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临床试验/NCT05840939
NCT05840939已完成不适用

The Effect of Pranayama and Diaphragmatic Breathing Exercise on Sleep Quality, Pain and Fatigue Level in Female Patients With Fibromyalgia

Inonu University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月11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
100
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

Female patients diagnosed with fibromyalgia were divided into pranayama breathing exercise, diaphragm breathing exercise and control groups. The sleep quality, pain and fatigue levels of the patients in the intervention group were determined before and after the breathing exercise.

详细描述

Aim: This study was conducted to determine the effect of pranayama and diaphragm breathing exercises applied to female patients diagnosed with fibromyalgia on sleep quality, pain and fatigue levels.

Material and Method: This study, designed as a randomized controlled and experimental study, was conducted between November 2022 and June 2023. The data of the study consisted of 100 female patients diagnosed with fibromyalgia: 32 in the pranayama group, 33 in the diaphragm breathing exercise group and 35 in the control group. As data collection tools; Patient Information Form, Visual Analog Scale, Fatigue Severity Scale and Pittsburgh Sleep Quality Scale were used. During the study, the control group received routine treatment, while the two groups in the intervention group received the following training given by the researcher; They were asked to do pranayama and diaphragm breathing exercise 3 sets a day (morning-afternoon-evening), 7 days a week for 6 weeks. At the end of this process, sleep quality, pain and fatigue levels of three groups were evaluated again.

Results: It was observed that there was no statistically significant difference between the initial pain and sleep quality total scores of three groups (p>0.05), there was a significant difference between the groups in terms of pain, fatigue and sleep quality scores after the application (p<0.05).

Conclusion: As a result, it was determined that breathing exercises reduced the patients' pain and fatigue levels and improved their sleep quality.

Keywords: Pain, diaphragmatic breathing, fibromyalgia, pranayama, sleep quality, fatigue

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
Single (Participant)

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

  • ● Being 18 years or older
  • Being a female patient who has had pain for at least three months and has been diagnosed with fibromyalgia by a physician according to the ACR 2016 fibromyalgia diagnostic criteria.
  • Having a PSQI score of five and above
  • Complaint of fatigue and getting a score of 4 or above on the fatigue severity scale
  • Pain score of one or above according to VAS
  • Having no communication problems and knowing how to read, write and speak Turkish
  • Not being pregnant and not breastfeeding

排除标准

  • Having a malignancy related to the respiratory system (bronchus or lung)
  • Having tuberculosis disease
  • Having chest pain
  • Having any psychiatric diagnosis during outpatient clinic screenings
  • Having a nasal septum derivation or adenoid that will affect the ventilation process
  • Having previously practiced/trained in pranayama or diaphragmatic breathing exercises

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: [Time Frame: 6 weeks]

"0" indicates no pain and "10" indicates the most severe level of pain. On the scale, \<3 mild pain, 3-6 moderate pain, \>6 severe pain were specified.

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

Meltem Sungur

Principal Investigator

Inonu University

研究点 (1)

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