Self-acupressure to Improve Insomnia Among the Elderly With Hypertension: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
The goal of this study is to evaluate the feasibility and the effect of self-acupressure on improving insomnia among the elderly with hypertension who reported insomnia (using the Insomnia Severity Index questionnaire)
The main questions it aims to answer are:
- Is the proposed intervention feasible to deliver to the target population in terms of recruitment, retention, adherence, and completion of outcome assessments?
- Does self-acupressure improve insomnia among the elderly with hypertension? Researchers will compare participants in the self-acupressure group (practice acupressure at home for 28 days) and the enhanced standard care group to see the effectiveness of acupressure in improving insomnia for hypertensive elderly individuals.
Participants in the self-acupressure group will be instructed how to locate and perform acupressure, then they will be asked to practice acupressure at home for 28 days (once a day).
Participants in the enhanced standard care group will receive training on how to apply sleep hygiene rules and will be asked to follow sleep hygiene rules for 28 days.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertention patient who are ≥ 60 years old
- •Having Insomnia Severity Index score ≥ 11
- •Having Karnofsky score ≥ 80.
排除标准
- •Patients who are currently participating in clinical trials for the treatment of insomnia.
- •Patients who are currently receiving pharmacological treatment for insomnia.
- •Patients with concomitant cardiovascular conditions, such as heart failure; patients with an implanted pacemaker; patients who have an indication for catheter-based cardiovascular intervention; or patients who have an indication for cardiovascular surgery.
- •Patients with psychiatric disorders, such as depression, generalized anxiety disorder, or bipolar disorder.
研究组 & 干预措施
Acupressure group
Participants will receive a self-acupressure training section and requested to practice acupressure at home once a day at night time (before going to bed) for four weeks. During that time, participants will receive a weekly phone call follow up from researchers. By the end of week fourth, participants will be requested to complete post-intervention assessment. A short-term follow up will be then carried out in 4 weeks. By the end of follow up time, participants will be asked to complete post follow up assessement and received 200.000 vnd (12 usd) as complimentary.
The acupressure protocol of the intervention was developed and validated by 6 traditional and hypertensive experts.
干预措施: Acupressure to improve insomnia (Other)
Control group
Participants in the control group will receive a training session on sleep hygiene rules and will be ask to practice thoes rule in 28 days. Weekly telephone reminder will also be made in four week. By the end of week fourth, participants in this group will be requested to complete post-intervention assessment. A short-term follow up will be then carried out in 4 weeks. During the follow-up period, participants receive no weekly telephone reminder. By the end of follow up time, researchers will make a telephone reminder to participants and ask them to complete and send back all the follow-up assessment questionnaire. 200,000 vnd (equal to 12 usd) will be given to participants for complymentary
结局指标
主要结局
Insomnia severity
时间窗: Insomnia severity will be measured at 3 time points: Baseline, Week 4, and Week 8
The Insomnia Severity Index (ISI) is used to measure insomnia severity among participants. This instrument had been validated translated into Vietnamese previously and was being used in the cross-sectional study with high reliability (Cronbach's α = 0.92).
次要结局
- Feasibiliy outcomes(The recruitment rate will be measured at baseline)
- Feasibility outcome(The acceptability score of the intervention will be measured at week 4)
- Feasibility outcome(Through study completion, an average of 1 year)
研究者
Hoang T.X Huong
Head of Nursing and Midwifery Faculty
Phenikaa University