Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye)
- İnönü Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Therapeutic Touch Group
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 |
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.
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Experimental: Reflexology Group
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.
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Foot reflexology was administered twice weekly for four weeks (8 sessions).
Each session lasted approximately 30 minutes and was delivered by a certified reflexologist.
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Quality
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postmenopausal Symptoms
Time Frame: Baseline and Week 4
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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. |
Baseline and Week 4
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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