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

March 30, 2026 updated by: Gizem Fikriye Kırkız, Aydin Adnan Menderes University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gizem Fikriye KIRKIZ, Midwife/PhD Candidate
  • Phone Number: +90 5350343162
  • Email: gfkirkiz@gmail.com

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Nazilli
      • Aydin, Nazilli, Turkey (Türkiye), 09800
        • Nazilli State Hospital
        • Contact:
          • Gizem Fikriye Kırkız, Midwife/PhD Candidate
          • Phone Number: 05350343162
          • Email: gfkirkiz@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breastfeeding
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.
Procedure: Breastfeeding and Skin-to-Skin Contact
Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
Other Names:
  • SSC
  • Early Breastfeeding
Experimental: Virtual Reality (VR)
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.
Device: Virtual Reality (VR) Goggles
Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
Other Names:
  • VR
  • Visual Distraction
Experimental: Stress Ball
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.
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.
Other Names:
  • Squeeze Ball
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for Pain (VAS-P)
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.
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).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Cortisol Levels
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.
Baseline (before repair) and Post-intervention (immediately after repair).
Postpartum Comfort Scale
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.
Measured once between 6 and 24 hours after delivery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Collaborators

Aydın Aynan Menderes University Scientific Research Projects Coordination Unit

Investigators

  • Study Director: Ayden ÇOBAN, PhD, Prof., AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/2 (Other Identifier: Atatürk University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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