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NCT Number: NCT07402460

Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, Fatigue, and Heart Rate Variability Among Individuals With Poor Sleep Quality

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Poor Sleep Quality

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, 112303, Taiwan

About this study

Poor sleep quality is a common health concern associated with impaired autonomic nervous system regulation and increased risk of physical and psychological disorders. Complementary therapies, such as foot reflexology, are widely used to promote relaxation and improve sleep; however, evidence regarding their physiological effects and comparative effectiveness remains limited. This study was designed to examine whether a structured manual reflexology treatment can improve sleep-related outcomes and autonomic nervous system function in adults with poor sleep quality, compared with mechanical foot massage.

Participants enrolled in this study undergo two different foot-based interventions-manual reflexology treatment and mechanical foot massage-delivered in separate intervention periods. Each intervention period lasts six weeks, with one session per week. The order of interventions is assigned using a randomized crossover design, allowing each participant to receive both treatments while minimizing individual differences.

Manual reflexology sessions are delivered by a trained practitioner following a standardized and reproducible protocol, which targets specific foot reflex zones associated with relaxation and autonomic regulation. Mechanical foot massage sessions are conducted using commercially available foot massage equipment under standardized conditions. Both interventions are designed to be non-invasive and well tolerated.

Throughout the study, participants' physiological responses are monitored using non-invasive measures of heart rate and heart rate variability, which provide insight into autonomic nervous system activity. In addition, participants complete validated questionnaires assessing sleep quality, insomnia severity, and fatigue. By comparing changes observed after each intervention, this study aims to clarify whether manual reflexology offers added benefits over mechanical massage and to explore the potential role of autonomic modulation in improving sleep-related outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • . Lower limb amputation or significant limb deficiency.
  • . Employment involving rotating or shift work.

Treatment and study plan

manual reflexology treatment

Behavioral

The manual reflexology procedure was carried out following a standardized sequence, targeting specific foot reflex zones. The detailed steps were as follows:

  • Preparation: All participants were positioned in a semi-recumbent supine posture on a treatment bed, with appropriate towel draping to ensure comfort and privacy. The massage bed and chair were disinfected with 75% alcohol and covered with a clean foot towel.
  • Foot Relaxation Techniques: The treatment began with relaxation techniques (e.g., friction and oscillation) applied first to the left foot, followed by the right.
  • Reflex Zone Stimulation Techniques: Five core massage techniques-pressing, kneading, pushing, scraping, and acupressure-were applied systematically across different reflex zones, as described below:

I. Toe Region (2 min/foot): Brain, frontal lobe, pituitary gland, temples, cerebellum, nose, cervical area, eyes, ears, upper/lower jaw, tonsils, vocal cords, esophagus, and trachea.

II. Medial Foot (2 min/

Feet massage using an electric massager (FEM)

Behavioral

Each session lasted 30 minutes and was conducted using the device's pre-set "fatigue relief" mode, which applied medium-intensity pressure combined with a mild heating function. The massage covered the following regions with different mechanical actions. (1) Plantar region (sole of the foot): Targeted zones included the thoracic, abdominal, and pelvic areas. The massage's methods were delivered using rolling, pressing, squeezing, and vibration techniques. (2) Medial and lateral sides of the foot: These areas were stimulated through squeezing, pressing, and vibration. (3) Dorsal foot region (top of the foot): This region was massaged using squeezing, pressing, and vibration. (4) Calf region: The device provided massage through squeezing, pressing, and vibration to promote circulation and muscle relaxation. All participants received the same standardized massage setting to ensure consistency throughout the intervention period.

Primary outcomes

  1. Sleep Quality

    Time frame: Baseline and after 6 weeks of each intervention period

    Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire that evaluates overall sleep quality and seven component domains, including sleep latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. Higher scores indicate poorer sleep quality.

Secondary outcomes

  1. Insomnia Severity

    Time frame: Baseline and after 6 weeks of each intervention period

    Insomnia severity is measured using the Insomnia Severity Index (ISI), a validated 7-item self-report questionnaire assessing perceived severity of insomnia symptoms, sleep satisfaction, daytime impairment, and distress related to sleep difficulties. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.

  2. Fatigue Severity

    Time frame: Baseline and after 6 weeks of each intervention period

    Fatigue is assessed using the Fatigue Assessment Scale (FAS), a validated self-reported questionnaire evaluating both physical and mental fatigue. Higher total scores indicate greater perceived fatigue.

  3. Autonomic Nervous System Function (Heart Rate Variability)

    Time frame: Baseline and immediately after intervention at week 1 and week 6 of each intervention period

    Autonomic nervous system function is evaluated using heart rate variability (HRV) derived from electrocardiogram recordings. Time-domain indices (SDNN, RMSSD, pNN50) and frequency-domain indices (LF, HF, LF/HF ratio) are analyzed to reflect sympathetic and parasympathetic modulation. Higher RMSSD, pNN50, and HF values indicate greater parasympathetic activity.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, and Fatigue Among Individuals With Poor Sleep Quality: Evidence for Autonomic Nervous System Modulation

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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