NCT04837729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

April 6, 2021

Last Update Submit

June 3, 2022

Conditions

Keywords

AcupressureMenopauseMenopausal symptomsQuality of lifeNursing

Outcome Measures

Primary Outcomes (1)

  • Menopause Rating Scale

    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.

    change from before intervention, 2nd and 4th week of intervention

Secondary Outcomes (1)

  • World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF)

    change from before intervention, 2nd and 4th week of intervention

Study Arms (2)

Experimental (acupressure) group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Experimental (acupressure) group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen aged 40-60 who are in menopause
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University

Mersin, 33140, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 28504569BACKGROUND
  • 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.

    PMID: 28584553BACKGROUND

Related Links

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Duygu VEFİKULUÇAY YILMAZ, Dr.

    Mersin University Nursing Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

May 15, 2021

Primary Completion

June 15, 2021

Study Completion

November 15, 2021

Last Updated

June 7, 2022

Record last verified: 2022-06

Locations