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Effects of Therapeutic Tapping in Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
KinesioTape
Sham Tape
General Physio session
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Iman girl hostelsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

KT Group

ST Group

CT Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 11, 2023
Last Updated
July 12, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05909956
Brief Title
Effects of Therapeutic Tapping in Primary Dysmenorrhea
Official Title
Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
ST Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
CT Group
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
KinesioTape
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Sham Tape
Intervention Description
This group will receive KT tapping without stretch on the sacral and suprapubic region.
Intervention Type
Other
Intervention Name(s)
General Physio session
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Changes from Baseline to 8th week
Title
Visual Analog Scale
Description
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.
Time Frame
Changes from 8th week to 12th week
Title
Menstrual Symptom Questionnaire
Description
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.
Time Frame
Changes from Baseline to 8th week
Title
Menstrual Symptom Questionnaire
Description
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.
Time Frame
Changes from 8th week to 12th week
Title
Health-related life quality
Description
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.
Time Frame
Changes from Baseline to 8th week
Title
Health-related life quality
Description
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.
Time Frame
Changes from 8th week to 12th week
Secondary Outcome Measure Information:
Title
Self-Structured 20-items Academic Performance questionnaire
Description
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.
Time Frame
Changes from Baseline to 8th week
Title
Self-Structured 20-items Academic Performance questionnaire
Description
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.
Time Frame
Changes from 8th week to 12th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sidra Malik, MS-WHPT*
Phone
0336-0881617
Email
sidramalik883@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iman girl hostels
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Malik, MS.WHPT*
Phone
92 336 0881617
Email
sidramalik883@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32379659
Citation
Dogan H, Eroglu S, Akbayrak T. The effect of kinesio taping and lifestyle changes on pain, body awareness and quality of life in primary dysmenorrhea. Complement Ther Clin Pract. 2020 May;39:101120. doi: 10.1016/j.ctcp.2020.101120. Epub 2020 Feb 22.
Results Reference
background
Citation
Raju J, Suguna M. A study to assess the effect of menstrual symptoms on academic performance among nursing students at selected colleges in Tamil Nadu, India. Int J Appl Res. 2017;3(3):78-80.
Results Reference
background
PubMed Identifier
34442453
Citation
Mejias-Gil E, Garrido-Ardila EM, Montanero-Fernandez J, Jimenez-Palomares M, Rodriguez-Mansilla J, Gonzalez Lopez-Arza MV. Kinesio Taping vs. Auricular Acupressure for the Personalised Treatment of Primary Dysmenorrhoea: A Pilot Randomized Controlled Trial. J Pers Med. 2021 Aug 19;11(8):809. doi: 10.3390/jpm11080809.
Results Reference
background
PubMed Identifier
32379680
Citation
Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
Results Reference
background

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Effects of Therapeutic Tapping in Primary Dysmenorrhea

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