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临床试验/NCT07471724
NCT07471724
已完成
不适用

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

Ege University1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2024年4月1日最近更新:

概览

阶段
不适用
状态
已完成
入组人数
155
试验地点
1
主要终点
Episiotomy pain intensity (Numeric Rating Scale)

概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Skin-to-Skin Contact (Behavioral)

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.

干预措施: Cheek-to-Cheek Contact (Behavioral)

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.

干预措施: Skin-to-Skin Contact (Behavioral)

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.

干预措施: Cheek-to-Cheek Contact (Behavioral)

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.

干预措施: Skin-to-Skin Contact (Behavioral)

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.

干预措施: Cheek-to-Cheek Contact (Behavioral)

结局指标

主要结局

Episiotomy pain intensity (Numeric Rating Scale)

时间窗: 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.

次要结局

  • Breastfeeding frequency(Within first 12 hours postpartum)
  • Newborn APGAR scores(1st and 5th minute after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AYSUN EKŞİOĞLU

Associate Professor

Ege University

研究点 (1)

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