NCT06811285

Brief Summary

After a cesarean section, postpartum women may experience pain, fatigue, and various negative mood disturbances. These effects pose a significant public health concern by threatening both maternal and infant health. To prevent these public health problems, it is essential to improve maternal health and well-being. This randomized controlled trial aims to conduct a comparative investigation into the effects of kinesiological taping and foot massage on postpartum pain, fatigue, and mood in women who have undergone cesarean delivery. The primary research questions are as follows: Does the application of kinesiological taping to postpartum women after cesarean section influence pain, fatigue, and mood? Does the application of foot massage to postpartum women after cesarean section influence pain, fatigue, and mood? To address these questions, the study will involve postpartum women who meet the inclusion criteria and provide informed consent. Participants will be randomly assigned to three groups: one group will receive kinesiological taping, another will receive foot massage, and the control group will not receive any intervention. In postpartum women, pain levels will be assessed at postoperative hours 8, 9, 33, and 34. Fatigue and mood will be evaluated at postoperative hour 8 (prior to the intervention) and hour 34.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 2, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

January 31, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

PainFatigueMoodPostpartum women

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    In the study, the Visual Analog Scale (VAS) will be utilized to assess pain levels in postpartum women who have undergone a cesarean section. The VAS was developed by Price et al. in 1983 to evaluate subjective pain and has been widely accepted in the global literature as a reliable and easy-to-administer scale. The VAS consists of a 10 cm vertical or horizontal line with two endpoints labeled differently (0 = No pain at all - Completely comfortable, and 10 = Worst imaginable pain).

    Between the 8th and 34th postoperative hours.

Secondary Outcomes (2)

  • Fatigue and energy assessment

    Between the 8th and 34th postoperative hours.

  • Mood assessment (Positive and negative )

    Between the 8th and 34th postoperative hours.

Study Arms (3)

Kinesiological Taping Group

EXPERIMENTAL

The Kinesiological Taping group will receive two parallel I-shaped kinesiological taping applications.

Other: Kinesiological Taping

Foot Massage Group

EXPERIMENTAL

The Foot Massage Group will receive foot massage for 20 minutes.

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

The Kinesiological Taping group will receive two parallel I-shaped kinesiological taping applications.

Kinesiological Taping Group

The Foot Massage Group will receive foot massage for 20 minutes.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between the ages of 18-45,
  • Being able to speak Turkish and to express oneself in Turkish,
  • Having undergone a pregnancy duration of 38-42 weeks,
  • Have given birth via cesarean section,
  • Have undergone a transverse incision,
  • To give live birth, delivered a baby weighing between 2500 and 4000 grams,
  • Having a singleton pregnancy,
  • The analgesics used should be of the same type and administered in the same dose,
  • Not having dermatological issues.
  • No mental disability or perception problems,
  • No communication difficulties,
  • Be willing to participate in the study.

You may not qualify if:

  • Having been diagnosed with allergic skin conditions and developing postpartum complications (such as bleeding, infection, etc.),
  • A body mass index of 40 or higher,
  • Hemoglobin levels lower than 9 g/dL
  • Hematocrit levels lower than 30%,
  • Postpartum women who have experienced a neonatal anomaly,
  • Women who have been diagnosed with any psychiatric disorder,
  • Used different types and doses of analgesics in the postoperative period,
  • Postpartum women whose infants are receiving treatment in the neonatal intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak University

Uşak, Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevser Gursan, Dr

    Uşak University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

December 2, 2024

Primary Completion

April 18, 2025

Study Completion

April 18, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations