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Kinesio Taping With and Without Diaphragmatic Breathing in Women After Cesarean Section

Primary Purpose

Cesarean Section Complications

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
kinesio taping with diaphragmatic breathing
kinesio taping without diaphragmatic breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section Complications focused on measuring Ache, Breathing Exercises

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • District head quarter hospital jhangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

kinesio taping with diaphragmatic breathing

kinesio taping without diaphragmatic breathing

Arm Description

kinesio taping application with diaphragmatic breathing

kinesio taping application without diaphragmatic breathing

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2023
Last Updated
May 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05856097
Brief Title
Kinesio Taping With and Without Diaphragmatic Breathing in Women After Cesarean Section
Official Title
Effects of Kinesio Taping With and Without Diaphragmatic Breathing on Incisional Pain and Mobility in Women After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
September 3, 2023 (Anticipated)
Study Completion Date
October 3, 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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Ache, Breathing Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesio taping with diaphragmatic breathing
Arm Type
Experimental
Arm Description
kinesio taping application with diaphragmatic breathing
Arm Title
kinesio taping without diaphragmatic breathing
Arm Type
Active Comparator
Arm Description
kinesio taping application without diaphragmatic breathing
Intervention Type
Other
Intervention Name(s)
kinesio taping with diaphragmatic breathing
Intervention Description
.kinesio tape was applied on1st day of intervention with the 20 minutes session of diaphragmatic breathing 3 sessions were given
Intervention Type
Other
Intervention Name(s)
kinesio taping without diaphragmatic breathing
Intervention Description
kinesio tape was applied day 1st of intervention. 3 sessions were given
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
4th week
Title
bedside mobility assessment tool (BMAT)
Description
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.
Time Frame
4th week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females are included for the study to record the results after cesarean birth process.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District head quarter hospital jhang
City
Jhang
State/Province
Punjab
ZIP/Postal Code
35200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen
Phone
03026577666
Email
hafiza.mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Farwa Batool, MS-WHPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30398818
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/
Results Reference
background
PubMed Identifier
31307417
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.
Results Reference
background
PubMed Identifier
34703057
Citation
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.
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
PubMed Identifier
35280198
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
30530959
Citation
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.
Results Reference
background
PubMed Identifier
35929048
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. Erratum In: Int J Nurs Pract. 2023 Aug;29(4):e13166.
Results Reference
background
PubMed Identifier
33076360
Citation
Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.
Results Reference
background
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
33749760
Citation
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.
Results Reference
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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.
Results Reference
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Citation
Boynton T, Kumpar D, VanGilder C. The bedside mobility assessment tool 2.0. American Nurse Journal. 2020;15(7):15.
Results Reference
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Kinesio Taping With and Without Diaphragmatic Breathing in Women After Cesarean Section

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