Hot FlashesNCT07533097
The Effect of Cold Packs on Hot Flushes and Depression in Women Going Through the Climacteric Period
A study testing Cold gel packs application in people with Hot Flashes and Climactericum, run by Rabia Atilla at 1 site in Turkey (Türkiye).
Trial 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 Sanyinjiao (SP6) and Hegu (Large Intestinal 4 (LI4)) acupoints on hot flushes and depression in women during the climacteric period. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hot Flashes, Climactericum, Perimenopausal Depression
- What is being tested?
- Cold gel packs application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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 i conducted between 13 April 2026 and 01 Agust 2026 with 60 women (intervention group n=30, control group n=30) 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'.
- Being tested
- Cold gel packs application
- Keywords
- Climacterium, hot flashes, perimenopausal depression, cold gel packs, cold application, LI4 acupoint, SP6 acupoint
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold gel packs applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cold gel packs application |
| Control Group | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start13 Apr 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: Cold gel packs Control group: No intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabia Atilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rabia Atilla, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533097
- Sponsor's protocol ID
- KA24/147
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07533097
- Acronym / sponsor ID
- KA24/147
- Keywords
- Climacterium, hot flashes, perimenopausal depression, cold gel packs, cold application, LI4 acupoint, SP6 acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rabia AtillaUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 i conducted between 13 April 2026 and 01 Agust 2026 with 60 women (intervention group n=30, control group n=30) 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental group: Cold gel packs Control group: No intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Cold Gel Packs Application | Experimental | Behavioral: Cold gel packs applicationWomen 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold gel packs applicationThe 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. | Behavioural | Experimental Group: Cold Gel Packs Application |
Primary outcome
Menopause-Specific Hot Flash Scale
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.
Perimenopausal Depression Rating Scale
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold gel packs application in people with Hot Flashes and Climactericum, run by Rabia Atilla at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause-Specific Hot Flash Scale (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.