An interventional study of Skin-to-skin contact during episiotomy repair in Episiotomy and Pain, sponsored by Adiyaman University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Adiyaman University · Not applicable, Interventional, and Supportive care
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.
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:
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 126 is above the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria:
Skin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth
Behavioral: Skin-to-skin contact during episiotomy repair
Skin-to-skin contact between the mother and newborn during episiotomy repair following vaginal birth
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.
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.
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.
Time frame: 60 minutes after completion of episiotomy repair.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 4 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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