Menopausal SyndromeNCT04520542
The Effect of Acupressure Application on Menopausal Symptoms
A study testing Acupressure Application in people with Menopausal Syndrome, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome
- What is being tested?
- Acupressure Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2019to 25 Feb 2020
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in the 45-65 age range.
Who cannot join
- receiving pharmacological treatment related to menopause,
- having a communication problem,
- have a hearing problem
- It is the presence of tissue deformity in its extremities.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center.
Read the detailed description
Research, between September 2019 and February 2020 of cancer in the body healthy life center in the east of the provincial center of Turkey was held by early diagnosis and screening center that refer to women.
The Universe and Sample of the Research The universe of the study consisted of women who applied to cancer early diagnosis and screening center for examination for any reason.
The calculation of the sample size of the study was determined according to the studies in which non-pharmacological methods were used to cope with menopausal symptoms. The calculation was determined according to the effect size of 0.5 in a moderate level, considering the effect size ranging between (0.25-0.83) reported by the studies on the subject.
- Conditions
- Menopausal Syndrome
- Being tested
- Acupressure Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure ApplicationOther
Acupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. Each acupressure point was massaged for 30 seconds to provide circulation before the pressure. After the massage, consecutive pressures were applied for 90 seconds. In each intervention, a total of 8-minute sessions were applied to 4 points as 2 minutes for each point. Consecutive pressures were applied on a frequency that did not disturb the women, did not cause pain, and had a soothing effect. Until the end of the intervention it was continued 2 times a week, 16 times in total in 8 weeks. Receives: Other: Acupressure Application |
| Control Group | No intervention | no intervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Acupressure Application on Menopausal Symptoms
Menopause Rating Scale
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start5 Jun 2019
- Primary completion13 Sep 2019
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SyndromeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Kucukkelepce, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520542
- Sponsor's protocol ID
- Lokman Hekim Universty
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Application on Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT04520542
- Acronym / sponsor ID
- Lokman Hekim Universty
- Conditions
- Menopausal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 20 Aug 2020 (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.
The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center.
Detailed description
Research, between September 2019 and February 2020 of cancer in the body healthy life center in the east of the provincial center of Turkey was held by early diagnosis and screening center that refer to women.
The Universe and Sample of the Research The universe of the study consisted of women who applied to cancer early diagnosis and screening center for examination for any reason.
The calculation of the sample size of the study was determined according to the studies in which non-pharmacological methods were used to cope with menopausal symptoms. The calculation was determined according to the effect size of 0.5 in a moderate level, considering the effect size ranging between (0.25-0.83) reported by the studies on the subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: Acupressure ApplicationThe application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. Each acupressure point was massaged for 30 seconds to provide circulation before the pressure. After the massage, consecutive pressures were applied for 90 seconds. In each intervention, a total of 8-minute sessions were applied to 4 points as 2 minutes for each point. Consecutive pressures were applied on a frequency that did not disturb the women, did not cause pain, and had a soothing effect. Until the end of the intervention it was continued 2 times a week, 16 times in total in 8 weeks. |
| Control Group | No intervention | –no intervation |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in the 45-65 age range.
Key exclusion criteria (4 listed)
- receiving pharmacological treatment related to menopause,
- having a communication problem,
- have a hearing problem
- It is the presence of tissue deformity in its extremities.
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 |
|---|---|---|
| Acupressure ApplicationAcupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. | Other | acupressure |
Primary outcome
Effect of Acupressure Application on Menopausal Symptoms
Time frame: 8 week
Menopause Rating Scale
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 20 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Menopausal Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
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 Acupressure Application in people with Menopausal Syndrome, run by Adiyaman University Research Hospital 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 1 inclusion and 4 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 20 Aug 2020. 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?
Effect of Acupressure Application on Menopausal Symptoms (time frame: 8 week). 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 20 Aug 2020.