The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life

June 3, 2022 updated by: Ahu AKSOY, Mersin University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersi̇n, Turkey, 33140
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental (acupressure) group
Acupressure (complementary and integrative medicine method) Acupressure will be applied individually to the experimental group for 20-25 minutes three times a week for four weeks. Data collection forms will be applied 3 times in total, before the intervention, in the second and the fourth week.
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.
No Intervention: Control group
No intervention will be made to women in the control group. However, data collection forms will be applied 3 times in total, before the intervention, in the second and the fourth week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menopause Rating Scale
Time Frame: change from before intervention, 2nd and 4th week of intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)
Time Frame: change from before intervention, 2nd and 4th week of intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Investigators

  • Study Director: Duygu VEFİKULUÇAY YILMAZ, Dr., Mersin University Nursing Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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