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Completed

NCT Number: NCT07471724

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, İmbatlı Mah, 35400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Breastfeeding frequency

    Time frame: Within first 12 hours postpartum

    Number of breastfeeding episodes during early postpartum period

  2. Newborn APGAR scores

    Time frame: 1st and 5th minute after birth

    APGAR scores at 1 and 5 minutes after birth

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Izmir Bakircay University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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