The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure.
The main questions it aims to answer are:
Does breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth?
Researcher will compare these three intervention groups to a "control group" (mothers receiving standard hospital care) to see which approach is most effective.
Participants will:
Be randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care.
Use their assigned intervention throughout the entire episiotomy repair process.
Provide saliva samples before and after the procedure to measure stress hormones (cortisol).
Rate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished.
Complete a survey about their comfort levels between 6 and 24 hours after the delivery.
Pregnant women between 18 and 45 years of age.
Primiparous women (first-time mothers).
Gestational age between 37 and 42 weeks (term pregnancy).
Singleton pregnancy with a vertex presentation.
None
Parallel
Breastfeeding and Skin-to-Skin Contact
Procedure/SurgeryMidwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
Virtual Reality (VR) Goggles
DeviceUse of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
Rhythmic Stress Ball Application
BehavioralA physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.
Visual Analog Scale for Pain (VAS-P)
The Visual Analog Scale (VAS) will be used to measure the intensity of pain experienced by the mother. The scale consists of a 10-cm horizontal line. Total scores range from 0 to 10. A score of 0 indicates "no pain," and a score of 10 indicates "the worst possible pain." Higher scores indicate a higher level of pain.
State-Trait Anxiety Inventory - State (STAI-S)
The State-Trait Anxiety Inventory (STAI) will be used to measure the mother's current anxiety level. The scale consists of 20 items. Total scores range from 20 to 80. Higher scores indicate a higher level of anxiety.
Salivary Cortisol Levels
Saliva samples will be collected to measure physiological stress. Cortisol levels will be analyzed in a laboratory. A decrease or lower level of cortisol indicates a reduced physiological stress response. Saliva samples will be collected from participants to measure cortisol levels. Samples will be collected using a non-invasive cotton swab (Salivette) method, placed under the tongue for approximately 2 minutes until saturated. The samples will then be stored at -20°C until laboratory analysis.
Postpartum Comfort Scale
The Postpartum Comfort Scale, developed by Karakaplan and Yıldız (2010) based on Kolcaba's Comfort Theory, will be used to assess maternal comfort. The scale consists of 34 items across three domains: physical, psychospiritual, and sociocultural. Scoring: Items are rated on a 5-point Likert scale. Negative items (4, 6, 8, 9, 10, 12, 13, 16, 17, 21, 22, 26, 27, 28, 29, 30, 33, 34) are reverse-coded. Total Score Range: 34 to 170. Average Score: The total score is divided by the number of items (34) to obtain a mean score ranging from 1 to 5. Interpretation: Higher scores indicate a higher level of postpartum comfort (1 = lowest comfort, 5 = highest comfort). The scale has a reported Cronbach's Alpha of 0.78.
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Aydin Adnan Menderes University
Lead sponsor
Aydın Aynan Menderes University Scientific Research Projects Coordination Unit
Collaborator
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