Effects of Therapeutic Tapping in Primary Dysmenorrhea

NCT05909956 | Completed

• 1 other identifier: RiphahIU Sidra Malik
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Self-Structured 20-items Academic Performance questionnaire

  Changes from Baseline to 8th week

• Self-Structured 20-items Academic Performance questionnaire

  Changes from 8th week to 12th week

Study Arms (3)

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.

Other: KinesioTape

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.

Other: Sham Tape

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.

Other: General Physio session

Interventions

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)

KT Group

Sham Tape OTHER

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

ST Group

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.

CT Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Iman girl hostels

Islamabad, 46000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 32379659 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34442453 BACKGROUND

• 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.

  PMID: 32379680 BACKGROUND

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 18, 2023
• Study Start: June 7, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)