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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05856097
Other study ID # REC/RCR&AHS/23/0519
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2023
Est. completion date October 3, 2023

Study information

Verified date May 2023
Source Riphah International University
Contact Imran Amjad, phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cesarean section is a major abdominal surgery and major challenge of it is to manage the pain and make the patient mobile .In spite of the advantageous effects of kinesio taping and diaphragmatic breathing, limited, data reported to study analgesic effects on pain management and mobility restoration in acute phase of cesarean section.. This study will aim to meet the dares which are associated with cesarean section by reducing the incisional pain associated with improvement in physical mobility as a non-pharmacological treatment.


Description:

In year 2022 conducted a study to evaluate the effects of kinesio taping with the breathing exercises on the management of pain after c section .Their title of study was The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. This study was conducted among 132 participants between June 2017 and 18.kinesio taping was applied immediately after the surgery and on the post op day 1, 2, 3 breathing exercises were performed for 30 mins three times a day. Their study concluded that kinesio taping is a reliable method to cover up the acute pain in the gynaecological abdominal surgery. In the year 2022 a study was conducted with the title The effects of kinesio tape on low back pain and disability in pregnant women to scrutinize the effects of kinesio taping on low back pain and disability in pregnant females. It was a single blind clinical trial including 80 pregnant females. Two randomly assigned groups were made of in which pain was assessed by VAS before and after application of kinesio taping on the day 1st,2nd,7th,and 14th. Disability was measured by Roland-Morris disability questionnaire before and after intervention on day 7th and 14th. Their result concludes that kinesio taping have lasting effects on low back pain disability and reduced disability was noticed .In the year 2020 another study was conducted to study the effects of KT on the pain, anxiety, menstrual cramps in the women with primary dysmenorrhea with the comparison with control and sham tape.51 women with the PD were categorized in the three groups KT, sham tape and control group. KT was applied at the sacral and supra pubic region with the ligament technique in KT group and applied on the trochanter major with no technique in the sham tape group. Pain, anxiety level, and menstrual complaints were examined before and after intervention. Their was positive response of the study responding to the decrease in anxiety level menstrual cramps and pain. To the best of researchers knowledge, there is not enough literature present which can justify the efficacy of these interventions in a justified manner. Data is not sufficient that supports combined efficacy of these two interventions after cesarean section regarding pain management and mobility.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date October 3, 2023
Est. primary completion date September 3, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 35 Years
Eligibility Inclusion Criteria: - Primiparous patients - Participants having no serious medical illness Exclusion Criteria: - Multi gravida patients - Any serious morbidity - Patient gone through any other abdominal surgery except of cesarean section - Patients with the infectious wound

Study Design


Related Conditions & MeSH terms


Intervention

Other:
kinesio taping with diaphragmatic breathing
.kinesio tape was applied on1st day of intervention with the 20 minutes session of diaphragmatic breathing 3 sessions were given
kinesio taping without diaphragmatic breathing
kinesio tape was applied day 1st of intervention. 3 sessions were given

Locations

Country Name City State
Pakistan District head quarter hospital jhang Jhang Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (14)

Aalishahi T, Maryam-Lotfipur-Rafsanjani S, Ghorashi Z, Sayadi AR. The Effects of Kinesio Tape on Low Back Pain and Disability in Pregnant Women. Iran J Nurs Midwifery Res. 2022 Jan 25;27(1):41-46. doi: 10.4103/ijnmr.IJNMR_291_20. eCollection 2022 Jan-Feb. — View Citation

Boynton T, Kumpar D, VanGilder C. The bedside mobility assessment tool 2.0. American Nurse Journal. 2020;15(7):15.

Espi-Lopez GV, Ingles M, Ferrando AC, Serra-Ano P. Effect of Kinesio taping on clinical symptoms in people with fibromyalgia: A randomized clinical trial. J Back Musculoskelet Rehabil. 2019;32(4):561-567. doi: 10.3233/BMR-171100. — View Citation

Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065. — View Citation

Kuravskaya YV, Aravitskaya M. EFFECTIVENESS OF RECOVERY OF THE PSYCHO-EMOTIONAL AND PHYSICAL STATUS OF WOMEN WHO HAVE SUFFERED A CAESAREAN SECTION BY MEANS OF PHYSICAL THERAPY. Art of Medicine. 2022:50-5.

Mohamed H, Yousef A, Kamel H-E, Oweda K, Abdelsameaa G. Kinesio Taping and Strength Recovery of Postnatal Abdominal Muscles after Cesarean Section. Egyptian Journal of Physical Therapy. 2020;4(1):13-9.

Nugent SM, Lovejoy TI, Shull S, Dobscha SK, Morasco BJ. Associations of Pain Numeric Rating Scale Scores Collected during Usual Care with Research Administered Patient Reported Pain Outcomes. Pain Med. 2021 Oct 8;22(10):2235-2241. doi: 10.1093/pm/pnab110. — View Citation

Rose A, Carter N, Vann C, Lloyd-Penza M, Andrusko M. Implementing Bedside Mobility Assessment Tool to Improve Patient Outcomes and Staff Communication. Medsurg Nursing. 2022;31(1):32-6.

Shahbazi M, Sarrafzadeh J, Fatemi TS, Hafizi L. Effect of thoracic Kinesio taping on acute lumbar and leg pain in a pregnant woman: A case report. Sports Orthopaedics and Traumatology. 2021.

Singla N, Garg K, Jain R, Malhotra A, Singh MR, Grewal A. Analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in caesarean section: A prospective randomised controlled study. Indian J Anaesth. 2021 Sep;65(Suppl 3):S121-S126. doi: 10.4103/ija.IJA_228_21. Epub 2021 Sep 15. — View 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. — View Citation

Weckesser A, Farmer N, Dam R, Wilson A, Morton VH, Morris RK. Women's perspectives on caesarean section recovery, infection and the PREPS trial: a qualitative pilot study. BMC Pregnancy Childbirth. 2019 Jul 15;19(1):245. doi: 10.1186/s12884-019-2402-8. — View Citation

WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/ — View Citation

Yilmaz S, Terzioglu F. The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. Int J Nurs Pract. 2023 Apr;29(2):e13088. doi: 10.1111/ijn.13088. Epub 2022 Aug 4. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale Changes from baseline A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. 4th week
Primary bedside mobility assessment tool (BMAT) Changes from baseline BMAT is a tool designed for nurses to assess patient mobility in acute care. The BMAT allows nurses (and other healthcare workers) to determine the appropriate patient handling and mobility equipment or device to safely move or mobilize the patient. It consists of four steps, first is sit and shake, second is stretch and point ,third is stand and fourth is step. Mobility level 1,2,3and 4 is given to patients according to their level of mobility. 4th week
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