NCT03915145

Brief Summary

The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 10, 2019

Last Update Submit

April 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The severity of menstrual pain assessed with Visual Analog Scale

    A 10-cm Visual Analog Scale anchored from zero (no pain at all) to 10 (the worst pain I have ever felt) was used to determine the severity of each subject's menstrual pain.

    An average of 2 weeks

Secondary Outcomes (2)

  • The complaints related to menstruation will be evaluated by a form prepared by the researchers

    An average of 2 weeks

  • The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory

    An average of 2 weeks

Study Arms (3)

Kinesio tape group

EXPERIMENTAL

Kinesio tape application has been applied

Other: Kinesio tape application

Sham group

SHAM COMPARATOR

Sham kinesio tape application has been applied

Other: Sham Kinesio tape application

Control group

OTHER

No intervention has been applied

Other: No intervention

Interventions

Kinesio tape application will be performed.Taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins

Kinesio tape group

Sham kinesio tape application will be performed. Sham taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins

Sham group

The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins

Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 35 years of age,
  • having Primary Dysmenorrhea
  • being volunteer women

You may not qualify if:

  • having give birth,
  • having a serious psychiatric disorder
  • having used oral contraceptive or depression drug in the last 6 month
  • having secondary dysmenorrhea
  • having irregular menstrual cycle
  • having allergy to taping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

  • Seyda TOPRAK CELENAY

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Basak Kavalci

    Gümüşhane Universıty

    STUDY CHAIR
  • Aysenur Karakus

    Ankara Yildirim Beyazıt University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

April 16, 2019

Study Start

March 10, 2019

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations