NCT04320641

Brief Summary

The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 23, 2020

Last Update Submit

March 23, 2020

Conditions

Premenstrual SyndromeNursing Caries

Keywords

PMS,YOGANURSINGHEALTH QUALITY

Outcome Measures

Primary Outcomes (2)

  • premenstrual syndrome scale

    12 weeks

  • WHOQOL-BREF-TR

    12 weeks

Study Arms (3)

acupressure

EXPERIMENTAL
Other: ACUPRESSURE

music

EXPERIMENTAL
Other: ACUPRESSURE

control

NO INTERVENTION

Interventions

ACUPRESSUREOTHER

Acupressure points were determined in a certain order considering the direction of the meridian. The order of application was in the form of Spleen 6th point (SP 6) and 4 point of the Large Intestine (Li 4). In total, 4 points in the upper / lower extremities and 6 acupressure points along with parallel points were studied in each attempt.

Also known as: YOGA
acupressuremusic

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have regular menstrual cycle

You may not qualify if:

  • Has a psychiatric diagnosis,
  • Having any gynecological disease (anornal uterine bleeding, fibroids, ovarian cyst etc.)
  • Using contraceptive drugs,
  • With tissue deformity in its extremities, Any health problems that may prevent physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Didem Simsek Kucukkelepce

Adi̇yaman, 02100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

AcupressureYoga

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMind-Body TherapiesSpiritual TherapiesExercise Movement Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
* who do not have regular periods (between 21-35 days), * Has a psychiatric diagnosis, * Having any gynecological disease (anornal uterine bleeding, fibroids, ovarian cyst etc.) * Using contraceptive drugs, * With tissue deformity in its extremities, Any health problems that may prevent physical exercise
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Didem Kucukkelepce

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

February 15, 2019

Primary Completion

July 30, 2019

Study Completion

January 10, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)