The Effect of Cold Packs on Hot Flushes and Depression in Women Going Through the Climacteric Period
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorRabia Atilla
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Cold gel packs application
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental Group: Cold Gel Packs ApplicationExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rabia Atilla
Lead sponsor
Nigde Omer Halisdemir University
Sponsor institution
Source ClinicalTrials.gov
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