Poor Sleep QualityNCT07402460
Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, Fatigue, and Heart Rate Variability Among Individuals With Poor Sleep Quality
A study testing manual reflexology treatment and Feet massage using an electric massager (FEM) in people with Poor Sleep Quality, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Poor Sleep Quality
- What is being tested?
- manual reflexology treatment and Feet massage using an electric massager (FEM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . 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.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei, 112303
About this study
Official 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
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)?
Read more
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.
Read the 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.
- Conditions
- Poor Sleep Quality
- Being tested
- manual reflexology treatment, Feet massage using an electric massager (FEM)
- Keywords
- Poor sleep quality, Pittsburgh Sleep Quality Index, Foot reflexology, Heart rate variability, Autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual reflexology treatmentBehavioural
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:
- 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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| manual reflexology treatment | Experimental | 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. Receives: Behavioral: manual reflexology treatment; Behavioral: Feet massage using an electric massager (FEM) |
| mechanical foot massage | Active comparator | 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. Receives: Behavioral: manual reflexology treatment; Behavioral: Feet massage using an electric massager (FEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 weeks of each intervention period
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after intervention at week 1 and week 6 of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Poor Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study employs a randomized crossover interventional study model. All participants receive both interventions-manual reflexology treatment and mechanical foot massage-administered in two separate intervention periods. The order of interventions is randomized to minimize order and carryover effects, allowing each participant to serve as their own control. Each intervention period lasts six weeks and is separated by a washout interval to reduce potential residual effects from the preceding intervention. This design enhances internal validity and enables direct comparison of the effects of the two interventions on sleep-related outcomes and autonomic nervous system function.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Ching Huang, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402460
- Sponsor's protocol ID
- C113172
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36611469Chen SP, Gao MH, Huang CC, Huang WC. Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, and Fatigue Among Individuals with Poor Sleep Quality: Evidence for Autonomic Nervous System Modulation. Complement Ther Med. 2026 Jul 31:103409. doi: 10.1016/j.ctim.2026.103409. Online ahead of print.
PubMed 42537947
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07402460
- Acronym / sponsor ID
- C113172
- Conditions
- Poor Sleep Quality
- Keywords
- Poor sleep quality, Pittsburgh Sleep Quality Index, Foot reflexology, Heart rate variability, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a randomized crossover interventional study model. All participants receive both interventions-manual reflexology treatment and mechanical foot massage-administered in two separate intervention periods. The order of interventions is randomized to minimize order and carryover effects, allowing each participant to serve as their own control. Each intervention period lasts six weeks and is separated by a washout interval to reduce potential residual effects from the preceding intervention. This design enhances internal validity and enables direct comparison of the effects of the two interventions on sleep-related outcomes and autonomic nervous system function.
| Arm | Type | Receives |
|---|---|---|
| manual reflexology treatment | Experimental | Behavioral: manual reflexology treatment, Behavioral: Feet massage using an electric massager (FEM)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. |
| mechanical foot massage | Active comparator | Behavioral: manual reflexology treatment, Behavioral: Feet massage using an electric massager (FEM)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- . 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.
Key exclusion criteria (5 listed)
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manual reflexology treatmentThe manual reflexology procedure was carried out following a standardized sequence, targeting specific foot reflex zones. The detailed steps were as follows: 1. 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. 2. Foot Relaxation Techniques: The treatment began with relaxation techniques (e.g., friction and oscillation) applied first to the left foot, followed by the right. 3. 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/ | Behavioural | manual reflexology treatment, mechanical foot massage |
| 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. | Behavioural | manual reflexology treatment, mechanical foot massage |
Primary outcome
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.
3 secondary outcomes
Insomnia Severity
Time frame: Baseline and after 6 weeks of each intervention period
Fatigue Severity
Time frame: Baseline and after 6 weeks of each intervention period
Autonomic Nervous System Function (Heart Rate Variability)
Time frame: Baseline and immediately after intervention at week 1 and week 6 of each intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 36611469Cai DC, Chen CY, Lo TY. Foot Reflexology: Recent Research Trends and Prospects. Healthcare (Basel). 2022 Dec 20;11(1):9. doi: 10.3390/healthcare11010009.
- Derived from this study: PubMed 42537947Chen SP, Gao MH, Huang CC, Huang WC. Effects of a Programmed Reflexology Therapy on Sleep Quality, Insomnia, and Fatigue Among Individuals with Poor Sleep Quality: Evidence for Autonomic Nervous System Modulation. Complement Ther Med. 2026 Jul 31:103409. doi: 10.1016/j.ctim.2026.103409. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual reflexology treatment and Feet massage using an electric massager (FEM) in people with Poor Sleep Quality, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Baseline and after 6 weeks of each intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07402460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.