The Effect of Applying Cold Gel Packs to the LI4 and SP6 Acupoints on Menopausal Hot Flashes and Depression in Women During the Climacteric Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Menopause-Specific Hot Flash Scale
研究概览
简要总结
This study is planned as a pre-post test, randomised controlled, experimental trial designed to determine the effect of applying a cold gel pack to the Sanyinjiao (SP6) and Hegu (Large Intestinal 4 (LI4)) acupoints on hot flushes and depression in women during the climacteric period.
详细描述
Hot flushes, a vasomotor symptom of the climacteric period, are a common problem experienced by many women. It has been reported that in women who experience prolonged and severe hot flushes, daily activities are adversely affected and quality of life is impaired. Although hot flushes are not a life-threatening symptom, they lead to both physiological and psychological changes in the body. The literature contains evidence regarding the benefits of acupressure and cold applications in the management of menopausal symptoms. However, no study has been found regarding the application of cold to acupoints.
This study aims to determine the effect of applying a cold gel pack to the Sanyinjiao (SP6) and Hegu (Large Intestinal 4 (LI4)) acupoints on hot flushes and depression in women during the climacteric period.
The study employs a pre-test post-test design, randomised controlled, experimental study design.
The study i conducted between 13 April 2026 and 01 Agust 2026 with 60 women (intervention group n=30, control group n=30) who present to the gynaecology outpatient clinic of a foundation university hospital in Türkiye.
Women in the intervention group will self-administer cold gel packs to the LI4 and SP6 acupoints three times a week for four weeks, totalling 12 sessions. Data will be collected using an informed consent form, the 'Perimenopausal Depression Assessment Scale' and the 'Menopause-Specific Hot Flash Scale'.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In the perimenopausal phase (no menstruation for 3-11 months or an increase in irregular menstrual bleeding) or the postmenopausal phase (no menstruation for more than 12 months),
- •Participants experiencing moderate to severe hot flushes at least four times a day in the week prior to enrolment,
- •Participants who are literate in Turkish and able to communicate,
- •Participants who volunteer to take part in the study will be included in the study.
排除标准
- •Women who have entered menopause following surgery,
- •Women whose hot flush symptoms have decreased or ceased in the week prior to joining the study,
- •Those receiving hormone replacement therapy,
- •Those who had received herbal medication (such as black cohosh, black cohosh, ginkgo, ginseng, motherwort, valerian, black snake root, St. John's wort, etc.) or chemical medication for at least two weeks prior to joining the study,
- •Women with endocrine system disorders such as diabetes or a condition presenting symptoms similar to hot flushes,
- •Women with a regular menstrual cycle,
- •Women with a psychiatric diagnosis who are currently receiving treatment,
- •Women taking sleeping pills,
- •Women with a language barrier preventing communication in Turkish,
- •Women who are not willing to participate in the study will not be included in the research.
研究组 & 干预措施
Experimental Group: Cold Gel Packs Application
Women in the experimental group will apply cold gel packs to the acupoints located on the right and left sides of their bodies Sanyinjiao (SP6) and Hegu (Large Intestinal 4 (LI4)) for 15 minutes each, simultaneously, for a total of 30 minutes. This treatment will be administered over four weeks, comprising a total of 12 sessions, three days a week. Prior to the treatment, the acupoints on the woman's hands and legs will be identified by a researcher who has completed a course in 'acupressure' and marked with a permanent marker. The treatment steps, developed in accordance with the literature, will be explained in detail.
It will be emphasized that cold gel packs should be kept in the freezer compartment of the refrigerator for at least 2 hours before application, and that they should be removed and placed in a protective cover before application. A reminder message will be sent to the woman by the researcher before the session.
干预措施: Cold gel packs application (Behavioral)
Control Group
No intervention will be applied.
结局指标
主要结局
Menopause-Specific Hot Flash Scale
时间窗: From enrollment to the end of treatment at 4 weeks
The validity and reliability study of the scale in Turkish was conducted by Dişli and Hotun Şahin in 2022. The scale consists of 10 items. This scale is used to assess the extent to which the hot flushes experienced by the participant over the past two weeks have affected their life. The first nine items of the scale assess the impact of hot flushes on nine specific areas of life: work life, social activities, leisure activities, sleep, emotional state, concentration, relationships with others, sexuality, and enjoyment of life; the tenth item assesses the impact of hot flushes on the participant's quality of life. The scale score is obtained by summing the scores given for each item (on a scale of 0-100). As the scale score approaches 100, the extent to which the woman is affected by hot flushes increases.
Perimenopausal Depression Rating Scale
时间窗: From enrollment to the end of treatment at 4 weeks
The scale was developed to assess the severity of perimenopausal depression symptoms. It consists of 12 items and five subscales. A score ranging from a minimum of 0 to a maximum of 48 can be obtained on the scale. As the score on the scale increases, the severity of depression increases. A score of 20-24 indicates mild perimenopausal depression, a score of 24-32 indicates moderate perimenopausal depression requiring treatment, and a score of 32 or above indicates severe perimenopausal depression requiring treatment.
次要结局
未报告次要终点
研究者
Rabia Atilla
Assistant Professor
Nigde Omer Halisdemir University