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

NCT07533097 | Not Yet Recruiting

• 1 other identifier: KA24/147
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 LI4 and SP6 acupoints on hot flushes and depression in women during the climacteric period.

Conditions

Hot Flashes; Climactericum; Perimenopausal Depression; Cold Application; Acupoints

Keywords

Climacterium; hot flashes; perimenopausal depression; cold gel packs; cold application; LI4 acupoint; SP6 acupoint

Outcome Measures

Primary Outcomes (2)

• 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.

  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

Study Arms (2)

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) andHegu (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.

Behavioral: Cold gel packs application

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

Cold gel packs application BEHAVIORAL

The women will apply a cold gel pack to the SP6 and 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.

Experimental Group: Cold Gel Packs Application

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabia Atilla: lead

Study Sites (1)

Başkent Üniversitesi Hastanesi

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Experimental group: Cold gel packs Control group: No intervention

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): September 13, 2026
• Study Completion (Estimated): September 13, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)