NCT06661109

Brief Summary

Brief Summary: This randomized, single-blind study aimed to evaluate the effects of kinesio taping on pain management, comfort, and satisfaction of women after cesarean section. The main question(s) it aimed to answer were:

  • Is there a difference in mean pain scores between the intervention group and the control group as a result of kinesio taping?
  • Is there a difference in mean comfort levels between the intervention group and the control group as a result of kinesio taping?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

October 24, 2024

Last Update Submit

October 25, 2024

Conditions

Keywords

kinesio-tapekinesio-tapingcomfort levelnursenursing

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) is a method used to make some values that cannot be expressed numerically measurable. In this study, VAS will be used to determine the pain levels of women. Evaluation is made on a scale between 0 and 10 cm; 0 cm represents no pain, while 10 cm represents the most severe pain. On the scale, 0-44 mm is classified as mild pain, 45-74 mm as moderate pain, and 75-100 mm as severe pain. This test, which has been used for many years, is a widely accepted assessment tool known in the literature for its reliability and easy applicability.

    At 1 hour after taping and at 24 and 48 hours postoperatively

Secondary Outcomes (1)

  • Perianesthesia Comfort Scale (PCS)

    At 1 hour after taping and at 24 and 48 hours postoperatively

Study Arms (2)

Kinesio Taping

EXPERIMENTAL

Kinesio tape will be applied with 100% tension.

Other: Intervention (Kinesio Taping) group

Sham Taping

PLACEBO COMPARATOR

Kinesio tape will be applied without tension.

Other: Intervention (Kinesio Taping) group

Interventions

No randomized study was found investigating the effect of kinesio taping on comfort levels in women having a cesarean delivery.

Kinesio TapingSham Taping

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who have had a caesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-45
  • Having undergone Caesarean section surgery and transverse incision technique
  • Having undergone spinal or epidural anesthesia
  • Having been classified as I or II by the American Society of Anesthesiologists (ASA)
  • Having no dermatological, mental or perception problems
  • Being open to communication
  • Being willing to participate in the study

You may not qualify if:

  • Having been diagnosed with an allergic skin disease,
  • Developing postpartum complications (bleeding, infection, etc.),
  • Expressing a desire to withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

MethodsPopulation Groups

Intervention Hierarchy (Ancestors)

Investigative TechniquesDemographyPopulation Characteristics

Central Study Contacts

YAĞMUR SÜRMELİ, PhD

CONTACT

ESMA GÖKÇE, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There will be 2 groups (intervention and placebo)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER DR.

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 28, 2024

Study Start

December 2, 2024

Primary Completion

May 31, 2025

Study Completion

August 1, 2025

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share