The Effect of Acupressure on Menopausal Symptoms

The Effect of Acupressure on Menopausal Symptoms: A Randomized, Sham Controlled Study

This is a prospective, randomized, placebo-controlled and single-blind study planned to determine the effect of acupressure application on menopausal symptoms.

The hypothesis of the study is that acupressure reduces women's menopausal symptoms.

Study Overview

• Status: Completed
• Conditions: Menopause; Acupressure
• Intervention / Treatment: Behavioral: acupressure; Behavioral: Sham acupressure

Detailed Description

Menopause is a physiological process during which most women have difficulties and face many problems. Acupressure can be taught and used safely as an effective method to manage the symptoms that women experience during menopause.

This study aims to determine the effect of acupressure on menopausal symptoms. The study has a prospective, randomized, sham-controlled, single-blind design. The research was conducted with 81 women (acupressure n=40, sham acupressure n=41) attending the "Menopause School" in a public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received acupressure application thrice a week for four weeks, 12 sessions in total. The data was obtained using a personal information form and a Menopause Rating Scale.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey
    • Mersin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to speak and understand Turkish
• No psychiatric illness
• Natural menopause
• Not on hormone replacement therapy
• Women who volunteered to participate in the study and did not receive any integrated therapy were included.

Exclusion Criteria:

• Those who have undergone menopause with the surgical method
• For lower extremity vascular disease, fracture, sprain or injury, diabetes, cardiovascular disease, thyroid disease, etc. with a diagnosis
• Women who received any integrative therapy were not included in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupressure group; Before the acupressure application, the woman to be applied was informed in a quiet room for ease of application, and then she was ensured to be in a comfortable position. Women were taught to practice on a total of two points, the kidney meridian (Yong Quan-KD1) and the spleen meridian (Sanyinjiao-SP6). Since the symmetry of the selected two different points on the other extremity will also be applied, a total of 8 minutes of compression was applied to each point, provided that it was two minutes. Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each patient, and then the patients were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks. To remind the session day, information was given by the researcher via short message.	Behavioral: acupressure; Depending on the preparation and compression time on each point, an average of 10 minutes was applied to each woman, and then the person were asked to apply it to themselves. After making sure that the women learned, they were asked to apply acupressure on their own. They applied a total of 12 sessions, three times a week for a total of four weeks.
Sham Comparator: Sham acupressure group; After all the preparations (suitability of sound and environment and information) before the application to the acupressure group were made in the sham group, the sham acupressure points determined parallel to the KD1 and SP6 points (approximately 1-1.5 cm away) were put on the bone area where the meridians do not pass has been applied. Similar to the acupressure group, the sham acupresuure group was treated with symmetrical extremities and for similar durations.	Behavioral: Sham acupressure; Compression was applied on the bone region where the meridians did not pass, parallel to the KD1 and SP6 points (approximately 1-1.5 cm away). Similar to the acupressure group, the sham group was treated with symmetrical extremities and for similar durati

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause Rating Scale (MRS)	Menopause symptom rating scale was used to evaluate menopausal symptoms. The Turkish reliability and validity study was conducted by Can (2005). The scale consists of 11 items and 3 sub-dimensions. For each item, there are "0=None", "1=Mild", "2=Moderate", "3=Severe" and "4=Very Severe" options. Sub-dimensions of the scale; somatic complaints (items 1,2,3 and 11), psychological complaints (items 4,5,6 and 7), and urogenital complaints (items 8,9 and 10). The total score of the scale ranges from 0 to 44. The somatic complaints sub-dimension is scored between 0-16, the psychological complaints sub-dimension 0-16, and the urogenital complaints sub-dimension 0-12. An increase in the total score obtained from the scale indicates that the severity of the complaints increases and the quality of life is negatively affected.	Change from before implementation, 0th week and 4th week of practice

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Menopause; Acupressure; Menopausal symptoms
• Other Study ID Numbers: Mersin Univers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No