Başkent Üniversitesi Hastanesi
Ankara, Turkey (Türkiye)
NCT Number: NCT07533097
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.
Trial opening soon.
Get NotifiedFemale
Interventional
Not applicable
Ankara, Turkey (Türkiye)
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'.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Rabia Atilla
Other
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
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