The Effect of Acupressure and Yoga on Premenstrual Sympto... | NCT04320641

Studies
The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life

NCT04320641

Sponsor

Adiyaman University Research Hospital

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

153Actual

Phase

Not Applicable

Conditions

Premenstrual Syndrome
Nursing Caries

Interventions

ACUPRESSURE

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2019Actual

Primary Completion Date

Jul 30, 2019Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Didem Kucukkelepce, Didem Kucukkelepce, Adiyaman University Research HospitalPrincipal Investigator

Lead Sponsor

Adiyaman University Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
acupressure	Experimental	Other: ACUPRESSURE
music	Experimental	Other: ACUPRESSURE
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACUPRESSURE	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
premenstrual syndrome scale		12 weeks
WHOQOL-BREF-TR		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have regular menstrual cycle

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Didem Simsek Kucukkelepce		Adi̇yaman		02100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011293	Premenstrual Syndrome

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019050	Acupressure
D015013	Yoga

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

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

Who Masked

Participant