The Effect of Acupressure on Menopausal Symptoms

Sponsor

Mersin University (Other)

Overall Status

Completed

CT.gov ID

NCT06016491

Collaborator

(none)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Menopause Acupressure	Behavioral: acupressure Behavioral: Sham acupressure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

81 people who attended the menopause school and met the inclusion criteria were selected by simple random sampling. Each of the women was allowed to draw from the numbers in the bell, and those who drew odd numbers were assigned to the placebo group, and those who drew even numbers were assigned to the acupressure group. Acupressure pressure point was applied to all women included in the study. Participants were blinded because they did not know whether the women were given acupressure or placebo acupressure. Researchers could not be blinded because they were also practitioners (Melek Yeşil Bayülgen and Fatma Hikmet Yeşil). When the research was completed, the data were analyzed by a statistician who did not know the groups and the findings were reported

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 5, 2021

Actual Primary Completion Date :

Aug 2, 2021

Actual Study Completion Date :

Mar 21, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Menopause Rating Scale (MRS) [Change from before implementation, 0th week and 4th week of practice]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mersin University	Mersin		Turkey

Sponsors and Collaborators

Mersin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melek Yesil Bayulgen, Lecturer (Principal Investigator), Mersin University

ClinicalTrials.gov Identifier:

NCT06016491

Other Study ID Numbers:

Mersin Univers

First Posted:

Aug 29, 2023

Last Update Posted:

Aug 29, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Melek Yesil Bayulgen, Lecturer (Principal Investigator), Mersin University

Menopause

Acupressure

Menopausal symptoms

Study Results

No Results Posted as of Aug 29, 2023