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

• ClinicalTrials.gov Identifier: NCT04837729
• Recruitment Status: Enrolling by invitation
• First Posted: April 8, 2021
• Last Update Posted: September 28, 2021
• Sponsor: Mersin University
• Information provided by (Responsible Party): Ahu AKSOY, Mersin University

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
Menopausal Symptom; Quality of Life	Other: Acupressure	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 46 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: February 15, 2021
• Estimated Primary Completion Date: January 15, 2022
• Estimated Study Completion Date: June 15, 2022

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 [ 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women aged 40-60 who are in menopause
• Accepts Healthy Volunteers: Yes

Criteria

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

Turkey

Mersin University

Yenişehir, Mersi̇n, Turkey, 33140

Sponsors and Collaborators

Mersin University

Investigators

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

More Information

Additional Information:

Effect of acupressure on early complications of menopause in women referring to selected health care centers 

Effect of Auricular Acupressure on Peri- and Early Postmenopausal Women with Anxiety: A Double-Blinded, Randomized, and Controlled Pilot Study 

Publications:

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.

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.

• Responsible Party: Ahu AKSOY, Research Assistant, Mersin University
• ClinicalTrials.gov Identifier: NCT04837729
• Other Study ID Numbers: 701
• First Posted: April 8, 2021
• Last Update Posted: September 28, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• 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, Mersin University:

Acupressure; Menopause; Menopausal symptoms; Quality of life; Nursing