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临床试验/NCT07141940
NCT07141940已完成不适用

The Role of Indonesian-Language Application-Based Auditory Guided Imagery Therapy on The Reduction of Insomnia Severity Index and Fasting Blood Glucose Levels in Diabetic Patients With Insomnia

Dr Cipto Mangunkusumo General Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年5月6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
66
试验地点
1
主要终点
Fasting Plasma Glucose

研究概览

简要总结

The goal of this clinical trial is to learn if guided imagery therapy using mobile application in Indonesian language can improve sleep quality and lower fasting blood glucose levels in diabetics patients who have problems with their sleep.

The main questions it aims to answer are:

  • Can the app-based guided imagery therapy help improve sleep quality in diabetic patients who have trouble sleeping?
  • Can the app-based guided imagery therapy help lowering fasting blood glucose in diabetic patients who have trouble sleeping? Researchers will compare app-based guided imagery therapy to education about how to sleep well, to see if the app works to improve sleep quality and lower blood glucose.

Participants will:

  • Receive education about how to sleep well
  • Use the app 3 times a week for 4 weeks (only for group who receive the app)
  • Visit the clinic after 4 weeks for tests

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients at Endocrinology or Psychosomatic Clinic, Cipto Mangunkusumo Hospital
  • •Already diagnosed with Diabetes Mellitus
  • •HbA1c less than 12%
  • •Insomnia Severity Index more than 8
  • •Lives in Jakarta, Bogor, Depok, Tangerang, or Bekasi
  • •Able to understand the Indonesian language well

排除标准

  • •History of amputation or routine hemodialysis
  • •No device available to connect with the application
  • •Inability to independently access or use the application
  • •Inability to perform self-monitoring of blood glucose at home
  • •Hearing impairment
  • •Cognitive impairment or intellectual limitations

研究组 & 干预措施

Intervention Group

Experimental

The participants receive psychoeducation at the enrollment. Then, they were asked to use the Indonesian-language application-based auditory guided imagery therapy 3 times a week for 4 weeks.

干预措施: Indonesian-language application-based auditory guided imagery therapy (Other)

Control Group

Active Comparator

The participants receive only psychoeducation at the enrollment.

干预措施: Psychoeducation (Other)

结局指标

主要结局

Fasting Plasma Glucose

时间窗: 4 weeks

Insomnia Severity Index

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
Dr Cipto Mangunkusumo General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rudi Putranto

Dr. dr. Rudi Putranto, Sp.PD, K-P.P.M, MPH

Dr Cipto Mangunkusumo General Hospital

研究点 (1)

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