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Clinical Trials/NCT05909956
NCT05909956CompletedNot Applicable

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

Riphah International University1 site in 1 country67 target enrollmentStarted: June 7, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
1
Primary Endpoint
Visual Analog Scale

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

KT Group

Experimental

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.

Intervention: KinesioTape (Other)

ST Group

Sham Comparator

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.

Intervention: Sham Tape (Other)

CT Group

Other

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.

Intervention: General Physio session (Other)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

  • Self-Structured 20-items Academic Performance questionnaire(Changes from 8th week to 12th week)
  • Self-Structured 20-items Academic Performance questionnaire(Changes from Baseline to 8th week)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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