately 65% (Galvez-Sánchez et al., 2020).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Individuals aged 18 and over,
  • having experienced pain for at least three months,
  • diagnosed with fibromyalgia by a physician according to the ACR 2016
  • romyalgia diagnostic criteria,
  • having a PUKI score of five or higher,
  • having a VAS pain score of one or higher,
  • having no communication problems,
  • and not being pregnant.

排除标准

  • Individuals with a history of respiratory diseases such as malignancy or tuberculosis,
  • those with a psychiatric diagnosis,
  • those with nasal obstruction due to septal deviation,
  • and those who have previously participated in a similar breathing exercise program will be excluded from the study.

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 6 Weeks

To indicate the severity of your pain, place an (I) mark on one of the lines below. 0 points: no pain, 1-2 points: very mild pain, 3-4 points: mild pain, 5-6 points: moderate pain, 7-8 points: severe pain, 9-10 points: very severe pain.

Beck Anxiety Scale (BAS)

时间窗: 6 Weeks

Some symptoms that people experience when they are anxious or worried.

Pittsburgh Sleep Quality Index (PSQI)

时间窗: 6 Weeks

questions only relate to habits from the past month.

Fibromyalgia Impact Questionnaire (FIQ)

时间窗: 6 Weeks

Severity of fibromyalgia symptoms

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aybike Kose

Registered Nurse (RN)

Ondokuz Mayıs University

研究点 (1)

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