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Набор скоро начнётся NCT07533097

The Effect of Cold Packs on Hot Flushes and Depression in Women Going Through the Climacteric Period

Без фазы С лечением Hot Flashes Climactericum Perimenopausal Depression Cold Application

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cold gel packs application.
Кому может быть актуально
Состояния в реестре: Hot Flashes, Climactericum, Perimenopausal Depression, Cold Application. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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 is planned to be conducted between 13 April 2026 and 13 September 2026 with 80 women (intervention group n=40, control group n=40) 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'.

Вмешательства

  • Поведенческое Cold gel packs application
    The women will apply a cold gel pack to the Sanyinjiao (SP6) and Hegu (Large Intestinal 4 (LI4)) acupoints located on the right and left sides of the body, which have been marked with a permanent marker by a specialist researcher. Each session will last a total of 30 minutes: 15 minutes on the SP6 acupoints followed by 15 minutes on the LI4 acupoints.This treatment will be carried out three times a week for four weeks, comprising a total of 12 sessions.

Первичные конечные точки

  • Menopause-Specific Hot Flash Scale [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Perimenopausal Depression Rating Scale [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Başkent Üniversitesi Hastanesi — Ankara

Идентификаторы

NCT: NCT07533097 · KA24/147

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗