NCT05856097

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 4, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 4, 2023

Last Update Submit

May 11, 2023

Conditions

Keywords

AcheBreathing Exercises

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

kinesio taping with diaphragmatic breathing

EXPERIMENTAL

kinesio taping application with diaphragmatic breathing

Other: kinesio taping with diaphragmatic breathing

kinesio taping without diaphragmatic breathing

ACTIVE COMPARATOR

kinesio taping application without diaphragmatic breathing

Other: kinesio taping without diaphragmatic breathing

Interventions

.kinesio tape was applied on1st day of intervention with the 20 minutes session of diaphragmatic breathing 3 sessions were given

kinesio taping with diaphragmatic breathing

kinesio tape was applied day 1st of intervention. 3 sessions were given

kinesio taping without diaphragmatic breathing

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales are included for the study to record the results after cesarean birth process.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous patients
  • Participants having no serious medical illness

You may not qualify if:

  • Multi gravida patients
  • Any serious morbidity
  • Patient gone through any other abdominal surgery except of cesarean section
  • Patients with the infectious wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District head quarter hospital jhang

Jhang, Punjab Province, 35200, Pakistan

RECRUITING

Related Publications (14)

  • 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/

    PMID: 30398818BACKGROUND
  • 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.

    PMID: 31307417BACKGROUND
  • 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.

    PMID: 34703057BACKGROUND
  • 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
  • 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.

    PMID: 35280198BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30530959BACKGROUND
  • 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.

    PMID: 35929048BACKGROUND
  • Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.

    PMID: 33076360BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33749760BACKGROUND
  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hafiza Mehjabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 4, 2023

First Posted

May 12, 2023

Study Start

May 4, 2023

Primary Completion

September 3, 2023

Study Completion

October 3, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations