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NCT Number: NCT05909956

Effects of Therapeutic Tapping in Primary Dysmenorrhea

Dysmenorrhea is more common among women of reproductive age, as it affects their quality of life and limit their daily activities and normal functioning. The estimates of dysmenorrhea from research conducted all around the world varied widely, from 20% to 90%. This study is planned to determine the effects of KT on clinical symptoms, QOL and academic performance of students with Primary dysmenorrhea.

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Key information

Conditions

Primary Dysmenorrhea

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Iman girl hostels

Islamabad, 46000, Pakistan

About this study

Literature suggested that kinesio tape technique, one of the effective physiotherapy technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled trial, with three groups.

Participants in the experimental group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament with general physical therapy session. Sham group (ST) group will receive sham taping with general physical therapy session. Participants in Control group (CG) will receive only general physical therapy session.

All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL and academic performance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous women with Primary dysmenorrhea
  • Aged between 18 and 25 years.
  • Having a regular menstruation cycle (28 ± 7 days)
  • Severity of menstrual pain on VAS: 4 and over in the previous 6 months.

Exclusion criteria

  • Secondary dysmenorrhea
  • Childbirth, pelvic surgery, use of an intrauterine device,
  • Malignant condition
  • Chronic medication; antidepressants or oral contraceptives for at least 6 months prior to study
  • Not volunteering to participate in the study
  • Having an allergy to K.

Treatment and study plan

Kinesiotape

Other

The kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle)

Sham Tape

Other

This group will receive KT tapping without stretch on the sacral and suprapubic region.

General Physio session

Other

General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck & upper trapezius, arm & shoulder girdle, triceps brachii, teres major & minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day.

Primary outcomes

  1. Visual Analog Scale

    Time frame: Changes from Baseline to 8th week

    It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.

  2. Visual Analog Scale

    Time frame: Changes from 8th week to 12th week

    It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients with primary dysmenorrhea.

  3. Menstrual Symptom Questionnaire

    Time frame: Changes from Baseline to 8th week

    The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.

  4. Menstrual Symptom Questionnaire

    Time frame: Changes from 8th week to 12th week

    The Menstrual Symptom Questionnaire, a psychometric test, underwent a correlational analysis to determine test-retest reliability. All the items had reliability coefficients equal to or greater than 0.648, and the average coefficient based on Z-score transformation 0.78. It will be used to measure the severity of dysmenorrhea symptoms.

  5. Health-related life quality

    Time frame: Changes from Baseline to 8th week

    Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.

  6. Health-related life quality

    Time frame: Changes from 8th week to 12th week

    Health-related life quality using the Short Form-36 will be used to measure the pre-post quality of life of the participants and it's a valid and reliable tool used in majority of researches to measure the quality of life.

Secondary outcomes

  1. Self-Structured 20-items Academic Performance questionnaire

    Time frame: Changes from Baseline to 8th week

    It is a 20 items questionnaire, divided under 5 subheadings, in a form of check list "yes or No" response, was developed to measure the impacts of menstrual symptoms on academic performance.

  2. Self-Structured 20-items Academic Performance questionnaire

    Time frame: Changes from 8th week to 12th week

    It is a 20 items questionnaire, divided under 5 subheadings, in a form of check list "yes or No" response, was developed to measure the impacts of menstrual symptoms on academic performance.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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