NCT06990815

Brief Summary

Primary dysmenorrhea is characterized by recurrent, cramping lower abdominal pain during menstruation and affects approximately 50% to 90% of women. The etiology of primary dysmenorrhea involves the increased release of prostaglandins and other inflammatory mediators, which cause uterine contractions and reduced blood flow. In addition to pharmacological approaches, non-pharmacological methods also play an important role in the treatment of dysmenorrhea. Kinesio taping helps relieve pain by reducing pressure on the muscle and supports treatment through various application techniques. It improves local circulation, reduces muscle tension, and alleviates symptoms of primary dysmenorrhea. The aim of this study is to investigate the effects of kinesio taping on pain, menstrual symptoms, fear of movement, and sleep quality in women with primary dysmenorrhea, and to compare the outcomes with those of a sham taping group. The hypothesis is that kinesio taping will be more effective than sham taping in improving these parameters in women with primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 19, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

May 17, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

Kinesio TapingPainMenstrual SymptomsFear of MovementSleep Quality

Outcome Measures

Primary Outcomes (5)

  • Visual Analog Scale

    Pain will be assessed using the Visual Analog Scale. On the Visual Analog Scale, a score of '0' indicates no pain, while '10' represents the most unbearable pain on a 10 cm horizontal line. It is a simple, practical, valid, reliable, and reproducible measurement tool.

    2 weeks

  • Menstrual Symptom Questionnaire

    The Menstrual Symptom Questionnaire (MSQ) was originally developed by Chesney and Tasto in 1975 to evaluate menstrual pain and related symptoms. Participants rate the severity of symptoms they experience during menstruation on a scale from 1 (never) to 5 (always). In this scale: Items 1-13 assess negative effects, Items 14-19 assess menstrual pain symptoms, and Items 20-22 assess coping methods. As the average score of each subscale increases, it indicates a higher severity of menstrual symptoms related to that subscale.

    2 weeks

  • Menstrual Attitude and Behavior Scale

    The Menstrual Attitude and Behavior Scale will be used to assess individuals' attitudes and behaviors during the menstrual period. This scale, also known as the Menstrual Attitude Questionnaire, consists of 33 items divided into five subscales: Menstruation as a debilitating event - 12 items Menstruation as a bothersome event - 6 items Menstruation as a natural event - 5 items Anticipation of the onset of menstruation - 5 items Denial of menstrual effects - 7 items Each subscale provides insight into specific attitudes and perceptions related to menstruation.

    2 weeks

  • Tampa Scale of Kinesiophobia

    Fear of movement will be assessed using the Tampa Scale of Kinesiophobia. The scale uses a 4-point Likert-type scoring system, and the total score ranges from 17 to 68. Higher scores indicate a greater fear of movement.

    2 weeks

  • Richard Campbell Sleep Questionnaire

    The Richard Campbell Sleep Questionnaire was developed by Richards in 1987 to assess sleep depth, time taken to fall asleep, number of awakenings, duration of wakefulness after sleep onset, sleep quality, and environmental noise level. It consists of 6 items, each evaluated using a visual analog scale ranging from 0 to 100. A score between 0-25 indicates very poor sleep, while a score between 76-100 reflects very good sleep. The total score is calculated based on 5 items; the 6th item, which evaluates environmental noise level, is excluded from the total score. Higher total scores indicate better sleep quality.

    2 weeks

Study Arms (2)

Kinesio Taping Group

EXPERIMENTAL
Other: Kinesio Taping

Sham Control Group

SHAM COMPARATOR
Other: Sham

Interventions

In the application over the sacrum, one I-strip of kinesio tape will be applied with 25% tension using the fascia correction technique, which requires oscillatory movements between the tape and the skin. In the application over the suprapubic region, two I-strips will be applied with 25% tension, also using the fascia correction technique, involving oscillations between the tape and the skin.

Kinesio Taping Group
ShamOTHER

In the application over the sacrum, one I-strip will be applied without tension. In the application over the suprapubic region, two I-strips will be placed without tension.

Sham Control Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing a nulliparous woman aged between 18 and 24 years
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being a nulliparous woman aged between 18 and 24 years
  • Having a diagnosis of primary dysmenorrhea confirmed by a physician,
  • Being literate
  • Cooperating in completing the assessment scales
  • Scoring one or above on the Weissman Scale
  • Agreeing to participate in the study
  • Having regular menstruation in the last 6 months
  • Being willing and voluntary to participate in the research.

You may not qualify if:

  • Having a diagnosis of secondary dysmenorrhea
  • Using contraceptive pills
  • Having a history of childbirth or pregnancy
  • Having irregular menstrual cycles (menstrual cycle length less than 21 days or longer than 35 days)
  • Having any pelvic pathology or history of pelvic surgery
  • Having gastrointestinal, urogynecological, autoimmune, psychiatric, neurological diseases, or other chronic pain syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainKinesiophobiaSleep Initiation and Maintenance Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 25, 2025

Study Start

August 19, 2023

Primary Completion

December 15, 2023

Study Completion

December 23, 2023

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations