EpisiotomySSC VAS HPANCT07914517
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
A study testing Skin-to-skin contact during episiotomy repair in people with Episiotomy and Pain, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
Episiotomy is a surgical incision made in the perineum during the second stage of labor. The suturing (repair) process following episiotomy causes significant acute perineal pain and state anxiety in women due to the rich nerve supply of the perineum. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Episiotomy, Pain
- What is being tested?
- Skin-to-skin contact during episiotomy repair
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being able to speak and understand Turkish.
- Being 18-49 years of age.
- Having a spontaneous vaginal birth with mediolateral episiotomy.
- Having no signs of infection, such as redness or swelling, in the episiotomy area.
- Voluntarily agreeing to participate in the study.
Who cannot join
- Conditions requiring more than 5 mL of 2% lidocaine during episiotomy repair.
- Presence of an infectious disease.
- Presence of deep tissue lacerations.
- Vacuum-assisted birth.
- Development of shoulder dystocia.
- Presence of anxiety or an anxiety-related problem.
- Development of postpartum complications, such as uterine atony.
- Presence of a psychiatric disorder that may affect pain or anxiety perception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman Kadın Doğum ve Çocuk Hastalıkları Hastanesi
Adıyaman, Adıyaman Province
Obstetrics and Gynecology Hospital, +90 416 216 10 15, adiyamaneah1@saglik.gov.tr
About this study
Episiotomy is a surgical incision made in the perineum during the second stage of labor. The suturing (repair) process following episiotomy causes significant acute perineal pain and state anxiety in women due to the rich nerve supply of the perineum. Although the physiological and psychological benefits of early skin-to-skin contact (SSC) for mothers and newborns are widely reported in the literature, studies evaluating the effects of SSC on maternal pain and anxiety during episiotomy repair, when surgical stress is intense, are limited.
The aim of this study is to investigate the effects of early skin-to-skin contact during episiotomy repair on women's pain and state anxiety levels and to compare the group receiving SSC with the group receiving standard routine care. The study will be conducted as a randomized controlled experimental study, and the sample size has been calculated using power analysis. The data collection tools will include the Descriptive Information Form, Visual Analog Scale (VAS), and Spielberger State Anxiety Inventory.
SSC applied during repair stimulates endogenous oxytocin release, reduces hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system activity, supports the parasympathetic system, and provides natural analgesic and anxiolytic effects. It also shifts the mother's attention from the pain of the surgical procedure to her baby. Conducted within the framework of woman-centered midwifery care, this study aims to address the gap in the literature regarding the analgesic and anxiolytic effects of SSC during episiotomy repair and to contribute evidence-based knowledge to clinical midwifery practice.
Read the detailed description
This study is a randomized controlled experimental study. Its aim is to determine the effects of skin-to-skin contact during episiotomy repair on mothers' pain and anxiety levels.
The study will be conducted in the Labor and Delivery Unit of Adıyaman Maternity and Children's Hospital. Data will be collected between November 1, 2026, and March 1, 2027. The unit operates on a shift system, with eight midwives working during daytime hours and six midwives providing shift services. The hospital also has 11 obstetricians and six resident physicians. The labor and delivery unit has a capacity of 21 patients and includes 21 labor and delivery rooms. Normal vaginal births are performed in this unit, which also provides postpartum care for mothers and newborns.
The study population consists of women who give birth vaginally and undergo episiotomy in the hospital's Labor and Delivery Unit. An a priori power analysis was performed using G*Power 3.1.9.2. An effect size of 0.58, statistical power of 95%, and a type I error level of 0.05 were accepted. Based on the assumption of a 10-point reduction in the mean anxiety score, the required sample size was calculated as 126 women, with at least 63 women in each group. The effect size was based on the mean anxiety scores and standard deviations reported in the study by Şolt Kırca and Kanza Gül. Eligible women who voluntarily agree to participate will be included in the study and randomly assigned to the skin-to-skin contact group or the control group using simple randomization.
The inclusion criteria are being able to speak and understand Turkish, being 18-49 years of age, having a spontaneous vaginal birth with mediolateral episiotomy, having no signs of infection such as redness or swelling in the episiotomy area, and voluntarily agreeing to participate.
The exclusion criteria are conditions requiring more than 5 mL of 2% lidocaine during episiotomy repair, the presence of an infectious disease, deep tissue lacerations, vacuum-assisted birth, shoulder dystocia, an anxiety or anxiety-related problem, postpartum complications such as uterine atony, and psychiatric disorders that may affect pain or anxiety perception.
Women who meet the eligibility criteria will be listed according to birth order. Randomization will be performed using the Random Integer Generator in the Numbers section of the Random.org website. At the beginning of the study, a draw will determine which group is represented by the numbers 1 and 2. Women will then be randomly assigned to the skin-to-skin contact group or the control group according to the randomization list. Written informed consent will be obtained from women who agree to participate.
Data will be collected using a Descriptive Information Form, an Episiotomy Assessment Form, the Visual Analog Scale (VAS), and the Spielberger State Anxiety Inventory. The Descriptive Information Form will collect sociodemographic information, including age, education level, employment status, social security, income, and participation in childbirth preparation education. The Episiotomy Assessment Form will record characteristics of the episiotomy and repair process. A disposable paper measuring tape measuring 0-100 mm will be used to assess episiotomy dimensions, and a digital stopwatch will be used to measure repair duration, starting with the first suture and ending when the repair is completed.
The VAS will be used to assess pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable. Higher scores indicate greater perceived pain. The Spielberger State Anxiety Inventory will be used to assess state anxiety at a particular time and under specific conditions. It consists of 20 items rated on a four-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher state anxiety levels.
The researcher will administer the personal information form through face-to-face interviews during the latent phase of labor in the hospital's labor and delivery room. Participants will be informed about the study's purpose and procedures, and written informed consent will be obtained before data collection. Immediately after episiotomy repair, characteristics of the episiotomy and suturing process will be recorded using the Episiotomy Assessment Form.
Pain and anxiety assessments will be performed at the following time points:
- The first VAS measurement will be performed immediately before episiotomy repair.
- The second VAS measurement will be performed five minutes after skin-to-skin contact begins, while suturing is still in progress.
- The third VAS measurement and the Spielberger State Anxiety Inventory will be administered 60 minutes after episiotomy repair is completed.
In the skin-to-skin contact group, the intervention will begin after the internal suturing stage of episiotomy repair and continue throughout skin suturing. The newborn will be positioned to maintain direct skin contact with the mother. The safety of the mother and newborn will be monitored, including observation of the newborn's breathing, skin color, and muscle tone. Maternal comfort and appropriate positioning will be ensured. When clinically necessary, routine care and required medical interventions will take priority. Women in the control group will not receive the study-specific intervention, and VAS and anxiety assessments will be conducted at the same time points as in the skin-to-skin contact group.
The independent variable is skin-to-skin contact during episiotomy repair. The dependent variables are pain intensity and state anxiety during and after episiotomy repair. The study hypotheses are that skin-to-skin contact during episiotomy repair reduces women's pain levels and state anxiety levels.
Data will be analyzed using descriptive statistics, the Shapiro-Wilk test, Pearson's chi-square test, Fisher's exact test, the independent-samples t-test, the Mann-Whitney U test, mixed-design repeated-measures analysis of variance, and, where necessary, linear mixed-effects models. Appropriate group and time comparisons will be performed for state anxiety scores. Statistical significance will be set at p < 0.05.
- Conditions
- Episiotomy, Pain
- Being tested
- Skin-to-skin contact during episiotomy repair
- Keywords
- skin-to-skin contact, episiotomy, pain, state anxiety, midwifery care
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skin contact during episiotomy repairBehavioural
Skin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth
| Study group | Role | What they receive |
|---|---|---|
| SKİN-TO-SKİN CONTACT GROUP | Experimental | Skin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth Receives: Behavioral: Skin-to-skin contact during episiotomy repair |
| CONTROL GROUP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Episiotomy Repair
Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (the most severe pain imaginable). Measurements will be performed immediately before episiotomy repair, five minutes after the start of skin-to-skin contact while suturing is ongoing, and 60 minutes after completion of episiotomy repair.
Measured: Immediately before episiotomy repair; 5 minutes after the start of skin-to-skin contact while suturing is ongoing; and 60 minutes after completion of episiotomy repair.
Secondary outcomes (1)
State Anxiety
State anxiety will be assessed using the Spielberger State Anxiety Inventory, which consists of 20 items rated on a four-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety.
Measured: 60 minutes after completion of episiotomy repair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- 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
- Participants will be randomly assigned to one of two parallel groups: a skin-to-skin contact group or a control group receiving standard routine care. Outcomes will be assessed at the specified time points in both groups.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Beyza Türen, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914517
- Sponsor's protocol ID
- ADYU-TTT-2026-01
- Acronym
- SSC VAS HPA
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
- ClinicalTrials.gov ID
- NCT07914517
- Acronym / sponsor ID
- SSC VAS HPA / ADYU-TTT-2026-01
- Conditions
- Episiotomy, Pain
- Keywords
- skin-to-skin contact, episiotomy, pain, state anxiety, midwifery care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Nov 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.
Episiotomy is a surgical incision made in the perineum during the second stage of labor. The suturing (repair) process following episiotomy causes significant acute perineal pain and state anxiety in women due to the rich nerve supply of the perineum. Although the physiological and psychological benefits of early skin-to-skin contact (SSC) for mothers and newborns are widely reported in the literature, studies evaluating the effects of SSC on maternal pain and anxiety during episiotomy repair, when surgical stress is intense, are limited.
The aim of this study is to investigate the effects of early skin-to-skin contact during episiotomy repair on women's pain and state anxiety levels and to compare the group receiving SSC with the group receiving standard routine care. The study will be conducted as a randomized controlled experimental study, and the sample size has been calculated using power analysis. The data collection tools will include the Descriptive Information Form, Visual Analog Scale (VAS), and Spielberger State Anxiety Inventory.
SSC applied during repair stimulates endogenous oxytocin release, reduces hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system activity, supports the parasympathetic system, and provides natural analgesic and anxiolytic effects. It also shifts the mother's attention from the pain of the surgical procedure to her baby. Conducted within the framework of woman-centered midwifery care, this study aims to address the gap in the literature regarding the analgesic and anxiolytic effects of SSC during episiotomy repair and to contribute evidence-based knowledge to clinical midwifery practice.
Detailed description
This study is a randomized controlled experimental study. Its aim is to determine the effects of skin-to-skin contact during episiotomy repair on mothers' pain and anxiety levels.
The study will be conducted in the Labor and Delivery Unit of Adıyaman Maternity and Children's Hospital. Data will be collected between November 1, 2026, and March 1, 2027. The unit operates on a shift system, with eight midwives working during daytime hours and six midwives providing shift services. The hospital also has 11 obstetricians and six resident physicians. The labor and delivery unit has a capacity of 21 patients and includes 21 labor and delivery rooms. Normal vaginal births are performed in this unit, which also provides postpartum care for mothers and newborns.
The study population consists of women who give birth vaginally and undergo episiotomy in the hospital's Labor and Delivery Unit. An a priori power analysis was performed using G*Power 3.1.9.2. An effect size of 0.58, statistical power of 95%, and a type I error level of 0.05 were accepted. Based on the assumption of a 10-point reduction in the mean anxiety score, the required sample size was calculated as 126 women, with at least 63 women in each group. The effect size was based on the mean anxiety scores and standard deviations reported in the study by Şolt Kırca and Kanza Gül. Eligible women who voluntarily agree to participate will be included in the study and randomly assigned to the skin-to-skin contact group or the control group using simple randomization.
The inclusion criteria are being able to speak and understand Turkish, being 18-49 years of age, having a spontaneous vaginal birth with mediolateral episiotomy, having no signs of infection such as redness or swelling in the episiotomy area, and voluntarily agreeing to participate.
The exclusion criteria are conditions requiring more than 5 mL of 2% lidocaine during episiotomy repair, the presence of an infectious disease, deep tissue lacerations, vacuum-assisted birth, shoulder dystocia, an anxiety or anxiety-related problem, postpartum complications such as uterine atony, and psychiatric disorders that may affect pain or anxiety perception.
Women who meet the eligibility criteria will be listed according to birth order. Randomization will be performed using the Random Integer Generator in the Numbers section of the Random.org website. At the beginning of the study, a draw will determine which group is represented by the numbers 1 and 2. Women will then be randomly assigned to the skin-to-skin contact group or the control group according to the randomization list. Written informed consent will be obtained from women who agree to participate.
Data will be collected using a Descriptive Information Form, an Episiotomy Assessment Form, the Visual Analog Scale (VAS), and the Spielberger State Anxiety Inventory. The Descriptive Information Form will collect sociodemographic information, including age, education level, employment status, social security, income, and participation in childbirth preparation education. The Episiotomy Assessment Form will record characteristics of the episiotomy and repair process. A disposable paper measuring tape measuring 0-100 mm will be used to assess episiotomy dimensions, and a digital stopwatch will be used to measure repair duration, starting with the first suture and ending when the repair is completed.
The VAS will be used to assess pain intensity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain imaginable. Higher scores indicate greater perceived pain. The Spielberger State Anxiety Inventory will be used to assess state anxiety at a particular time and under specific conditions. It consists of 20 items rated on a four-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate higher state anxiety levels.
The researcher will administer the personal information form through face-to-face interviews during the latent phase of labor in the hospital's labor and delivery room. Participants will be informed about the study's purpose and procedures, and written informed consent will be obtained before data collection. Immediately after episiotomy repair, characteristics of the episiotomy and suturing process will be recorded using the Episiotomy Assessment Form.
Pain and anxiety assessments will be performed at the following time points:
- The first VAS measurement will be performed immediately before episiotomy repair.
- The second VAS measurement will be performed five minutes after skin-to-skin contact begins, while suturing is still in progress.
- The third VAS measurement and the Spielberger State Anxiety Inventory will be administered 60 minutes after episiotomy repair is completed.
In the skin-to-skin contact group, the intervention will begin after the internal suturing stage of episiotomy repair and continue throughout skin suturing. The newborn will be positioned to maintain direct skin contact with the mother. The safety of the mother and newborn will be monitored, including observation of the newborn's breathing, skin color, and muscle tone. Maternal comfort and appropriate positioning will be ensured. When clinically necessary, routine care and required medical interventions will take priority. Women in the control group will not receive the study-specific intervention, and VAS and anxiety assessments will be conducted at the same time points as in the skin-to-skin contact group.
The independent variable is skin-to-skin contact during episiotomy repair. The dependent variables are pain intensity and state anxiety during and after episiotomy repair. The study hypotheses are that skin-to-skin contact during episiotomy repair reduces women's pain levels and state anxiety levels.
Data will be analyzed using descriptive statistics, the Shapiro-Wilk test, Pearson's chi-square test, Fisher's exact test, the independent-samples t-test, the Mann-Whitney U test, mixed-design repeated-measures analysis of variance, and, where necessary, linear mixed-effects models. Appropriate group and time comparisons will be performed for state anxiety scores. Statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a skin-to-skin contact group or a control group receiving standard routine care. Outcomes will be assessed at the specified time points in both groups.
| Arm | Type | Receives |
|---|---|---|
| SKİN-TO-SKİN CONTACT GROUP | Experimental | Behavioral: Skin-to-skin contact during episiotomy repairSkin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth |
| CONTROL GROUP | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being able to speak and understand Turkish.
- Being 18-49 years of age.
- Having a spontaneous vaginal birth with mediolateral episiotomy.
- Having no signs of infection, such as redness or swelling, in the episiotomy area.
- Voluntarily agreeing to participate in the study.
Key exclusion criteria (8 listed)
- Conditions requiring more than 5 mL of 2% lidocaine during episiotomy repair.
- Presence of an infectious disease.
- Presence of deep tissue lacerations.
- Vacuum-assisted birth.
- Development of shoulder dystocia.
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 contact during episiotomy repairSkin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth | Behavioural | SKİN-TO-SKİN CONTACT GROUP |
Primary outcome
Pain Intensity During Episiotomy Repair
Time frame: Immediately before episiotomy repair; 5 minutes after the start of skin-to-skin contact while suturing is ongoing; and 60 minutes after completion of episiotomy repair.
Pain intensity will be assessed using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (the most severe pain imaginable). Measurements will be performed immediately before episiotomy repair, five minutes after the start of skin-to-skin contact while suturing is ongoing, and 60 minutes after completion of episiotomy repair.
1 secondary outcome
State Anxiety
Time frame: 60 minutes after completion of episiotomy repair.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Episiotomy
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Active, not recruitingObservational study
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Episiotomy Wound
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Not yet recruiting
Pudendal Nerve Block for Pain Relief During Episiotomy Repair
Episiotomy , Perineal Pain
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.
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 during episiotomy repair in people with Episiotomy and Pain, run by Adiyaman 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Beyza Türen, MSc (+90 546 884 75 16, trnelif135@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Episiotomy Repair (time frame: Immediately before episiotomy repair; 5 minutes after the start of skin-to-skin contact while suturing is ongoing; and 60 minutes after completion of episiotomy repair.). 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 5 Nov 2026.