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临床试验/NCT06778876
NCT06778876已完成不适用

Effect of Lavender on Sleep Quality and Insomnia Severity in Patients With Psychophysiological Insomnia

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
The Pittsburgh Sleep Quality Index

研究概览

简要总结

Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature is reviewed, no studies examining the effects of lavender oil on patients with psychophysiological insomnia were found. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.

详细描述

Today, psychophysiological insomnia is the most common persistent insomnia. The patient's inability to sleep occurs as a result of repetitive negative thoughts such as the thought that he will have difficulty sleeping before going to bed and/or past experiences involving the bedroom or the night. More effort to sleep causes more wakefulness and more difficulty falling asleep.

Numerous studies have shown that insomnia seriously affects health and quality of life and can cause various problems including memory problems, depression, irritability, cardiovascular and cerebrovascular diseases, etc. Therefore, looking for effective ways to improve sleep quality is important for individual and social health. Today, drug therapy, psychotherapy, physiotherapy and cognitive-behavioral therapy are widely used treatments for insomnia. Recently, more and more studies have found that aromatherapy is one of the non-drug treatments to improve sleep quality. Lavender essential oil appears in the literature as an aromatherapy method frequently used to improve sleep quality.

Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature was examined, no studies were found examining the effects of lavender oil on patients with psychophysiological insomnia. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.

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
Double (Participant, Outcomes Assessor)

盲法说明

participants and outcome assessors will not be informed about group assignments and will be blinded.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being 18 years of age or older,
  • •Being over 65 years old
  • •Being diagnosed with psychophysiological insomnia,
  • •Knowing Turkish at a level that will allow you to read and understand the survey questions,
  • •Accepting to participate in the study

排除标准

  • •Having a serious physical or cognitive disability that would prevent him/her from answering the survey,
  • •Being under the age of 18,
  • •Not accepting to participate in the study,
  • •Being allergic to lavender,
  • •Having a chronic additional disease related to the respiratory system,
  • •Having a psychiatric or neurological additional disease,
  • •Using medication(s) that may affect sleep,
  • •Experiencing a physical activity limitation that causes bedriddenness,
  • •Having or contracting a disease that will affect the ability to smell.

研究组 & 干预措施

lavender sachet group

Active Comparator

The normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks.

干预措施: lavender sachet group (Other)

Control group

Sham Comparator

Participants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed.

干预措施: control group (Other)

结局指标

主要结局

The Pittsburgh Sleep Quality Index

时间窗: two weeks

PSQI is a 19-item scale, assessed by self-report (19 items) and spouse/roommate responses (5 items). The scale includes components such as sleep quality, duration, and disturbance, and the total score ranges from 0 to 21; a score greater than 5 indicates poor sleep quality.

次要结局

  • The Insomnia Severity Index(two weeks)
  • The Epworth Sleepiness Scale(two weeks)

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

bülent devrim akçay

University of Health Sciences

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (1)

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