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

NCT07471724 | Completed

• 2 other identifiers: EGE-SKINTOSKIN-2024Decision No:906
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Pain; Episiotomy Pain; Postpartum Care

Keywords

Kangaroo care; skin to skin contact; Cheek Contact; Vaginal Birth; Postpartum Pain Management; Episiotomy

Outcome Measures

Primary Outcomes (1)

• Episiotomy pain intensity (Numeric Rating Scale)

  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 Outcomes (2)

• Breastfeeding frequency

  Within first 12 hours postpartum

• Newborn APGAR scores

  1st and 5th minute after birth

Study Arms (3)

Skin-to-Skin Contact

EXPERIMENTAL

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.

Behavioral: Skin-to-Skin Contact; Behavioral: Cheek-to-Cheek Contact

Cheek-to-Cheek Contact

EXPERIMENTAL

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.

Behavioral: Skin-to-Skin Contact; Behavioral: Cheek-to-Cheek Contact

Standart care group

OTHER

Participants in this group received routine postpartum care according to hospital protocols, without additional skin-to-skin or cheek-to-cheek contact interventions.

Behavioral: Skin-to-Skin Contact; Behavioral: Cheek-to-Cheek Contact

Interventions

Skin-to-Skin Contact BEHAVIORAL

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.

Cheek-to-Cheek Contact; Skin-to-Skin Contact; Standart care group

Cheek-to-Cheek Contact BEHAVIORAL

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.

Cheek-to-Cheek Contact; Skin-to-Skin Contact; Standart care group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• Izmir Bakircay University: collaborator

Study Sites (1)

Ege University

Izmir, İmbatlı Mah, 35400, Turkey (Türkiye)

Location

Study Officials

• Aysun Ekşioğlu, Associate Professor

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study was designed as a three-arm, parallel-group randomized controlled trial. Eligible participants were randomly assigned during active labour to receive kangaroo care, cheek-to-cheek contact, or standard postpartum care. Outcomes were assessed after episiotomy repair and during the early postpartum period.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 1, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 25, 2024
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

TU (1)