Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, Fatigue, and Heart Rate V… (NCT07402460) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, Fatigue, and Heart Rate Variability Among Individuals With Poor Sleep Quality
Taiwan32 participantsStarted 2025-08-01
Plain-language summary
The goal of this clinical trial is to evaluate whether a structured reflexology therapy can improve sleep, reduce insomnia severity, and alleviate fatigue in adults with poor sleep quality, and to understand how it affects autonomic nervous system function. The main questions it aims to answer are:
* Can manual reflexology treatment improve sleep quality as measured by standardized sleep assessments?
* Can manual reflexology influence physiological measures of autonomic function (such as heart rate and heart rate variability)?
Researchers will compare the effects of a manual reflexology intervention to those of a mechanical foot massage to determine which approach is more effective in improving sleep, reducing insomnia severity, and enhancing fatigue and autonomic balance.
Participants will be asked to:
* Undergo weekly sessions of manual reflexology therapy for six weeks, and
* Undergo weekly sessions using mechanical foot massage equipment for six weeks, with heart rate, heart rate variability, and sleep and fatigue questionnaires measured before and after each intervention period.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. . Aged between 40 and 80 years.
. . Had no prior experience with, or had not regularly received, feet massage treatments.
. . Had a global score greater than 10 on the PSQI, indicating poor sleep quality.
Exclusion criteria
. . Presence of bacterial or viral infections on the feet.
. . Acute infectious diseases, bleeding or coagulation disorders, psychiatric conditions, open wounds, or bone fractures.
. . Conditions such as extreme fatigue, physical weakness, alcohol intoxication, or long-term bedridden status that prevented attendance at the study site.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep Quality
Timeframe: Baseline and after 6 weeks of each intervention period
Trial details
NCT IDNCT07402460
SponsorNational Taipei University of Nursing and Health Sciences