Primary DysmenorrheaNCT03915145
The Effects of Kinesio Taping in Women With Primary Dysmenorrhea
A study testing Kinesio tape application in people with Primary Dysmenorrhea, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Kinesio tape application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2019to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 35 years of age,
- having Primary Dysmenorrhea
- being volunteer women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yildirim Beyazit University
Ankara
Aysenur Karakus
About this study
Official title: Assistant Professor, Physioterapist, PhD
The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Kinesio tape application, Sham Kinesio tape application, No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tape applicationOther
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
Sham Kinesio tape applicationOther
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
No interventionOther
The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
| Study group | Role | What they receive |
|---|---|---|
| Kinesio tape group | Experimental | Kinesio tape application has been applied Receives: Other: Kinesio tape application |
| Sham group | Sham comparator | Sham kinesio tape application has been applied Receives: Other: Sham Kinesio tape application |
| Control group | Other | No intervention has been applied Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 2 weeks
Secondary outcomes (2)
The complaints related to menstruation will be evaluated by a form prepared by the researchers
The form assessing the complaints related to menstruation will be evaluated existing complaints affect the patient and expressed as, no, little, mederate, very.
Measured: An average of 2 weeks
The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory
The Spielberger State Trait Anxiety Inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.). Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80. A higher total score indicates more severe anxiety level.
Measured: An average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start10 Mar 2019
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
- Investigators
- Seyda TOPRAK CELENAY, Principal investigator, Ankara Yildirim Beyazıt UniversityBasak Kavalci, Study chair, Gümüşhane UniversıtyAysenur Karakus, Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915145
- Sponsor's protocol ID
- 442-15
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Professor, Physioterapist, PhD
- ClinicalTrials.gov ID
- NCT03915145
- Acronym / sponsor ID
- 442-15
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio tape group | Experimental | Other: Kinesio tape applicationKinesio tape application has been applied |
| Sham group | Sham comparator | Other: Sham Kinesio tape applicationSham kinesio tape application has been applied |
| Control group | Other | Other: No interventionNo intervention has been applied |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 35 years of age,
- having Primary Dysmenorrhea
- being volunteer women
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tape applicationKinesio 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 | Other | Kinesio tape group |
| Sham Kinesio tape applicationSham 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 | Other | Sham group |
| No interventionThe natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins | Other | Control group |
Primary outcome
The severity of menstrual pain assessed with Visual Analog Scale
Time frame: An average of 2 weeks
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.
2 secondary outcomes
The complaints related to menstruation will be evaluated by a form prepared by the researchers
Time frame: An average of 2 weeks
The level of anxiety will be evaluated with The Spielberger State Trait Anxiety Inventory
Time frame: An average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda TOPRAK CELENAY principal investigator
Ankara Yildirim Beyazıt University
Basak Kavalci study chair
Gümüşhane Universıty
Aysenur Karakus study chair
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape application in people with Primary Dysmenorrhea, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda TOPRAK CELENAY (+90-534-041-3986, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of menstrual pain assessed with Visual Analog Scale (time frame: An average of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.