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Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy

Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04693013
Enrollment
84
Registered
2021-01-05
Start date
2021-01-01
Completion date
2024-04-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Episiotomy Wound, Perineum; Injury

Brief summary

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.

Interventions

DEVICEVirtual Reality for Anxiety Reduction

Virtual Reality for Anxiety Reduction during suturing of perineum

Sponsors

Ziv Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Post-partum vaginal delivery, spontaneous or instrumental * Episiotomy or 1st or 2nd degree perineal tear * informed consent

Exclusion criteria

* Cesarean delivery * 3rd or 4th degree perineal tear * no informed consent

Design outcomes

Primary

MeasureTime frameDescription
Anxiety LevelImmediately after procedurequestionairre

Secondary

MeasureTime frameDescription
Pain LevelImmediately after procedurequestionairre

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026