Perineal PainNCT07499011
Comparison Between Virtual Reality and Stress Ball Intervention In Managing Pain During Episiotomy Repair
A study testing virtual reality, stress ball and Virtual Reality Plus Stress Ball in people with Perineal Pain, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study is a four-arm randomized controlled trial designed to evaluate the effectiveness of non-pharmacological interventions for pain management during episiotomy repair among women undergoing vaginal birth. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Perineal Pain
- What is being tested?
- virtual reality, stress ball and Virtual Reality Plus Stress Ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIraq
- Study dates
- 16 Dec 2025to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 42 years
- Able to communicate and understand the study procedures
- No vision, hearing, or perception problems
- No physical problems preventing squeezing a stress ball
- No diabetes mellitus
- Undergoing episiotomy repair after vaginal birth
- Willing to participate and provide informed consent
Who cannot join
- Pre-existing chronic pain conditions
- Severe perineal tear (3rd or 4th degree)
- Development of any complication during the procedure
- Women who did not consent to participate in the study
- Women undergoing episiotomy repair with local anesthetic infiltration
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Feminine and Children Teaching Hospital and al _Rumaitha Hospital
Samawah, Muthanna Governorate
About this study
Official title: Comparison Between Virtual Reality and Stress Ball Intervention in Managing Pain During Episiotomy Repair
This study is a four-arm randomized controlled trial designed to evaluate the effectiveness of non-pharmacological interventions for pain management during episiotomy repair among women undergoing vaginal birth. Participants will be allocated to one of four groups: virtual reality, stress ball, combined virtual reality plus stress ball, or control. The virtual reality intervention is intended to provide immersive distraction, while the stress ball offers tactile distraction; the combined group receives both interventions simultaneously. The control group receives routine care only. The primary outcome is pain intensity measured during the procedure using the Visual Analog Scale. Outcome data will be compared across groups to identify the most effective intervention for reducing pain during episiotomy repair. This study may provide evidence for practical, safe, and low-cost supportive strategies that can improve maternal comfort during childbirth procedures.
- Conditions
- Perineal Pain
- Being tested
- virtual reality, stress ball, Virtual Reality Plus Stress Ball
- Keywords
- Virtual Reality, stress ball, non-pharmacology, episiotomy repair, perineal repair, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
Use of virtual reality goggles during episiotomy repair as a non-pharmacological pain management intervention.
stress ballOther
Use of a stress ball during episiotomy repair as a non-pharmacological pain management intervention.
Virtual Reality Plus Stress BallOther
Combined use of virtual reality goggles and a stress ball during episiotomy repair as a non-pharmacological pain management intervention.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in this group will receive virtual reality during episiotomy repair in addition to routine care. Receives: Device: virtual reality |
| Stress Ball Group | Experimental | Participants in this group will use a stress ball during episiotomy repair in addition to routine care. Receives: Other: stress ball |
| virtual reality and stress ball | Experimental | Participants in this group will receive combined virtual reality and stress ball intervention during episiotomy repair in addition to routine care. Receives: Other: Virtual Reality Plus Stress Ball |
| control group | No intervention | Participants in this group will receive routine care during episiotomy repair without virtual reality or stress ball intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured using the Visual Analog Scale
Pain intensity during episiotomy repair will be assessed using the Visual Analog Scale 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst pain possible. Higher scores indicate greater pain intensity. Pain scores will be compared cross the virtual reality, stress ball, combined virtual reality plus stress ball, and control groups
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start16 Dec 2025
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Abdulameer Fadhala, University of Baghdad
- Investigators
- Nuha adel Ibrahim, Dr, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499011
- Sponsor's protocol ID
- VRSB-EPI-RCT-2026-01
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Virtual Reality and Stress Ball Intervention in Managing Pain During Episiotomy Repair
- ClinicalTrials.gov ID
- NCT07499011
- Acronym / sponsor ID
- VRSB-EPI-RCT-2026-01
- Conditions
- Perineal Pain
- Keywords
- Virtual Reality, stress ball, non-pharmacology, episiotomy repair, perineal repair, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 27 Mar 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.
This study is a four-arm randomized controlled trial designed to evaluate the effectiveness of non-pharmacological interventions for pain management during episiotomy repair among women undergoing vaginal birth. Participants will be allocated to one of four groups: virtual reality, stress ball, combined virtual reality plus stress ball, or control. The virtual reality intervention is intended to provide immersive distraction, while the stress ball offers tactile distraction; the combined group receives both interventions simultaneously. The control group receives routine care only. The primary outcome is pain intensity measured during the procedure using the Visual Analog Scale. Outcome data will be compared across groups to identify the most effective intervention for reducing pain during episiotomy repair. This study may provide evidence for practical, safe, and low-cost supportive strategies that can improve maternal comfort during childbirth procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: virtual realityParticipants in this group will receive virtual reality during episiotomy repair in addition to routine care. |
| Stress Ball Group | Experimental | Other: stress ballParticipants in this group will use a stress ball during episiotomy repair in addition to routine care. |
| virtual reality and stress ball | Experimental | Other: Virtual Reality Plus Stress BallParticipants in this group will receive combined virtual reality and stress ball intervention during episiotomy repair in addition to routine care. |
| control group | No intervention | –Participants in this group will receive routine care during episiotomy repair without virtual reality or stress ball intervention. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women aged 18 to 42 years
- Able to communicate and understand the study procedures
- No vision, hearing, or perception problems
- No physical problems preventing squeezing a stress ball
- No diabetes mellitus
Key exclusion criteria (5 listed)
- Pre-existing chronic pain conditions
- Severe perineal tear (3rd or 4th degree)
- Development of any complication during the procedure
- Women who did not consent to participate in the study
- Women undergoing episiotomy repair with local anesthetic infiltration
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 |
|---|---|---|
| virtual realityUse of virtual reality goggles during episiotomy repair as a non-pharmacological pain management intervention. | Device | Virtual Reality Group |
| stress ballUse of a stress ball during episiotomy repair as a non-pharmacological pain management intervention. | Other | Stress Ball Group |
| Virtual Reality Plus Stress BallCombined use of virtual reality goggles and a stress ball during episiotomy repair as a non-pharmacological pain management intervention. | Other | virtual reality and stress ball |
Primary outcome
Pain intensity measured using the Visual Analog Scale
Time frame: Periprocedural
Pain intensity during episiotomy repair will be assessed using the Visual Analog Scale 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst pain possible. Higher scores indicate greater pain intensity. Pain scores will be compared cross the virtual reality, stress ball, combined virtual reality plus stress ball, and control groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Perineal Pain
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Pudendal Nerve Block for Pain Relief During Episiotomy Repair
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Active, not recruiting
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
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Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
Episiotomy, Platelet Rich Plasma (PRP)
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. This study is not recruiting at the moment.
Nuha adel Ibrahim, Dr study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality, stress ball and Virtual Reality Plus Stress Ball in people with Perineal Pain, run by University of Baghdad at 1 site in Iraq.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 6 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 Iraq. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured using the Visual Analog Scale (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.