Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair

Official title

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

Overview

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

• Procedure Breastfeeding and Skin-to-Skin Contact
  Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
• Device Virtual Reality (VR) Goggles
  Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
• Behavioral Rhythmic Stress Ball Application
  A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.

Primary outcome measures

• Visual Analog Scale for Pain (VAS-P) [Time frame: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).]
• State-Trait Anxiety Inventory - State (STAI-S) [Time frame: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).]

Secondary outcome measures (2)

• Salivary Cortisol Levels [Time frame: Baseline (before repair) and Post-intervention (immediately after repair).]
• Postpartum Comfort Scale [Time frame: Measured once between 6 and 24 hours after delivery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Nazilli State Hospital — Aydin

Publications

• 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. PMID 34962008
• 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. PMID 30027283
• Spielberger, C. D., Gorsuch, R. L., & Lushene. R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
• Karakaplan, S., & Yildiz, H. (2010). Development of the Postpartum Comfort Scale. Maltepe University Journal of Nursing Science and Art, 3(1), 55-65.
• 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. PMID 37404226
• 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. PMID 19095358
• 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. PMID 1437591

Identifiers

NCT: NCT07510477 · 2025/2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗