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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding | Experimental | The breastfeeding intervention is designed to align with "Baby-Friendly Hospital" criteria by initiating breastfeeding within the first 30 to 60 minutes after delivery. The breastfeeding intervention follows a structured protocol where, after initial newborn care, a midwife provides professional support to initiate breastfeeding. The episiotomy repair begins only after successful breastfeeding is established and continues throughout the entire surgical process, ensuring that if the newborn's sucking reflex pauses, skin-to-skin contact is maintained until the repair is completed and the infant's natural sucking reflex has concluded, thereby aiming to evaluate the effects of early breastfeeding and SSC on all clinical and biochemical study outcomes. |
|
| Virtual Reality (VR) | Experimental | This intervention uses VR goggles to provide a sensory distraction during episiotomy repair. The VR intervention is conducted following a hygiene protocol where lenses are cleaned with single-use aseptic wipes, and participants are provided with a selection of relaxing content such as nature videos or calming imagery to watch during the procedure, with the video playback starting after visual checks are performed and the goggles are fitted, continuing throughout the entire stitching process until the episiotomy repair is completed, in order to evaluate its effects on all clinical and biochemical study outcomes. |
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| Stress Ball | Experimental | This intervention uses a rhythmic squeezing technique to provide a physical distraction during episiotomy repair. To maintain a positive environment, the device is referred to as a "squeeze ball" rather than a "stress ball." The stress ball intervention follows a structured hygiene and training protocol where the balls are washed after each use and disinfected with single-use aseptic wipes, while participants are taught a rhythmic technique of counting to three and squeezing the ball once to focus their attention on the physical action; this rhythmic exercise begins before the episiotomy repair starts and continues throughout the entire stitching process until the repair is finished, in order to evaluate its effects on all clinical and biochemical study outcomes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breastfeeding and Skin-to-Skin Contact | Procedure | Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair). |
| 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. | Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion and Withdrawal Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gizem Fikriye KIRKIZ, Midwife/PhD Candidate | Contact | +90 5350343162 | gfkirkiz@gmail.com | |
| Ayden ÇOBAN, PhD, Prof. | Contact | +90 0256 220 30 00 | 3030 | ayden.coban@adu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Ayden ÇOBAN, PhD, Prof. | AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nazilli State Hospital | Aydin | Nazilli | 09800 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34962008 | Background | Zou Y, Li Y, Jiang M, Liu X. Effect of early skin-to-skin contact after vaginal delivery on pain during perineal wound suturing: A randomized controlled trial. J Obstet Gynaecol Res. 2022 Mar;48(3):729-738. doi: 10.1111/jog.15120. Epub 2021 Dec 27. | |
| 30027283 | Background | Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783. |
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ndividual participant data will not be shared to ensure the privacy and confidentiality of the participants, in accordance with the informed consent and the approval of the local ethics committee. Data will only be accessible to the primary investigators for the purpose of the study's analysis.
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| Control Group | No Intervention | Following birth, initial skin-to-skin contact is provided according to hospital routine. The newborn is then placed under a radiant warmer for clinical care and clothing. Standard obstetric and midwifery protocols are followed during the episiotomy repair. Clinical and biochemical outcomes, including pain, anxiety, salivary cortisol levels, and postpartum comfort, are measured at the same intervals as the intervention groups. |
|
| Virtual Reality (VR) Goggles | Device | Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair. |
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| Rhythmic Stress Ball Application | Behavioral | A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure. |
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| Baseline (before repair) and Post-intervention (immediately after repair). |
| 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. | Measured once between 6 and 24 hours after delivery. |
| Background | Spielberger, C. D., Gorsuch, R. L., & Lushene. R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press. |
| Background | Karakaplan, S., & Yildiz, H. (2010). Development of the Postpartum Comfort Scale. Maltepe University Journal of Nursing Science and Art, 3(1), 55-65. |
| 37404226 | Background | Orhan M, Bulez A. The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study. J Pain Res. 2023 Jun 29;16:2227-2239. doi: 10.2147/JPR.S412883. eCollection 2023. |
| 19095358 | Background | Hellhammer DH, Wust S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18. |
| 1437591 | Background | Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available. |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| D005135 | Eye Protective Devices |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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