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临床试验/NCT07030374
NCT07030374已完成不适用

Effects of Conscious Connected Breathing Exercises on Sexual Function, Sleep and Mood in Women With Fibromyalgia

Adana City Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Fibromyalgia Impact Questionnaire (FIQ)

研究概览

简要总结

Our aim in this study is to investigate the effects of conscious connected breathing exercises on sexual function, sleep, and mood in fibromyalgia patients. The investigators want to clearly show how breathing exercises affect sexual function, sleep, and mood in fibromyalgia patients by comparing the results from the control and study groups before and immediately after the sessions. By experiencing and learning breathing sessions, participants can do it on their own, wherever they want, without the need for a specific tool or examination, and change their lifestyle.

详细描述

Natural CCB sessions were conducted 3 times monthly (every Monday) for approximately 1.5 hours from 16:30 to 18:00 pm by qualified breathing coach (GU). Volunteer participants were recruited randomly. Initially, they were apprised of the study's objectives and methodologies. Secondly, a researcher (GYO) gathered sociodemographic data to ascertain admission criteria. Demographic information, including the duration of follow-up since the diagnosis of FMS, chronic disease history, medications utilized, age, body mass index, and marital status, will be solicited and documented. Participants completed the Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), and Jenkins Sleep Rating Scale (JSS) and Female Sexual Function Index (FSFI). The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female fibromyalgia patients who applied to the Adana City Training and Research Hospital for physical therapy and rehabilitation outpatient clinic
  • Patients with stable period of the disease (fibromyalgia)

排除标准

  • Individuals diagnosed with schizoaffective illness,
  • Individuals utilizing antipsychotic medications,
  • Pregnant participants,
  • Participants who did not finish three sessions

结局指标

主要结局

Fibromyalgia Impact Questionnaire (FIQ)

时间窗: comparision of scales before and immediately breathing exercises among groups

The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions.FIQ is to assess the effects of fibromyalgia. The questionnaire comprises ten principal inquiries. The maximum attainable score is 100, signifying a more severe clinical condition as value rise.

Hospital Anxiety and Depression Scale (HADS)

时间窗: comparision of scales before and immediately breathing exercises among groups

The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. The HADS consists of two subscales that evaluate both anxiety and depression. The scale typically consists of 14 items, divided equally into seven questions for the anxiety subscale and seven for the depression subscale. Each question pertains to a distinct emotional condition and allows patients to assess the emotional states they have encountered during a specified timeframe (usually within the last week).

Jenkins Sleep Rating Scale (JSS)

时间窗: comparision of scales before and immediately breathing exercises among groups

The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. The Jenkins Sleep Rating Scale (JSS), a measurement instrument for evaluating sleep disturbances. The questionnaire assessed issues such as "difficulty falling asleep, waking up several times during the night, not being able to sleep without waking up during the night, feeling tired and exhausted after waking up during a normal sleep period."

Female Sexual Function Index (FSFI)

时间窗: comparision of scales before and immediately breathing exercises among groups

The assessments will be administered again to the same participants following three sessions. The results of the pre- and post-surveys will be compared. Statistical analyses were conducted to compare the scores before and immediately after the breathing exercises and evaluate the differences between the groups (study and controls). The control group consists of women diagnosed with fibromyalgia who did not participate in breathing sessions. FSFI higher score means better sexual function (maximum score 36).

次要结局

未报告次要终点

研究者

发起方
Adana City Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsum Uysal

Ass. Professor Gulsum Uysal

Adana City Training and Research Hospital

研究点 (1)

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