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

N/ANot Yet RecruitingNCT07533097

Rabia Atilla80 enrolled

Overview

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.

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'.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Hot Flashes Climactericum Perimenopausal Depression Cold Application Acupoints

Interventions

Cold gel packs applicationBEHAVIORAL

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.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Başkent Üniversitesi Hastanesi

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Menopause-Specific Hot Flash Scale

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.

Time frame: From enrollment to the end of treatment at 4 weeks

Perimenopausal Depression Rating Scale

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.

Time frame: From enrollment to the end of treatment at 4 weeks

Data from ClinicalTrials.gov

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