Effects of Therapeutic Tapping in Primary Dysmenorrhea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Primary Dysmenorrhea

Intervention / Treatment
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* Other: KinesioTape
* Other: Sham Tape
* Other: General Physio session


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT Group<br>This group will receive Abdominal KT tape (From initial 4 h to 72 h of menstruation). General physio session will also be given to this group. | Other: KinesioTape<br>* 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)<br>|
| Sham Comparator: ST Group<br>This group will receive Abdominal KT tape (without strech) from initial 4 h to 72 h of menstruation. General physio session will also be given to this group. | Other: Sham Tape<br>* This group will receive KT tapping without stretch on the sacral and suprapubic region.<br>|
| Other: CT Group<br>this group will receive 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. | Other: General Physio session<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | 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. | Changes from Baseline to 8th week | 
| Visual Analog Scale | 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. | Changes from 8th week to 12th week | 
| Menstrual Symptom Questionnaire | 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. | Changes from Baseline to 8th week | 
| Menstrual Symptom Questionnaire | 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. | Changes from 8th week to 12th week | 
| Health-related life quality | 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. | Changes from Baseline to 8th week | 
| Health-related life quality | 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. | Changes from 8th week to 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Structured 20-items Academic Performance questionnaire | 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. | Changes from Baseline to 8th week | 
| Self-Structured 20-items Academic Performance questionnaire | 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. | Changes from 8th week to 12th week |