Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms

NCT07767318 | Completed

• 1 other identifier: 2024/03
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Complementary Alternative Medicine; Menopause; Sleep Disturbance

Keywords

Menopausal Symptoms; Reflexology; Therapeutic Touch; Sleep Quality; Complementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 4

Secondary Outcomes (1)

• Postmenopausal Symptoms

  Baseline and Week 4

Study Arms (3)

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

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.

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.

Interventions

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.

Therapeutic Touch Group

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.

Reflexology Group

Eligibility Criteria

• Age: 45 Years - 64 Years
• Gender Eligibility Details: Only postmenopausal women aged 45-64 years who were affected by the February 6, 2023 Kahramanmaraş earthquakes were eligible to participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osmaniye Korkut Ata University: lead

Study Sites (1)

İnönü Üniversitesi

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor/lecturer

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 17, 2026
• Study Start: August 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: August 1, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)