Skin-to-Skin Contact, Cheek Contact and Episiotomy Pain Control

March 10, 2026 updated by: AYSUN EKŞİOĞLU, Ege University

COMPARISON OF THE EFFECTS OF SKIN-TO-SKIN CONTACT, CHEEK CONTACT AND ROUTINE CARE ON PAIN CONTROL FOLLOWING EPISIOTOMY REPAIR: A RANDOMISED CONTROLLED TRIAL

This randomized controlled trial aimed to evaluate the effects of skin-to-skin contact and kangaroo care on pain control during and after episiotomy repair following vaginal birth. The study was conducted at Izmir Bakircay University Cigli Regional Training and Research Hospital and included 155 healthy women who had spontaneous vaginal birth and healthy newborns. Participants were randomly assigned to three groups: kangaroo care (n=50), cheek-to-cheek contact (n=50), and standard postpartum care (n=55). Pain levels were assessed after episiotomy repair and at the 6th and 12th hours postpartum using the Verbal Rating Scale. Secondary outcomes included breastfeeding frequency and maternal satisfaction. The results indicate that kangaroo care and cheek-to-cheek contact may reduce postpartum episiotomy pain and improve breastfeeding outcomes, supporting their integration into routine maternity care.

Study Overview

Detailed Description

This randomized controlled experimental study was conducted at Izmir Bakircay University Cigli Regional Training and Research Hospital in Türkiye. A total of 155 healthy women who had spontaneous vaginal birth at term (≥37 weeks) and their healthy newborns were included. Eligible participants were aged 18 years and older, had no medical complications, and had newborns with Apgar scores ≥7 at 1 and 5 minutes. Participants were recruited during active labour and randomly assigned to three groups: kangaroo care group (skin-to-skin contact, n=50), cheek-to-cheek contact group (n=50), and control group receiving standard postpartum care (n=55). Randomization was performed using a computer-generated random number sequence, with allocation concealed in sealed, opaque envelopes. The kangaroo care group received immediate skin-to-skin contact between mother and newborn. The cheek-to-cheek contact group received structured cheek-to-cheek contact. The control group received routine postpartum care according to hospital protocols. Primary outcomes included pain levels assessed after episiotomy repair and at the 6th and 12th hours postpartum using the Verbal Rating Scale. Secondary outcomes included breastfeeding frequency, amount of local anesthesia used, and maternal satisfaction. Data were collected using structured questionnaires on sociodemographic and obstetric characteristics. Statistical analyses were performed using descriptive statistics, chi-square tests, one-way ANOVA, and Bonferroni post-hoc tests. All participants provided written informed consent prior to participation. The study was approved by the Izmir Bakircay University Non-Interventional Clinical Research Ethics Committee and conducted in accordance with the Declaration of Helsinki.

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • İmbatlı Mah
      • Izmir, İmbatlı Mah, Turkey (Türkiye), 35400
        • Ege University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 18 years or older

Able to speak and understand Turkish

Singleton pregnancy at ≥37 gestational weeks

Spontaneous vaginal birth with mediolateral episiotomy

Mother and newborn clinically stable after birth

Newborn APGAR score ≥7 at 1 and 5 minutes

Willingness to participate and provision of informed consent

Exclusion Criteria:

  • Operative vaginal birth (vacuum or forceps)

Third- or fourth-degree perineal tear or extensive perineal laceration

Epidural analgesia during labor

Maternal or neonatal complications requiring medical intervention

Conditions requiring maternal-infant separation after birth

Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin-to-Skin Contact
Participants in this group received immediate skin-to-skin contact between the mother and newborn following vaginal birth. The newborn was placed prone on the mother's bare chest during and after episiotomy repair and maintained according to the study protocol.
Immediately after vaginal birth and during episiotomy repair, the newborn was placed prone on the mother's bare chest to provide continuous skin-to-skin contact. The infant was positioned in an upright and safe posture and covered with a blanket when necessary. The intervention was maintained according to the study protocol and supervised by trained midwives.
During and after episiotomy repair, structured cheek-to-cheek contact was established between the mother and the newborn. The infant's cheek was gently placed in contact with the mother's cheek in a comfortable position. The procedure was applied according to standardized instructions and supervised by trained staff.
Experimental: Cheek-to-Cheek Contact
Participants in this group received structured cheek-to-cheek contact between the mother and newborn during and after episiotomy repair. The intervention was applied according to standardized procedures defined in the study protocol.
Immediately after vaginal birth and during episiotomy repair, the newborn was placed prone on the mother's bare chest to provide continuous skin-to-skin contact. The infant was positioned in an upright and safe posture and covered with a blanket when necessary. The intervention was maintained according to the study protocol and supervised by trained midwives.
During and after episiotomy repair, structured cheek-to-cheek contact was established between the mother and the newborn. The infant's cheek was gently placed in contact with the mother's cheek in a comfortable position. The procedure was applied according to standardized instructions and supervised by trained staff.
Other: Standart care group
Participants in this group received routine postpartum care according to hospital protocols, without additional skin-to-skin or cheek-to-cheek contact interventions.
Immediately after vaginal birth and during episiotomy repair, the newborn was placed prone on the mother's bare chest to provide continuous skin-to-skin contact. The infant was positioned in an upright and safe posture and covered with a blanket when necessary. The intervention was maintained according to the study protocol and supervised by trained midwives.
During and after episiotomy repair, structured cheek-to-cheek contact was established between the mother and the newborn. The infant's cheek was gently placed in contact with the mother's cheek in a comfortable position. The procedure was applied according to standardized instructions and supervised by trained staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episiotomy pain intensity (Numeric Rating Scale)
Time Frame: Immediately after episiotomy repair, at 6 hours postpartum, and at 12 hours postpartum
Maternal pain intensity related to episiotomy repair measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Pain scores were self-reported by mothers during follow-up assessments.
Immediately after episiotomy repair, at 6 hours postpartum, and at 12 hours postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding frequency
Time Frame: Within first 12 hours postpartum
Number of breastfeeding episodes during early postpartum period
Within first 12 hours postpartum
Newborn APGAR scores
Time Frame: 1st and 5th minute after birth
APGAR scores at 1 and 5 minutes after birth
1st and 5th minute after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: AYSUN EKŞİOĞLU, Associate Professor, Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

November 25, 2024

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EGE-SKINTOSKIN-2024
  • Decision No:906 (Other Identifier: Izmir Bakırçay University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet made a final decision regarding sharing individual participant data (IPD). Data sharing may be considered in the future upon reasonable request, following institutional policies, ethical approval conditions, and protection of participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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