NCT06761755

Brief Summary

The study is randomized controlled trial,The study conducted in two groups. Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation and Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days. The total treatment duration will be 6 weeks. The rationale of this study is to provide empirical evidence regarding the efficacy and safety of kinesiology taping and progressive muscle relaxation. By investigating the potential benefits of this intervention, healthcare professionals can make informed decisions about incorporating K-taping and PMR in primary dysmenorhea. Focusing on the impact of kinesiology taping and progressive muscle relaxation on pain,anxiety, and body awareness aligns with a patient-centered approach to care. The goal is not only to reduce symptoms but also to enhance overall well-being and functional capacity

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Keywords

: Anxiety, dysmenorrhea, pain,

Outcome Measures

Primary Outcomes (3)

  • numerical pain rating scale

    changes from base line NPRS is used to access the pain at 1st day or before the start of menstruation at the end score is calculated by dividing the obtained score by total 0 means no pain and 10 is maximum

    1st day

  • STAI tool (state triate anxiety inventory)

    changes in the baseline ,STAI tool to access the anxiety of the patient feels at the start of menstruation at the end the score is calculated by dividing the score by total 0 means no anxiety and 4 means maximum anxiety

    1st day

  • Body awareness questionaire

    Changes in the baseline, Body Awareness Questionnaire (Shields, Mallory \& Simon, 1989) acess the body awarenss during dysmenorhea , at the end the score is calcuted 0 means not true of me and 7 is the maximum true of me

    1st day

Secondary Outcomes (1)

  • Wallid questionaire

    1st day

Study Arms (2)

Group A

ACTIVE COMPARATOR

Hot pack+ kinesiology taping + progressive muscle relaxation technique Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation

Other: hot pack , K taping , Progressive muscle relaxation

Group B

EXPERIMENTAL

hot pack + kinesiology taping Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days

Other: hot pack , K taping , Progressive muscle relaxation

Interventions

Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days

Group AGroup B

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales with primary dysmenorrhea
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18-25 years
  • Unmarried female
  • Taking ≥4 points from Visual Analog Scale during menstrual cycle
  • Had moderate menstrual pain as measured by WaLLID score

You may not qualify if:

  • Complaints of low back pain due to any other pathology, any skin infection, sensitive skin or allergic to Kinesio Tape.
  • PCOD, Uterine/ ovarian tumor, Acute/ chronic pelvic pathology like PID, endometriosis, spinal pathology and deformity
  • Endometrial polyp, having a pelvic infection, using an intrauterine device, having venous congestion in the internal genital organs.
  • Who take analgesic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (23)

  • Pazare S, Sawant L, Ingale S. The Effects of Kinesio Taping and Isometric Exercises on Pain in Primary Dysmenorrhea-A Comparative Study. Website: www ijpot com. 2019;13(4):4117

    BACKGROUND
  • Bandara EMIA, Kularathne WNI, Brain K, Weerasekara I. Safety and efficacy of therapeutic taping in primary dysmenorrhea: a systematic review and meta-analysis. Sci Rep. 2022 May 3;12(1):7146. doi: 10.1038/s41598-022-11034-w.

    PMID: 35504906BACKGROUND
  • 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: 32379659BACKGROUND
  • 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: 34442453BACKGROUND
  • Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.

    PMID: 33030880BACKGROUND
  • 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: 32379680BACKGROUND
  • Hamdy Nasr Abdelhalim E, Yehia Moustafa Sweelam M, Abd Elaziem Mohamed A, Gomaa Mohamed Amer F, El-Shabory ME-S, El-Hoda N. Effect of Progressive Muscle Relaxation Technique on Pain Intensity and FatigueAssociated with Primary Dysmenorrhea among Female Adolescents. Egyptian Journal of Health Care. 2023;14(1):486-500

    BACKGROUND
  • Guruprasad P, Sharma U, Palekar T, Pimpri P. Immediate Effect of Yoga Postures v/s Physiotherapy Exercises Along with K-Taping on Pain in Dysmenorrhea. International Journal of Scientific Research in Science and Technology. 2019;6(2):487-94.

    BACKGROUND
  • Unal A, Altug F, Erden A, Cavlak U, Senol H. Validity and reliability of the Body Awareness Questionnaire in patients with non-specific chronic low back pain. Acta Neurol Belg. 2021 Jun;121(3):701-705. doi: 10.1007/s13760-020-01399-y. Epub 2020 Jun 21.

    PMID: 32566989BACKGROUND
  • Patel R, Patel AK, Gupta K. Premenstrual symptoms and general health among young adolescent girls: A correlational study. Perspectives on Coping Strategies for Menstrual and Premenstrual Distress: IGI Global; 2023. p. 1-12.

    BACKGROUND
  • Sakpal S, Patil C. Efficacy of Chair Aerobics and Progressive Muscle Relaxation in Primary Dysmenorrhea. Journal of Coastal Life Medicine. 2023;11:1511-6.

    BACKGROUND
  • George SA, Suresh G, Fathima P, Alias H. Effectiveness of physical activity and relaxation techniques in primary dysmenorrhea among college students. Int J Sci Res. 2019;8(11):531-3.

    BACKGROUND
  • Kaur A, Ray G, Mitra M. Comparing the effectiveness of connective tissue mobilisation and kinesio-taping on females with primary dysmenorrhea. Indian Journal of Physiotherapy & Occupational Therapy. 2017;11:70-5

    BACKGROUND
  • Temizkan S, BUDAK M. The Effects of Kinesiological Taping and Aerobic Exercise in Women with Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial. 2021.

    BACKGROUND
  • Yildiz E, Acaroglu R. The Effect of Massage and Progressive Relaxation Exercises on Pain Intensity and Menstrual Symptoms in Students With Primary Dysmenorrhea: A Randomized Controlled Trial. Holist Nurs Pract. 2022 Sep-Oct 01;36(5):284-294. doi: 10.1097/HNP.0000000000000541.

    PMID: 35981113BACKGROUND
  • Jiang J, Zhuang Y, Si S, Cheng H, Alifu X, Mo M, Zhou H, Liu H, Yu Y. The Association of Reproductive Hormones During the Menstrual Period with Primary Dysmenorrhea. Int J Womens Health. 2023 Oct 9;15:1501-1514. doi: 10.2147/IJWH.S421950. eCollection 2023.

    PMID: 37840555BACKGROUND
  • Ibrahim ZM, Alharkan BS, Alanzi EH, Alnasban HA, Alsuwailem MM, Al Khalil WK. Efficacy of active stretching exercises against symptoms of primary dysmenorrhoea in young adult females: a randomized controlled trial. Physiotherapy Quarterly. 2023;31(3).

    BACKGROUND
  • Kirca N, Celik AS. The effect of yoga on pain level in primary dysmenorrhea. Health Care Women Int. 2023 May;44(5):601-620. doi: 10.1080/07399332.2021.1958818. Epub 2021 Sep 17.

    PMID: 34534030BACKGROUND
  • Aldinda TW, Sumarni S, Mulyantoro DK, Azam M. Progressive muscle relaxation application (PURE App) for dysmenorrhea. 2022.

    BACKGROUND
  • Kustriyanti D, Boediarsih B. Muscle Relaxation Therapy for Dysmenorrhea. Health Notions. 2017;1(4):315-20

    BACKGROUND
  • Celik AS, Apay SE. Effect of progressive relaxation exercises on primary dysmenorrhea in Turkish students: A randomized prospective controlled trial. Complement Ther Clin Pract. 2021 Feb;42:101280. doi: 10.1016/j.ctcp.2020.101280. Epub 2020 Nov 30.

    PMID: 33310052BACKGROUND
  • Arshad S, Qureshi MF, Deeba F, Sarshad S, Shiraz S, Farooq S, et al. To compare the effectiveness of taping technique and hydrotherapy in treatment of primary dysmenorrhea. Inter J Endor Health Sci Res. 2018;6(3):34-42.

    BACKGROUND
  • Kumar S, Kanti V, Potturi G, Kumar P. Effect of Kinesio tape application on quality of life and functional independence among Nulligravida women with Primary dysmenorrhea: A randomized control trial. Journal of Disability Studies. 2023;9(1):13-6

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDysmenorrheaPain

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Mental DisordersMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Iqra Abdul ghafoor, PPDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

imran NA amjad, PhD

CONTACT

Iqra Abdul ghafoor, PPDPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

December 23, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations