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临床试验/NCT06781866
NCT06781866已完成不适用

The Impact of Relaxation Massage Prior to Bed-time on Sleep Quality and Quantity in People with Symptoms of Chronic In-somnia: a Home-Based Sleep Study.

University of Thessaly1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月9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
入组人数
20
试验地点
1
主要终点
Sleep Efficiency

研究概览

简要总结

Manual massage is an effective treatment approach for reducing general stress and promoting an overall sense of wellbeing. Relaxation massage aims to alleviate psychophysiological tension, enhance both blood and lymphatic circulation, and promote mental and physical relaxation. It is particularly beneficial for those with anxiety-related symptoms (such as generalized anxiety dis-order, social anxiety) and sleep disorders, aiming to improve calmness and promote sleepiness. The purpose of the present study is to assess the effectiveness of a single session of relaxation massage prior to bed-time on sleep quality and quantity indices, in individuals with symptoms of chronic insomnia.

详细描述

Study Design:

The current study will assess the impact of an in-house full-body deep relaxation massage session performed by a professional masseur in objective measurements of sleep quality and quantity in participants suffering from chronic insomnia just before they go to bed.

The volunteers of the current study will participate in 3 different scenarios, each 5 days apart: Scenario 1 is the control session when participants' sleep will be recorded without any massage intervention. Participants will follow their usual bed-time routine.

Scenario 2, participants will receive a deep relaxation massage session lasting 40 min and follow the sleep recording set up before they follow their usual bedtime routine.

Scenario 3, participants will receive a placebo massage session lasting 40 min (oil rubbing application in participants' body places similar to the massage session) and followed by the sleep recording set up before they follow their usual bedtime routine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •score of ≥16 on the Athens Insomnia Scale (AIS-8)

排除标准

  • •history of mental illness, dermatological diseases, allergies to massage oil and any acute or chronic condition that would limit the ability of the patient to participate or consent in the study

研究组 & 干预措施

Control

No Intervention

For the control (CON) session participants will not receive any massage session and they will follow their usual bedtime routine.

Relaxation Massage

Experimental

For the relaxation massage (REL) session, participants will receive a massage session lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine

干预措施: Massage (Other)

Sham Massage

Sham Comparator

For the sham" massage (PLA) session, participants will receive a sham-massage session (full body oil rubbing) lasting for 45 minutes before bedtime and they will instructed to follow their usual bedtime routine

干预措施: Sham (No Treatment) (Other)

结局指标

主要结局

Sleep Efficiency

时间窗: 9 hours

Total sleep time over Time spend in bed

次要结局

  • Sustained Sleep Efficiency(9 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgos K. Sakkas

Associate Professor

University of Thessaly

研究点 (1)

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