- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471724
Skin-to-Skin Contact, Cheek Contact and Episiotomy Pain Control
COMPARISON OF THE EFFECTS OF SKIN-TO-SKIN CONTACT, CHEEK CONTACT AND ROUTINE CARE ON PAIN CONTROL FOLLOWING EPISIOTOMY REPAIR: A RANDOMISED CONTROLLED TRIAL
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İmbatlı Mah
-
Izmir, İmbatlı Mah, Turkey (Türkiye), 35400
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: AYSUN EKŞİOĞLU, Associate Professor, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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