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Completed

NCT Number: NCT07767318

Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms

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.

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Key information

Age range

45 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İnönü Üniversitesi

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Therapeutic Touch

Other

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 reflexology

Other

Foot reflexology was administered twice weekly for four weeks (8 sessions). Each session lasted approximately 30 minutes and was delivered by a certified reflexologist.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postmenopausal Symptoms

    Time frame: Baseline and Week 4

    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.

Sponsors and collaborators

Lead sponsor

Osmaniye Korkut Ata University

Other

Registry information

Official study title

Comparative Effects of Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms in Earthquake-affected Postmenopausal Women: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 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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