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临床试验/CTRI/2024/08/072153
CTRI/2024/08/072153尚未招募不适用

EFFECT OF BLUE LIGHT THERAPY AND AROMATHERAPY ON SLEEP QUALITY AND ALERTNESS AMONG INDIVIDUAL WITH SHIFT WORK SLEEP DISORDER-A RANDOMIZED CONTROL TRAIL.

Dr Shalini P Y1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
sleep quality and alertness

研究概览

简要总结

Approximately a fourth of the global workforce now engages in work outside the typical daytime and nighttime rotational hours of employment. Working during nonstandard sleep and waketimes can disrupt sleep, reduce its duration, and induce drowsiness due to the conflict between the enforced sleep-wake cycle and an individual’s circadian rhythm. For most shift workers, this misalignment of the circadian rhythm is temporary, dependent on the

extent of the phase shift experienced, and recovery occurs within a few days after returning to a regular sleep-wake schedule. There are multiple pharmacological interventions for the management of sleep disorders. The majority of these interventions have accompanying side effects and difficult to administer. Consequently, the objective of the current investigation is to comprehend the effectiveness of Blue light therapy and aromatherapy [lavender essential oil] in alleviating the symptoms that as quality of sleep and alertness associated with sleep disorder, with measurement of vital signs CBT/HR/R/BP and PSQI, THAT, MEQ, which is essential to assess physiological function of the subject and changes corresponding with the circadian rhythm misalignment.

It is crucial to comprehend the underlying mechanisms before implementing them as therapeutic agents. In the management of circadian sleep disorder particularly shift work sleep disorder, Naturopathy employs color therapy and aromatherapy as the primary treatments which is cost effective and easy to administer by them self. Therefore, this study aimed to assess the effectiveness and implementation of both interventions on circadian sleep disorders specifically shift work sleep disorder.

This study aims to assess the effect of Blue light therapy and aromatherapy on sleep quality and alertness among adults of both genders of age group 18 -50 years with shift work sleep disorder. A total sample of 70 subjects will be included after screening and randomly divided into 2 groups where the study group (n=35) will be given cooling pranayama, and the control group (n=35) will be asked to follow their routine for a period of 14 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 14).

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 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult with age group 18 to 50 years.
  • 2.Both male and female.
  • 3.Those who are working in night shifts on rotational basis.
  • 4.Having sound smelling sensation .
  • 5.Willingness to participate in the study .

排除标准

  • Light sensitivity , recent eye surgery eye infection .
  • Subjects who had participated in another clinical trail in previous 6 months.
  • 3.Pregnancy 4.With other severe Primary diseases and other co-morbid diseases.
  • 5.Taking alcohol , smoker .
  • 6.Having allergic rhinitis , asthma and other respiratory disease.

结局指标

主要结局

sleep quality and alertness

时间窗: Assessment done at two time points: | 1. Pre-Assessment -Day 0- Before giving the intervention. | 2.Post -Assessment -Day 14 -After 2 weeks of intervention.

次要结局

  • NILL(NILL)

研究者

发起方
Dr Shalini P Y
申办方类型
Other [[Self Sponser]]
责任方
Principal Investigator
主要研究者

Dr Shalini P Y

Alvas College of Naturopathy and Yogic Sciences

研究点 (1)

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