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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Poor Sleep Quality
• Intervention / Treatment: Behavioral: manual reflexology treatment; Behavioral: Feet massage using an electric massager (FEM)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112303
    • National Taipei University of Nursing and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. . Aged between 40 and 80 years.
2. . Had no prior experience with, or had not regularly received, feet massage treatments.
3. . Had a global score greater than 10 on the PSQI, indicating poor sleep quality.

Exclusion Criteria:

1. . Presence of bacterial or viral infections on the feet.
2. . Acute infectious diseases, bleeding or coagulation disorders, psychiatric conditions, open wounds, or bone fractures.
3. . Conditions such as extreme fatigue, physical weakness, alcohol intoxication, or long-term bedridden status that prevented attendance at the study site.
4. . Lower limb amputation or significant limb deficiency.
5. . Employment involving rotating or shift work.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: manual reflexology treatment; Participants assigned to the manual reflexology treatment arm receive a structured, therapist-delivered foot reflexology intervention administered once weekly for 6 weeks. Each session lasts approximately 30-40 minutes and follows a standardized protocol based on predefined reflex zones of both feet. The intervention includes systematic relaxation techniques, stimulation of whole-foot reflex areas, and targeted reinforcement of reflex zones associated with sleep regulation and autonomic nervous system function. All treatments are delivered by a certified reflexology practitioner in a quiet, controlled environment, with procedures standardized according to the Template for Intervention Description and Replication (TIDieR) framework to ensure consistency and reproducibility.	Behavioral: manual reflexology treatment; 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/; Behavioral: Feet massage using an electric massager (FEM); 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.
Active Comparator: mechanical foot massage; The participants received feet massage using an electric massager (Model HY-703, HUEI YEH, Taipei, Taiwan). 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.	Behavioral: manual reflexology treatment; 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/; Behavioral: Feet massage using an electric massager (FEM); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	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.	Baseline and after 6 weeks of each intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	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.	Baseline and after 6 weeks of each intervention period
Fatigue Severity	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.	Baseline and after 6 weeks of each intervention period
Autonomic Nervous System Function (Heart Rate Variability)	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.	Baseline and immediately after intervention at week 1 and week 6 of each intervention period

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences

Publications and helpful links

General Publications

• Cai DC, Chen CY, Lo TY. Foot Reflexology: Recent Research Trends and Prospects. Healthcare (Basel). 2022 Dec 20;11(1):9. doi: 10.3390/healthcare11010009.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Autonomic nervous system; Foot reflexology; Heart rate variability; Pittsburgh Sleep Quality Index; Poor sleep quality
• Other Study ID Numbers: C113172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No