The Effect of Acupressure on Menopausal Symptoms

NCT06016491 | Completed

• 1 other identifier: Mersin Univers
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Acupressure

Keywords

Menopause; Acupressure; Menopausal symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Acupressure group

EXPERIMENTAL

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

Sham acupressure group

SHAM COMPARATOR

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

Interventions

acupressure BEHAVIORAL

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.

Acupressure group

Sham acupressure BEHAVIORAL

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

Sham acupressure group

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer (Principal Investigator)

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 29, 2023
• Study Start: July 5, 2021
• Primary Completion: August 2, 2021
• Study Completion: March 21, 2022
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)