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| ID | Type | Description | Link |
|---|---|---|---|
| Decision No:906 | Other Identifier | Izmir Bakırçay University |
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| Name | Class |
|---|---|
| Izmir Bakircay University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding frequency | Number of breastfeeding episodes during early postpartum period | Within first 12 hours postpartum |
| Newborn APGAR scores | APGAR scores at 1 and 5 minutes after birth |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Aysun Ekşioğlu, Associate Professor | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University | Izmir | İmbatlı Mah | 35400 | Turkey (Türkiye) |
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.
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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.
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| 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. |
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| 1st and 5th minute after birth |