Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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'.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group: Cold Gel Packs Application | Experimental | 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. |
|
| Control Group | No Intervention | No intervention will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold gel packs application | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause-Specific Hot Flash Scale | The validity and reliability study of the scale in Turkish was conducted by DiÅŸli and Hotun Åžahin 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. | 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. | From enrollment to the end of treatment at 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Female
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent Üniversitesi Hastanesi | Ankara | Turkey (Türkiye) |
Patients will only be asked to consent to the use of their information within the scope of this study. Consent will not be required for the sharing of their information.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Experimental group: Cold gel packs Control group: No intervention
Not provided
Not provided
Not provided
|