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临床试验/CTRI/2023/11/060336
CTRI/2023/11/060336尚未招募2/3 期

A comparative Study on effect of lavender oil and lemongrass oil on mental health and concentration in healthy individuals with academic stress

DrKSugirtha1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
DASS-21 – Depression anxiety stress scale

研究概览

简要总结

Introduction:

  • Stress is an innate response of the body that may be either physical, mental, or emotional to an unforeseen event that occurs in the life of the individual.
  • Academic life is one of the events in an individual’s life that may have different stressors.
  • Contemporary literature suggests that university life is subjected to different stressors arising from academic pressure, social problems, and personal issues.
  • It may also involve living away from the family which brings social isolation and adds to personal vulnerability.
  • Negative mental health leads to decreased energy, difficulty thinking, concentrating, and making career decisions. Students are a pillar of the future in building an educated society.

Aromatherapy:

  • Aromatherapy is the popular complementary therapy that uses essential oils (also known volatile oils) from parts of the plants for the improvement of physical, emotional and spiritual well-being.
  • Lavender and lemongrass oil as an herbal remedy has been associated with anxiolytic properties.
  • It was suggested that the anxiolytic and antidepressant effects could be associated with the suppression of the activity of the sympathetic nervous system and it is perceived as pleasant and displays a relaxing activity, it has been employed in aromatherapy in different therapeutic contexts.

Study design:

  • A Comparative Pre-Post study design will be adopted for this study. All the eligible subjects will be divided into two groups, Lavender group and Lemongrass group.
  • Group 1 will receive inhalation of Lavender oil for 10 minutes/day & Group 2 will receive inhalation of Lemongrass oil for 10 minutes/day for a period of 30 days.
  • Assessments will be done before the intervention, 15th day and after the intervention of 30 days.

Sample size : (n=100)

Randomization and Blinding:

  • Subjects will be randomly divided (1:1 ratio) into Lavender group and Lemongrass group.
  • Allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique.
  • Subjects and investigators will not be blinded in the study.

Primary Outcome:

  • DASS-21 – Depression anxiety stress scale
  • PSQI – Pittsburgh sleep quality index
  • SLCT – Six letter cancellation task
  • DLST - Digit letter substitution test

Secondary Outcome:

  • BP – Blood pressure
  • HR - Heart rate

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Subjects who are willing to participate in the study.

排除标准

  • Subjects with Generalized anxiety disorder Subjects with Major depressive disorder Women during Pregnancy & lactation Subjects with other co-morbidities Subjects with head injury & Migraine Subjects who are on Anti-Psychotic & Anti-epileptic medications Subjects with learning disability Subjects with developmental delay Subjects with ENT Disorders Subjects with claustrophobia.

结局指标

主要结局

DASS-21 – Depression anxiety stress scale

时间窗: 1st week | 3rd week | 6th week

PSQI – Pittsburgh sleep quality index

时间窗: 1st week | 3rd week | 6th week

SLCT – Six letter cancellation task

时间窗: 1st week | 3rd week | 6th week

DLST - Digit letter substitution test

时间窗: 1st week | 3rd week | 6th week

次要结局

  • BP - Blood pressure(HR - Heart rate)

研究者

发起方
DrKSugirtha
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr K Sugirtha

International Institute of Yoga and Naturopathy Medical Sciences

研究点 (1)

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