Quality of Life Clinical Trial
Official title:
The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life
| 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 |
| Verified date | June 2022 |
| Source | Mersin University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Mersin University | Mersi?n |
| Lead Sponsor | Collaborator |
|---|---|
| Mersin University |
Turkey,
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
| 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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