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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04837729
Other study ID # 701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date November 15, 2021

Study information

Verified date June 2022
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this randomized controlled study, it was aimed to determine the effect of acupressure on menopausal symptoms and quality of life and the relationship between menopausal symptoms and quality of life. Three different hypothesis teams have been established for the study. These; H0: There is no significant difference between the menopause rating scores of the women in the study group in which acupressure was applied and the control group without acupressure. H1: There is a significant difference between the menopause rating scores of the women in the study group in which acupressure was applied and the control group without acupressure. H0: There is no significant difference between the quality of life scores of the women in the study group in which acupressure was applied and the control group without acupressure. H1: There is a significant difference between the quality of life scores of the women in the study group in which acupressure was applied and the control group without acupressure. H0: There is no relationship between menopause rating scores and quality of life scores of women in the study group in which acupressure was applied and in the control group without acupressure. H1: There is a relationship between menopause rating scores and quality of life scores of women in the study group in which acupressure was applied and in the control group without acupressure.


Description:

Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the acupressure without health risks by women may be effective in reducing the symptoms of menopause experienced by women and quality of life. In line with this information, it was aimed to determine the effect of acupressure on menopausal symptoms and quality of life and the relationship between menopausal symptoms and quality of life. The study will be carried out with menopausal women between the ages of 40-60 in Mersin province in Turkey. Therefore, in the study, 46 women in the menopausal period between the ages of 40-60 will be randomly assigned to acupressure and control groups. The study group (n = 23) will be applied to the determined points in a certain order. Sequence of application Large intestine 4th point (LI 4), Heart 7th point (HT 7), Triple warmer point 23 (TE 23), Stomach 36th point (ST 36), Spleen 6th point (SP 6) and Liver The 3rd point is (LV 3). Acupressure application for 20-25 minutes three times a week for four weeks will be applied individually to the study group. No intervention will be made to the control group for a period of four weeks. The primary expected outcome of the research is the effect of acupressure on menopausal symptoms of menopausal women. The second expected result of the study is to determine the effect of acupressure on quality of life. Results will be applied three times in total, before the study and control application, two weeks and 4 weeks later.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date November 15, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Willing to participate in research, - Can read and write in Turkish, - Open to communication, - Those who are between the ages of 40-60 and do not experience menstruation for at least one year, - Experiencing at least one or more of the menopausal symptoms, - Do not use medication for the treatment of menopausal symptoms, - No chronic disease, - Body mass index <30 kg / m2, - Not applying regular acupressure, - Those who have not surgically entered menopause, - Women without psychiatric problems Exclusion Criteria: - - who do not agree to participate in the research, - Can't read and write Turkish, - Communication is not possible, - Those who are younger than 40, older than 60, have experienced menstruation for at least one year, - Do not experience the symptoms of menopause, - Using medication for the treatment of menopausal symptoms, - Chronic illness, - Body mass index =30 kg / m2, - Regular acupressure is applied, - Surgically in menopause, - Women with psychiatric problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupressure
acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians.

Locations

Country Name City State
Turkey Mersin University Mersi?n

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ahmadinezhad M, Kargar M, Vizeshfar F, Hadianfard MJ. Comparison of the Effect of Acupressure and Pilates-Based Exercises on Sleep Quality of Postmenopausal Women: A Randomized Controlled Trial. Iran J Nurs Midwifery Res. 2017 Mar-Apr;22(2):140-146. doi: 10.4103/1735-9066.205954. — View Citation

Kao YH, Huang YC, Chung UL, Hsu WN, Tang YT, Liao YH. Comparisons for Effectiveness of Aromatherapy and Acupressure Massage on Quality of Life in Career Women: A Randomized Controlled Trial. J Altern Complement Med. 2017 Jun;23(6):451-460. doi: 10.1089/acm.2016.0403. Epub 2017 May 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Menopause Rating Scale It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44. change from before intervention, 2nd and 4th week of intervention
Secondary World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) Life of quality will be evaluated by using the WHOQOL-BREF-TR. This scale consists of 27 questions. There are a total of five areas in the scale: physical, mental, social, environmental and national environmental areas. Each area is evaluated within itself. The domain score is calculated with the score it gets from the questions that determine it. Field scores are evaluated between 4-20. Increasing score indicates goodness. Cronbach's alpha internal consistency coefficients of the scale; 0.83 in the physical area, 0.66 in the spiritual area, 0.53 in the social area, 0.73 in the environmental area and 0.73 in the national environmental area. change from before intervention, 2nd and 4th week of intervention
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