Acute Pain, Anxiety, Breastfeeding, Cortisol, Episiotomy, Midwifery, PAIN, ANXIETY, AND COMFORT, Postpartum Comfort, Postpartum Comfort Scale, Stress Ball, Stress Physiological, Virtual Goggles, Virtual Reality
Conditions
Keywords
Breastfeeding, Virtual Reality, Stress Ball, Midwifery Care, Primiparous Women, Randomized Controlled Trial, Salivary Cortisol, Episiotomy, Episiotomy Repair
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBreastfeeding and Skin-to-Skin Contact
Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
DEVICEVirtual Reality (VR) Goggles
Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
BEHAVIORALRhythmic Stress Ball Application
A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.
Sponsors
Aydin Adnan Menderes University
Aydın Aynan Menderes University Scientific Research Projects Coordination Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Spontaneous vaginal delivery requiring a mediolateral episiotomy. * Newborn birth weight between 2500 and 4500 grams. * Newborn Apgar scores of 7 or higher at the 1st and 5th minutes. * Ability to read, understand, and speak Turkish fluently. * Voluntary participation with signed informed consent. Exclusion and Withdrawal Criteria: * Requesting to withdraw from the research at any stage. * Presence of any congenital anomalies in the newborn. * Presence of maternal visual or hearing impairments. * Occurrence of fetal mortality or morbidity. * Occurrence of anal sphincter injury or 3rd/4th-degree lacerations in addition to the episiotomy. * Performance of the episiotomy repair in an operating room. * Use of assisted delivery methods (e.g., vacuum extraction). * Administration of sedative drugs or extra anesthetic agents (excluding routine local perineal infiltration). * Development of maternal complications (e.g., postpartum hemorrhage) preventing data collection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain (VAS-P) | 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. |
| State-Trait Anxiety Inventory - State (STAI-S) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Levels | 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. |
| Postpartum Comfort Scale | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGizem Fikriye KIRKIZ, Midwife/PhD Candidate
CONTACTAyden ÇOBAN, PhD, Prof.
STUDY_DIRECTORAyden ÇOBAN, PhD, Prof.
AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery
Outcome results
None listed