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临床试验/CTRI/2024/05/067417
CTRI/2024/05/067417已完成1 期

EFFECT OF COOLING PRANAYAMA ON SALIVARY pH AND SALIVARY FLOWRATE IN YOUNG ADULTS WITH PERCEIVED STRESS: A RANDOMIZED CONTROL TRIAL

Dr Vinaya Kumar T1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Salivary pH and Salivary flowrate in ml

研究概览

简要总结

The term "stress" refers to the physical, emotional, cognitive, and behavioral reactions to situations that are perceived as challenging or threatening. Recently statistical data show the incidence of stress is high among the young adults. Yoga is an age-old practice that is considered an integral part of one’s daily life in this modern world and many practice it regularly across the globe. There are Eight Limbs in Ashtanga Yoga systematized by Maharshi Patanjali. One among them is Pranayama. Maharshi Patanjali States Pranayama as तस्मि न्सतिश्वासप्रश्वासयोर्गतिविच्छेदःप्राणायामः – regulating or transcending the movement of inhalation and exhalation is known as pranayama. Thus, yoga and pranayama help individuals cope with the stress they face in their daily life situations. Earlier studies using cooling pranayama were done on stress, autonomic variables, pulmonary function, etc… but not on salivary flowrate and salivary ph or on oral health. Therefore, the present study aims to measure the effect of cooling pranayamas on salivary pH and salivary flow rate in individuals with perceived stress.

This study aims to assess the effect of cooling pranayama on salivary pH and salivary flow rate among young adults of both genders of age group 18 -25 years with perceived stress. A total sample of 90 subjects will be included after screening and randomly divided into 2 groups where the study group (n=45) will be given cooling pranayama and the control group (n=45) will be asked to follow their routine for a period of 21 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 21).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Young Adults both males and females of age group between 18-25 years old.
  • With moderate to severe perceived stress scores.
  • Subjects who are willing and given the consent for receiving the intervention.

排除标准

  • Habit of alcohol consumption, smoking and areca chewing.
  • History of trauma to the head and neck.
  • Denture wearers.
  • History of radiotherapy.
  • Individuals with systemic or salivary gland diseases or under any drug therapy.
  • Individuals with any lesions in the oral cavity.
  • Disease of oesophagus, stomach, and intestine.
  • Those who had past exposure to pranayama or yoga therapy from last 6 months.

结局指标

主要结局

Salivary pH and Salivary flowrate in ml

时间窗: Assessments done at two time points: | 1. Pre-assessment - Day 0- Before giving the intervention. | 2. Post-assessment - Day 21 - After 3 weeks of Intervention.

次要结局

  • Perceived Stress(1st day of intervention and)

研究者

发起方
Dr Vinaya Kumar T
申办方类型
Other [Self Sponser]
责任方
Principal Investigator
主要研究者

Dr Vinaya Kumar T

Alvas College of Naturopathy and Yogic Sciences

研究点 (1)

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