NCT04520542

Brief Summary

The study was conducted randomly controlled to determine the effect of acupressure application on menopausal complaints among women who applied to Cancer Early Diagnosis and Screening Center.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 16, 2020

Last Update Submit

August 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of Acupressure Application on Menopausal Symptoms

    Menopause Rating Scale

    8 week

Study Arms (2)

acupressure

EXPERIMENTAL

The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention. Each acupressure point was massaged for 30 seconds to provide circulation before the pressure. After the massage, consecutive pressures were applied for 90 seconds. In each intervention, a total of 8-minute sessions were applied to 4 points as 2 minutes for each point. Consecutive pressures were applied on a frequency that did not disturb the women, did not cause pain, and had a soothing effect. Until the end of the intervention it was continued 2 times a week, 16 times in total in 8 weeks.

Other: Acupressure Application

Control Group

NO INTERVENTION

no intervation

Interventions

Acupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention.

acupressure

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in the 45-65 age range.

You may not qualify if:

  • receiving pharmacological treatment related to menopause,
  • having a communication problem,
  • have a hearing problem
  • It is the presence of tissue deformity in its extremities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Simsek Kucukkelepce

Adıyaman, 02100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lokman Hekim University

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 20, 2020

Study Start

June 5, 2019

Primary Completion

September 13, 2019

Study Completion

February 25, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations