NCT07403526

Brief Summary

The goal of this randomized controlled trial was to evaluate whether Deliberate Virtual Reality (VR) training can improve surgical skills, knowledge, and confidence in performing postpartum hysterectomy among junior-level Zambian physicians in training. The main questions it aims to answer are:

  1. 1.Can VR-based surgical training improve technical surgical skills in a real-world setting?
  2. 2.Does Deliberate VR training enhance knowledge retention and confidence compared to standard clinical training?
  3. 3.The Deliberate VR group demonstrated significantly greater improvements in surgical knowledge, confidence, and OSATS scores compared to the standard training group.
  4. 4.VR training showed strong skill transfer to real-world surgical performance, suggesting that affordable and scalable VR training can help bridge surgical workforce gaps in resource-constrained settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

Virtual RealitySimulation TrainingSurgical EducationPostpartum HemorrhageHysterectomyObstetric Surgical ProceduresMaternal Health ServicesGlobal HealthClinical CompetenceMedical EducationRandomized Controlled TrialCapacity BuildingEducational TechnologyComputer-Assisted InstructionSkill AcquisitionSub-Saharan AfricaZambiaLow-Resource Settings

Outcome Measures

Primary Outcomes (1)

  • Change in Postpartum Hysterectomy Surgical Skill Performance

    The primary outcome measure is the change in surgical skill performance as measured by Objective Structured Assessment of Technical Skills scale, a validated tool for assessing surgical performance. Scores are based on technical proficiency, respect for tissue, instrument handling, and procedural knowledge, as assessed by blinded evaluators reviewing video-recorded surgical performances on a high-fidelity mannequin. The Objective Structured Assessment of Technical Skills scale consists of seven subscales assessing different aspects of surgical performance. Each subscale is rated on a 5-point Likert scale (1 = poor performance, 5 = excellent performance). The total score is the sum of all seven subscales, ranging from 7 (lowest possible) to 35 (highest possible). Higher scores indicate better surgical skill performance.

    Baseline (pre-training) and post-training (Day 10)

Secondary Outcomes (2)

  • Change in Postpartum Hemorrhage Knowledge

    Baseline and post-training (Day 10)

  • Change in Surgical Confidence Ratings

    Baseline and post-training (Day 10)

Other Outcomes (1)

  • Correlation Between VR Training Engagement and Surgical Performance

    Throughout the 9-day training period

Study Arms (2)

Deliberate Virtual Reality (VR) Training

EXPERIMENTAL

Participants in this arm underwent Deliberate Virtual Reality (VR) Training, a structured 9-day VR-based curriculum designed to improve surgical knowledge, technical skills, and confidence in performing postpartum hysterectomy. The training used interactive VR simulations, real-time performance feedback, and deliberate practice principles to enhance competency.

Behavioral: Deliberate Virtual Reality (VR) Training

Standard Clinical Training

ACTIVE COMPARATOR

Participants initially received standard clinical education on postpartum hysterectomy through traditional clinical training at their assigned hospitals. This included observation, supervised hands-on practice, and self-directed study without VR simulation. After completing the initial training phase, these participants crossed over to the Deliberate VR Training for an additional 9-day VR-based training program.

Behavioral: Standard Clinical Training

Interventions

Deliberate VR Training is a self-guided, interactive virtual reality-based training program focused on surgical skill acquisition. The VR simulation includes step-by-step procedural guidance, performance tracking, and self-reflection exercises for postpartum hysterectomy training. Participants practiced daily, receiving objective feedback on surgical accuracy and technique. The intervention lasted 9 days, with 6-hour daily training sessions.

Deliberate Virtual Reality (VR) Training

Standard Clinical Training followed a traditional mentor-based surgical training model at tertiary hospitals. Training included clinical observation, procedural discussions, and hands-on practice under supervision. Unlike the Deliberate VR group, participants did not have access to structured virtual reality simulation during the initial phase. Following post-training assessment, all participants in this arm crossed over to complete the Deliberate VR Training program. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Standard Clinical Training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Junior-level Zambian physicians.
  • Recent graduates of the General Medical Officers (GMO) training program or first-year Obstetrics and Gynecology residents.
  • Within the first 18 months of their training at public hospitals in Lusaka, Zambia.
  • Actively involved in the clinical and surgical management of postpartum hemorrhage (PPH).
  • Available for the full duration of the 9-day training period.
  • Provided verbal agreement to participate after being informed about the study objectives and procedures.

You may not qualify if:

  • Previously completed formal postpartum hysterectomy training.
  • Had prior experience with virtual reality (VR)-based surgical training.
  • Unable to commit to the full 9-day training schedule.
  • Did not receive permission from clinical supervisors to participate.
  • Had a medical condition or visual impairment that prevented the use of VR equipment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia, Zambia

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Sullivan, MD, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluators assessing surgical performance using OSATS scores were blinded to group assignment to minimize bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: This randomized controlled trial (RCT) with a crossover design assessed the effectiveness of Deliberate VR Training for postpartum hysterectomy training. The intervention included a 9-day, structured VR-based training program, real-time feedback, and skill assessment. Surgical skill assessments were conducted using Objective Structured Assessment of Technical Skills (OSATS) scores, based on video recordings of surgical procedures on lifelike mannequins.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 11, 2026

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) from this study will not be shared due to small sample size and participant confidentiality. The data collected includes sensitive training performance assessments and recorded surgical evaluations, which are not designed for public release.

Locations