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临床试验/CTRI/2024/09/074411
CTRI/2024/09/074411尚未招募不适用

Effect of Heart Rate Variability Biofeedback on Somatic Symptom Disorder

AIIMS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
40
试验地点
1
主要终点
To study the effect of 4 weeks of Heart Rate Variability biofeedback training in patients with Somatic Symptom Disorder on:

研究概览

简要总结

Somatic symptom disorder presents a problem for both the physician and patient because it puts patients at risk of unnecessary testing and treatment. The main feature of these disorders is a concern with physical symptoms that are attributed to a nonpsychiatric disease. This concern can manifest as one or more somatic symptoms that result in excessive thoughts, feelings, or behaviors related to those symptoms and that are distressing or result in significant disruption of daily life. HRV biofeedback (HRVB) is a non-invasive therapeutic modality that has been shown to be effective as an adjunct therapy in various chronic pain disorders with stress as a pathophysiological feature.

Very few studies have investigated the effect of heart rate variability HRV biofeedback (HRVB) training as an adjunct therapy in Somatic Symptom Disorder. Very little information is available on the effect of HRVB on the pain and functional status in Somatic Symptom Disorder. On the other hand, there is a lack of information regarding the objective evaluation of HRVB on the pain status in Somatic Symptom Disorder.

Therefore, the present study is planned to investigate the effect of heart rate variability biofeedback (HRVB) on pain status,functional status and baroreceptor sensitivity in Somatic Symptom Disorder patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.A minimum score of 5 in the Patient Health Questionnaire 15 (PHQ-15) 2.Presence of at least two somatic complaints with predominant pain.

排除标准

  • 未提供

结局指标

主要结局

To study the effect of 4 weeks of Heart Rate Variability biofeedback training in patients with Somatic Symptom Disorder on:

时间窗: Baseline and at 4 weeks

a. Somatic symptom disorder severity (Patient Health Questionnaire-15,Somatic Symptom Disorder-8)

时间窗: Baseline and at 4 weeks

b. Pain status (Visual Analog Scale, Quantitative Sensory Testing)

时间窗: Baseline and at 4 weeks

c. Heart Rate Variability

时间窗: Baseline and at 4 weeks

次要结局

  • NA(NA)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Renu Bhatia

AIIMS New Delhi

研究点 (1)

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