Complementary Alternative MedicineNCT07767318
Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms
A study testing Therapeutic Touch and Foot Reflexology in people with Complementary Alternative Medicine and Menopause, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was designed to compare the effects of therapeutic touch and reflexology on sleep quality and menopausal symptoms in postmenopausal women affected by the February 6, 2023 Kahramanmaraş earthquakes. Read more about this study
- Who is it for?
- Ages 45 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complementary Alternative Medicine, Menopause, Sleep Disturbance
- What is being tested?
- Therapeutic Touch and Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 45-64 years.
- Affected by the February 6, 2023 Kahramanmaraş earthquakes.
- Natural postmenopause (no spontaneous menstruation for at least 12 consecutive months).
- Living in the container settlement during the study period.
- Able to communicate in Turkish.
- Provided written informed consent.
Who cannot join
- History of surgical menopause.
- Current menopausal hormone therapy.
- Diagnosis of a psychiatric disorder.
- Use of antidepressants, benzodiazepines, hypnotics, narcotic analgesics, or antihistamines.
- Current use of Reiki, acupressure, phytoestrogens, or other complementary therapies.
- Foot wounds, infection, or open lesions preventing reflexology.
- Refusal to participate or withdrawal of consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms in Earthquake-affected Postmenopausal Women: A Randomized Controlled Trial
This randomized controlled trial was designed to compare the effects of therapeutic touch and reflexology on sleep quality and menopausal symptoms in postmenopausal women affected by the February 6, 2023 Kahramanmaraş earthquakes.
The study included 155 postmenopausal women assigned to therapeutic touch, reflexology, or control groups. Data were collected using the Participant Information Form, the Women's Health Initiative Insomnia Scale (WHIIS), and the Menopausal Symptom Assessment Scale (MSAS). The study evaluated sleep quality and menopausal symptoms at prespecified assessment points and compared changes in these outcomes among the study groups.
Read the detailed description
Natural disasters can have substantial effects on individual and public health. Türkiye is frequently exposed to earthquakes because of its location within the active Mediterranean-Alpine seismic belt. On February 6, 2023, two major earthquakes with magnitudes of 7.7 and 7.6 occurred in the Pazarcık and Elbistan districts of Kahramanmaraş, respectively. The earthquakes affected multiple provinces and disrupted access to healthcare and other essential services. Such disruptions may increase the healthcare needs of vulnerable populations, including women.
The health effects of disasters may vary according to the characteristics of the disaster, preparedness, access to healthcare services, and individual and community resilience. Postmenopausal women may have specific healthcare needs following disasters because menopause-related physiological changes can be accompanied by symptoms such as hot flashes, sleep disturbances, anxiety, and other physical and psychological complaints. Exposure to stressful events may also influence sleep and menopause-related health concerns.
Previous research on women's health following earthquakes has primarily focused on reproductive health, while information regarding menopausal symptoms and sleep problems among postmenopausal women exposed to disasters is limited. Therefore, assessment of these health concerns and evaluation of interventions intended to address them are important for informing post-disaster healthcare practices.
Therapeutic touch is a noninvasive complementary practice involving the practitioner's use of the hands in relation to the individual's body. Reflexology is a complementary practice involving the application of pressure to specific reflex areas, particularly on the feet. Both approaches have been investigated in different populations in relation to symptoms such as stress, sleep disturbances, and menopause-related complaints.
This randomized controlled trial was designed to compare therapeutic touch, reflexology, and a control condition with respect to sleep quality and menopausal symptoms among postmenopausal women affected by the February 6, 2023 Kahramanmaraş earthquakes.
A total of 155 postmenopausal women were included in the study. Participants were assigned to therapeutic touch, reflexology, or control groups. Data were collected using the Participant Information Form, the Women's Health Initiative Insomnia Scale (WHIIS), and the Menopausal Symptom Assessment Scale (MSAS). Sleep quality and menopausal symptoms were assessed at prespecified time points.
The planned statistical analyses included descriptive statistics, Pearson chi-square test, one-way analysis of variance (ANOVA), paired-sample t-test, and repeated-measures analysis of covariance (ANCOVA). Pre-intervention scores and income level were included as covariates in the model, and Bonferroni correction was applied for pairwise comparisons. The analyses were planned to evaluate and compare changes in sleep quality and menopausal symptoms among the study groups.
- Being tested
- Therapeutic Touch, Foot Reflexology
- Keywords
- Menopausal Symptoms, Reflexology, Therapeutic Touch, Sleep Quality, Complementary and Alternative Medicine
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
Therapeutic Touch was administered twice weekly for four weeks (8 sessions). Each session lasted approximately 15 minutes and was delivered by a certified Therapeutic Touch practitioner.
Foot ReflexologyOther
Foot reflexology was administered twice weekly for four weeks (8 sessions). Each session lasted approximately 30 minutes and was delivered by a certified reflexologist.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Touch Group | Experimental | Participants in the therapeutic touch group received a total of eight sessions of therapeutic touch twice a week for four weeks, in accordance with the standard application protocol recommended in the relevant literature. Each session lasted approximately 15 minutes 24,31. The applications were planned taking into account the days and times convenient for the participants and were performed by the researcher who had completed the first and second level therapeutic touch training organized by the Therapeutic Touch International Association and was entitled to receive certification.
Participants in the reflexology group received a total of eight sessions of foot reflexology twice a week for four weeks, in accordance with the standard reflexology protocol. Each session lasted approximately 30 minutes. The applications were planned taking into account the days and times convenient for the participants and were performed by the researcher who had a Ministry of Health-approved reflexologist Receives: Other: Therapeutic Touch |
| Reflexology Group | Experimental | Foot reflexology treatments were performed by a researcher holding a Ministry of Health-approved Reflexologist Practitioner certificate. Prior to the treatment, participants' feet were assessed for the presence of wounds, infections, edema, or open lesions. Participants deemed suitable were positioned supine or semi-sitting. After cleaning and relaxing the feet with a suitable massage oil, manual pressure was applied to the solar plexus, pituitary gland, pineal gland, kidney, adrenal gland, heart, lungs, stomach, liver/spleen, ovaries, and uterus reflex points using toe-walking and pressure techniques according to the standard reflexology protocol. The session was concluded with relaxing stroking movements. Each session consisted of 15 minutes of reflexology applied to each foot, for a total of 30 minutes. Treatments were performed twice a week for four weeks, with each participant receiving a total of eight sessions. Receives: Other: Foot Reflexology |
| Control Group | No intervention | Participants in the control group received no intervention during the four-week study period. Following the completion of the final test assessments, participants who requested it received two sessions of therapeutic touch or foot reflexology as an ethical measure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality will be assessed using the Women's Health Initiative Insomnia Rating Scale (WHIIRS). The total score ranges from 0 to 20, with higher scores indicating greater severity of insomnia symptoms and poorer sleep quality.
Measured: Baseline and Week 4
Secondary outcomes (1)
Postmenopausal Symptoms
Postmenopausal Symptoms
Postmenopausal symptoms will be assessed using the Menopause Rating Scale (MRS). The total score ranges from 0 to 44, with higher scores indicating greater severity of menopausal symptoms and therefore a worse outcome.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start15 Aug 2025
- Primary completion15 Jan 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complementary Alternative MedicineStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CANSU AĞRALI, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767318
- Sponsor's protocol ID
- 2024/03
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms in Earthquake-affected Postmenopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07767318
- Acronym / sponsor ID
- 2024/03
- Keywords
- Menopausal Symptoms, Reflexology, Therapeutic Touch, Sleep Quality, Complementary and Alternative Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 17 Aug 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.
This randomized controlled trial was designed to compare the effects of therapeutic touch and reflexology on sleep quality and menopausal symptoms in postmenopausal women affected by the February 6, 2023 Kahramanmaraş earthquakes.
The study included 155 postmenopausal women assigned to therapeutic touch, reflexology, or control groups. Data were collected using the Participant Information Form, the Women's Health Initiative Insomnia Scale (WHIIS), and the Menopausal Symptom Assessment Scale (MSAS). The study evaluated sleep quality and menopausal symptoms at prespecified assessment points and compared changes in these outcomes among the study groups.
Detailed description
Natural disasters can have substantial effects on individual and public health. Türkiye is frequently exposed to earthquakes because of its location within the active Mediterranean-Alpine seismic belt. On February 6, 2023, two major earthquakes with magnitudes of 7.7 and 7.6 occurred in the Pazarcık and Elbistan districts of Kahramanmaraş, respectively. The earthquakes affected multiple provinces and disrupted access to healthcare and other essential services. Such disruptions may increase the healthcare needs of vulnerable populations, including women.
The health effects of disasters may vary according to the characteristics of the disaster, preparedness, access to healthcare services, and individual and community resilience. Postmenopausal women may have specific healthcare needs following disasters because menopause-related physiological changes can be accompanied by symptoms such as hot flashes, sleep disturbances, anxiety, and other physical and psychological complaints. Exposure to stressful events may also influence sleep and menopause-related health concerns.
Previous research on women's health following earthquakes has primarily focused on reproductive health, while information regarding menopausal symptoms and sleep problems among postmenopausal women exposed to disasters is limited. Therefore, assessment of these health concerns and evaluation of interventions intended to address them are important for informing post-disaster healthcare practices.
Therapeutic touch is a noninvasive complementary practice involving the practitioner's use of the hands in relation to the individual's body. Reflexology is a complementary practice involving the application of pressure to specific reflex areas, particularly on the feet. Both approaches have been investigated in different populations in relation to symptoms such as stress, sleep disturbances, and menopause-related complaints.
This randomized controlled trial was designed to compare therapeutic touch, reflexology, and a control condition with respect to sleep quality and menopausal symptoms among postmenopausal women affected by the February 6, 2023 Kahramanmaraş earthquakes.
A total of 155 postmenopausal women were included in the study. Participants were assigned to therapeutic touch, reflexology, or control groups. Data were collected using the Participant Information Form, the Women's Health Initiative Insomnia Scale (WHIIS), and the Menopausal Symptom Assessment Scale (MSAS). Sleep quality and menopausal symptoms were assessed at prespecified time points.
The planned statistical analyses included descriptive statistics, Pearson chi-square test, one-way analysis of variance (ANOVA), paired-sample t-test, and repeated-measures analysis of covariance (ANCOVA). Pre-intervention scores and income level were included as covariates in the model, and Bonferroni correction was applied for pairwise comparisons. The analyses were planned to evaluate and compare changes in sleep quality and menopausal symptoms among the study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch Group | Experimental | Other: Therapeutic TouchParticipants in the therapeutic touch group received a total of eight sessions of therapeutic touch twice a week for four weeks, in accordance with the standard application protocol recommended in the relevant literature. Each session lasted approximately 15 minutes 24,31. The applications were planned taking into account the days and times convenient for the participants and were performed by the researcher who had completed the first and second level therapeutic touch training organized by the Therapeutic Touch International Association and was entitled to receive certification. Participants in the reflexology group received a total of eight sessions of foot reflexology twice a week for four weeks, in accordance with the standard reflexology protocol. Each session lasted approximately 30 minutes. The applications were planned taking into account the days and times convenient for the participants and were performed by the researcher who had a Ministry of Health-approved reflexologist |
| Reflexology Group | Experimental | Other: Foot ReflexologyFoot reflexology treatments were performed by a researcher holding a Ministry of Health-approved Reflexologist Practitioner certificate. Prior to the treatment, participants' feet were assessed for the presence of wounds, infections, edema, or open lesions. Participants deemed suitable were positioned supine or semi-sitting. After cleaning and relaxing the feet with a suitable massage oil, manual pressure was applied to the solar plexus, pituitary gland, pineal gland, kidney, adrenal gland, heart, lungs, stomach, liver/spleen, ovaries, and uterus reflex points using toe-walking and pressure techniques according to the standard reflexology protocol. The session was concluded with relaxing stroking movements. Each session consisted of 15 minutes of reflexology applied to each foot, for a total of 30 minutes. Treatments were performed twice a week for four weeks, with each participant receiving a total of eight sessions. |
| Control Group | No intervention | –Participants in the control group received no intervention during the four-week study period. Following the completion of the final test assessments, participants who requested it received two sessions of therapeutic touch or foot reflexology as an ethical measure. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 45-64 years.
- Affected by the February 6, 2023 Kahramanmaraş earthquakes.
- Natural postmenopause (no spontaneous menstruation for at least 12 consecutive months).
- Living in the container settlement during the study period.
- Able to communicate in Turkish.
Key exclusion criteria (7 listed)
- History of surgical menopause.
- Current menopausal hormone therapy.
- Diagnosis of a psychiatric disorder.
- Use of antidepressants, benzodiazepines, hypnotics, narcotic analgesics, or antihistamines.
- Current use of Reiki, acupressure, phytoestrogens, or other complementary therapies.
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 |
|---|---|---|
| Therapeutic TouchTherapeutic Touch was administered twice weekly for four weeks (8 sessions). Each session lasted approximately 15 minutes and was delivered by a certified Therapeutic Touch practitioner. | Other | Therapeutic Touch Group |
| Foot ReflexologyFoot reflexology was administered twice weekly for four weeks (8 sessions). Each session lasted approximately 30 minutes and was delivered by a certified reflexologist. | Other | Reflexology Group |
Primary outcome
Sleep Quality
Time frame: Baseline and Week 4
Sleep quality will be assessed using the Women's Health Initiative Insomnia Rating Scale (WHIIRS). The total score ranges from 0 to 20, with higher scores indicating greater severity of insomnia symptoms and poorer sleep quality.
1 secondary outcome
Postmenopausal Symptoms
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- 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 Therapeutic Touch and Foot Reflexology in people with Complementary Alternative Medicine and Menopause, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.