EpisiotomyNCT07510477
Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair
A study testing Breastfeeding and Skin-to-Skin Contact, Virtual Reality (VR) Goggles and Rhythmic Stress Ball Application in people with Episiotomy and Breastfeeding, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Breastfeeding, Virtual Reality
- What is being tested?
- Breastfeeding and Skin-to-Skin Contact, Virtual Reality (VR) Goggles and Rhythmic Stress Ball Application
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Nazilli State Hospital
Aydin, Nazilli, 09800
Gizem Fikriye Kırkız, Midwife/PhD Candidate, 05350343162, gfkirkiz@gmail.com
About this study
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
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:
Read more
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.
Read the 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.
- Conditions
- Episiotomy, Breastfeeding, Virtual Reality, Virtual Goggles, Anxiety, Cortisol
- Being tested
- Breastfeeding and Skin-to-Skin Contact, Virtual Reality (VR) Goggles, Rhythmic Stress Ball Application
- Keywords
- Breastfeeding, Virtual Reality, Stress Ball, Midwifery Care, Primiparous Women, Randomized Controlled Trial, Salivary Cortisol, Episiotomy, Episiotomy Repair
- Medical subject headings
- Breast Feeding, Anxiety Disorders, Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding and Skin-to-Skin ContactProcedure or surgery
Also called Early Breastfeeding, SSC
Midwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure.
Virtual Reality (VR) GogglesDevice
Also called VR, Visual Distraction
Use of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair.
Rhythmic Stress Ball ApplicationBehavioural
Also called Squeeze Ball
A physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Breastfeeding and Skin-to-Skin Contact |
| 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. Receives: Device: Virtual Reality (VR) Goggles |
| 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. Receives: Behavioral: Rhythmic Stress Ball Application |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).
Secondary outcomes (2)
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.
Measured: 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: Measured once between 6 and 24 hours after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Fikriye Kırkız, Aydin Adnan Menderes University
- Investigators
- Ayden ÇOBAN, PhD, Prof., Study director, AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510477
- Sponsor's protocol ID
- 2025/2
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34962008Yanes 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.
PubMed 30027283Spielberger, 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.
PubMed 37404226Hellhammer 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.
PubMed 19095358Cline 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.
PubMed 1437591
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07510477
- Acronym / sponsor ID
- 2025/2
- Conditions
- Episiotomy, Breastfeeding, Virtual Reality, Virtual Goggles, Anxiety, Cortisol
- Keywords
- Breastfeeding, Virtual Reality, Stress Ball, Midwifery Care, Primiparous Women, Randomized Controlled Trial, Salivary Cortisol, Episiotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding | Experimental | Procedure: Breastfeeding and Skin-to-Skin ContactThe 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 | Device: Virtual Reality (VR) GogglesThis 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. |
| Stress Ball | Experimental | Behavioral: Rhythmic Stress Ball ApplicationThis 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding and Skin-to-Skin ContactAlso: Early Breastfeeding, SSCMidwife-supported breastfeeding and skin-to-skin contact initiated before episiotomy repair and maintained throughout the procedure. | Procedure or surgery | Breastfeeding |
| Virtual Reality (VR) GogglesAlso: VR, Visual DistractionUse of VR goggles to provide relaxing visual and auditory nature content as a sensory distraction during episiotomy repair. | Device | Virtual Reality (VR) |
| Rhythmic Stress Ball ApplicationAlso: Squeeze BallA physical distraction technique where participants rhythmically squeeze and release a ball while counting from 1 to 3 throughout the procedure. | Behavioural | Stress Ball |
Primary outcome
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 34962008Zou 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.
- Background: PubMed 30027283Yanes 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.
- BackgroundSpielberger, C. D., Gorsuch, R. L., & Lushene. R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- BackgroundKarakaplan, S., & Yildiz, H. (2010). Development of the Postpartum Comfort Scale. Maltepe University Journal of Nursing Science and Art, 3(1), 55-65.
- Background: PubMed 37404226Orhan 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.
- Background: PubMed 19095358Hellhammer 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.
- Background: PubMed 1437591Cline 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayden ÇOBAN, PhD, Prof. study director
AydiAdnan Menderes University, Faculty of Health Sciences, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding and Skin-to-Skin Contact, Virtual Reality (VR) Goggles and Rhythmic Stress Ball Application in people with Episiotomy and Breastfeeding, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Fikriye KIRKIZ, Midwife/PhD Candidate (+90 5350343162, gfkirkiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for Pain (VAS-P) (time frame: Measured twice: baseline (immediately before episiotomy repair) and post-intervention (immediately after episiotomy repair).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510477, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.