Comparative Effects of Therapeutic Touch and Foot Reflexology on Sleep Quality and Menopausal Symptoms in Earthquake-affected Postmenopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Therapeutic Touch (Other)
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.
干预措施: Foot Reflexology (Other)
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.
结局指标
主要结局
Sleep Quality
时间窗: 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.
次要结局
- Postmenopausal Symptoms(Baseline and Week 4)
研究者
CANSU AĞRALI
doctor/lecturer
Osmaniye Korkut Ata University