Postpartum PainNCT07471724
Skin-to-Skin Contact, Cheek Contact and Episiotomy Pain Control
A study testing Skin-to-Skin Contact and Cheek-to-Cheek Contact in people with Postpartum Pain and Episiotomy Pain, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Pain, Episiotomy Pain, Postpartum Care
- What is being tested?
- Skin-to-Skin Contact and Cheek-to-Cheek Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Postpartum Pain, Episiotomy Pain, Postpartum Care
- Being tested
- Skin-to-Skin Contact, Cheek-to-Cheek Contact
- Keywords
- Kangaroo care, skin to skin contact, Cheek Contact, Vaginal Birth, Postpartum Pain Management, Episiotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-Skin ContactBehavioural
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 ContactBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Skin-to-Skin Contact; Behavioral: Cheek-to-Cheek Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after episiotomy repair, at 6 hours postpartum, and at 12 hours postpartum
Secondary outcomes (2)
Breastfeeding frequency
Number of breastfeeding episodes during early postpartum period
Measured: Within first 12 hours postpartum
Newborn APGAR scores
APGAR scores at 1 and 5 minutes after birth
Measured: 1st and 5th minute after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2024
- Primary completion20 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PainStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Bakircay University
- Responsible party
- Principal investigator, AYSUN EKŞİOĞLU, Ege University
- Investigators
- Aysun Ekşioğlu, Associate Professor, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471724
- Sponsor's protocol ID
- EGE-SKINTOSKIN-2024
- Other IDs
- Decision No:906
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07471724
- Acronym / sponsor ID
- EGE-SKINTOSKIN-2024
- Conditions
- Postpartum Pain, Episiotomy Pain, Postpartum Care
- Keywords
- Kangaroo care, skin to skin contact, Cheek Contact, Vaginal Birth, Postpartum Pain Management, Episiotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Izmir Bakircay University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Skin-to-Skin Contact | Experimental | Behavioral: Skin-to-Skin Contact, Behavioral: Cheek-to-Cheek ContactParticipants 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. |
| Cheek-to-Cheek Contact | Experimental | Behavioral: Skin-to-Skin Contact, Behavioral: Cheek-to-Cheek ContactParticipants 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. |
| Standart care group | Other | Behavioral: Skin-to-Skin Contact, Behavioral: Cheek-to-Cheek ContactParticipants in this group received routine postpartum care according to hospital protocols, without additional skin-to-skin or cheek-to-cheek contact interventions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin-to-Skin ContactImmediately 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. | Behavioural | Cheek-to-Cheek Contact, Skin-to-Skin Contact, Standart care group |
| Cheek-to-Cheek ContactDuring 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. | Behavioural | Cheek-to-Cheek Contact, Skin-to-Skin Contact, Standart care group |
Primary outcome
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.
2 secondary outcomes
Breastfeeding frequency
Time frame: Within first 12 hours postpartum
Newborn APGAR scores
Time frame: 1st and 5th minute after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysun Ekşioğlu, Associate Professor principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin-to-Skin Contact and Cheek-to-Cheek Contact in people with Postpartum Pain and Episiotomy Pain, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy pain intensity (Numeric Rating Scale) (time frame: Immediately after episiotomy repair, at 6 hours postpartum, and at 12 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.