Perineum; InjuryNCT04693013
Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy
A study testing Virtual Reality for Anxiety Reduction in people with Perineum; Injury and Episiotomy Wound, run by Ziv Hospital at 1 site in Israel.
Trial summary
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perineum; Injury, Episiotomy Wound, Anxiety
- What is being tested?
- Virtual Reality for Anxiety Reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2021to 30 Apr 2024
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-partum vaginal delivery, spontaneous or instrumental
- Episiotomy or 1st or 2nd degree perineal tear
- informed consent
Who cannot join
- Cesarean delivery
- 3rd or 4th degree perineal tear
- no informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
David Peleg
Safed, 13100
David Peleg, MD, 0506263782, david.p@ziv.gov.il
About this study
Official title: Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
Read the detailed description
Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman.
The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level.
84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS.
Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.
- Conditions
- Perineum; Injury, Episiotomy Wound, Anxiety
- Being tested
- Virtual Reality for Anxiety Reduction
- Medical subject headings
- Wounds and Injuries, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality for Anxiety ReductionDevice
Virtual Reality for Anxiety Reduction during suturing of perineum
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | use of virtual reality (VR) Receives: Device: Virtual Reality for Anxiety Reduction |
| Control | No intervention | no use of VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
questionairre
Measured: Immediately after procedure
Secondary outcomes (1)
Pain Level
questionairre
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineum; InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Peleg, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693013
- Sponsor's protocol ID
- 0103-20-ZIV
- Status last verified
- Jul 2023
- First submitted
- 31 Dec 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration
- ClinicalTrials.gov ID
- NCT04693013
- Acronym / sponsor ID
- 0103-20-ZIV
- Conditions
- Perineum; Injury, Episiotomy Wound, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 5 Jan 2021 (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.
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
Detailed description
Perineal lacerations and episiotomies are common after vaginal birth. Surgical repair of these conditions can cause discomfort and anxiety for the post-partum woman.
The purpose of this research is to determine if the use of virtual reality (VR) during repair of a perineal laceration or episiotomy can decrease the anxiety level of the woman. Other parameters that will be measured will be vital signs, time of procedure, and pain level.
84 eligible healthy women after spontaneous or instrumental vaginal birth will be enrolled. Allocation will be randomized by previous sealed envelopes. 42 in the VR group and 42 in the control group. The 42 women in the VR group will have the device placed band in use before the onset of the procedure. Anxiety level will be measured post-procedure by (STAI) State Inventory Anxiety Trait. Pain will be measure by VAS.
Assuming a significant anxiety level of 60% in women undergoing repair of a perineal laceration of episiotomy, in order to demonstrate a reduction to 30% in women using VR with a power of 80% and alpha of 0.05, 42 women will be needed in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: Virtual Reality for Anxiety Reductionuse of virtual reality (VR) |
| Control | No intervention | –no use of VR |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post-partum vaginal delivery, spontaneous or instrumental
- Episiotomy or 1st or 2nd degree perineal tear
- informed consent
Key exclusion criteria (3 listed)
- Cesarean delivery
- 3rd or 4th degree perineal tear
- no informed consent
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 Reality for Anxiety ReductionVirtual Reality for Anxiety Reduction during suturing of perineum | Device | Interventional |
Primary outcome
Anxiety Level
Time frame: Immediately after procedure
questionairre
1 secondary outcome
Pain Level
Time frame: Immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
Related trials for Perineum; Injury
Recruiting
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
Not yet recruiting
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
Perineal Trauma
Not yet recruiting
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
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.
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 for Anxiety Reduction in people with Perineum; Injury and Episiotomy Wound, run by Ziv Hospital at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: Immediately after procedure). 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 25 Jul 2023.