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

Sponsor
Mersin University (Other)
Overall Status
Completed
CT.gov ID
NCT04837729
Collaborator
(none)
61
1
2
6
10.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Acupressure
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life
Actual Study Start Date :
May 15, 2021
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Menopause Rating Scale [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.

Secondary Outcome Measures

  1. World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mersin University Mersi̇n Turkey 33140

Sponsors and Collaborators

  • Mersin University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ahu AKSOY, Research Assistant, Mersin University
ClinicalTrials.gov Identifier:
NCT04837729
Other Study ID Numbers:
  • 701
First Posted:
Apr 8, 2021
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahu AKSOY, Research Assistant, Mersin University

Study Results

No Results Posted as of Jun 7, 2022