Clinical trial NCT05909956: Effects of Therapeutic Tapping in Primary Dysmenorrhea
Official title: Effects of Therapeutic Tapping on Clinical Symptoms in Students With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Changes from Baseline to 8th week
measure: Visual Analog Scale
timeFrame: Changes from 8th week to 12th week
measure: Menstrual Symptom Questionnaire
timeFrame: Changes from Baseline to 8th week
measure: Menstrual Symptom Questionnaire
timeFrame: Changes from 8th week to 12th week
measure: Health-related life quality
timeFrame: Changes from Baseline to 8th week
measure: Health-related life quality
timeFrame: Changes from 8th week to 12th week
Secondary outcomes:
measure: Self-Structured 20-items Academic Performance questionnaire
timeFrame: Changes from Baseline to 8th week
measure: Self-Structured 20-items Academic Performance questionnaire
timeFrame: Changes from 8th week to 12th week
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Iman girl hostels
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.