Nazilli State Hospital
Aydin, Nazilli, 09800, Turkey (Türkiye)
NCT Number: NCT07510477
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
Aydin, Nazilli, 09800, Turkey (Türkiye)
Study Rationale and Background:
Episiotomy is a common surgical procedure performed during vaginal delivery to facilitate the baby's passage. In Turkey, episiotomy rates among primiparous women are reported to be as high as 89-95%. This procedure often leads to significant maternal pain and anxiety during the repair (stitching) phase. There is an increasing need for person-centered interventions that can be easily integrated into midwifery care to manage pain and stress.
Objective:
The primary objective of this randomized controlled experimental study is to evaluate the effects of three different interventions-Breastfeeding, Virtual Reality (VR) Goggles, and Stress Ball-on maternal pain, anxiety, saliva cortisol levels, and postpartum comfort during episiotomy repair.
Methodology and Interventions:
The study will be conducted with primiparous women who are randomly assigned to one of four groups:
Intervention Group 1 (Breastfeeding): Mothers will initiate breastfeeding their newborns during the episiotomy repair.
Intervention Group 2 (Virtual Reality): Mothers will wear VR goggles and watch relaxing, pre-selected content to provide a cognitive distraction during the procedure.
Intervention Group 3 (Stress Ball): Mothers will use a stress ball to redirect their focus and manage physical tension during the repair.
Control Group: Mothers will receive standard hospital care and routine midwifery support.
Measurements and Data Collection:
Data will be collected at multiple time points to assess the physiological and psychological impact of the interventions:
Pain Intensity: Measured using the Visual Analog Scale (VAS-P). Assessments will be performed twice: immediately before the start of the repair and immediately after completion.
Anxiety Levels: Evaluated using the State-Trait Anxiety Inventory (STAI-S). Scores will be recorded before and after the repair process.
Biochemical Stress Response: Saliva cortisol levels will be analyzed to provide an objective measure of the stress response. Samples will be collected pre-intervention and post-intervention.
Postpartum Comfort: Assessed using the Postpartum Comfort Scale between the 6th and 24th hour following the delivery.
Statistical Analysis Plan:
The data will be analyzed to compare the efficacy of the three interventions against the control group. Differences in pain, anxiety, cortisol, and comfort scores will be evaluated to determine which application (if any) significantly affects the maternal experience during the early postpartum period.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion and Withdrawal Criteria:
Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
Other names: Early Breastfeeding, SSC
Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
Other names: VR, Visual Distraction
A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.
Other names: Squeeze Ball
Time frame: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).
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.
Time frame: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).
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.
Time frame: Baseline (before repair) and Post-intervention (immediately after repair).
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.
Time frame: Measured once between 6 and 24 hours after delivery.
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.
Contact information is provided by the study sponsor or research team.
Ayden ÇOBAN, PhD, Prof.
CONTACT
+90 0256 220 30 00 ext. 3030
Gizem Fikriye KIRKIZ, Midwife/PhD Candidate
CONTACT
Aydin Adnan Menderes University
Other
Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair in Primiparous Women: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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