Hysterectomy (MeSH nr: E04.950.300.399)NCT07403526
Transforming Global Surgery Capacity and Capability Through Affordable Virtual Reality
A study testing Deliberate Virtual Reality (VR) Training and Standard Clinical Training in people with Hysterectomy (MeSH nr: E04.950.300.399), run by Southern Methodist University at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy (MeSH nr: E04.950.300.399)
- What is being tested?
- Deliberate Virtual Reality (VR) Training and Standard Clinical Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteZambia
- Study dates
- 1 Sep 2021to 31 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- Can VR-based surgical training improve technical surgical skills in a real-world setting?
- Does Deliberate VR training enhance knowledge retention and confidence compared to standard clinical training?
Study Design: Researchers randomly assigned participants to either:
1 Deliberate VR Training (intervention group): A 9-day VR-based surgical training program 2. Standard Training (control group): Conventional clinical education
Participants underwent assessments of surgical skills, knowledge, and confidence before and after training using objective structured assessment of technical skills (OSATS) and knowledge exams.
Key Findings:
- The Deliberate VR group demonstrated significantly greater improvements in surgical knowledge, confidence, and OSATS scores compared to the standard training group.
- 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.
This study highlights VR-based training as a potential scalable solution to strengthen surgical capacity in maternal health, addressing workforce shortages and improving equitable access to essential surgical care.
Read the detailed description
This study evaluates the effectiveness of Deliberate Virtual Reality (VR) Training as an innovative educational intervention for enhancing surgical skills, knowledge retention, and confidence in postpartum hysterectomy management among junior physicians in Zambia. The study employs a randomized controlled trial (RCT) with a crossover design, ensuring that all participants ultimately experience the VR training.
Study Rationale and Background: Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality, particularly in low-resource settings where access to highly trained surgeons is limited. Traditional surgical training models rely on mentorship and hands-on experience, which may not be feasible in under-resourced clinical environments with limited faculty. Virtual reality offers a scalable, cost-effective alternative, allowing trainees to repeatedly practice surgical techniques in a controlled environment before real-world application.
Intervention Details: The Deliberate VR training model is a 9-day self-guided, simulation-based program designed to: Provide a structured, step-by-step approach to learning postpartum hysterectomy procedures. Utilize interactive VR environments that allow real-time assessment and feedback. Offer progress tracking and individualized goal-setting for surgical skill mastery. Incorporate reflection exercises to reinforce deliberate practice techniques.
Study Procedures: Participants were randomly assigned to two groups:
- Intervention Group: Immediate Deliberate VR Training.
- Control Group: Standard clinical training, followed by cross-over to VR training.
Outcomes:
- Primary outcomes include surgical proficiency (measured via OSATS scoring) and knowledge acquisition.
- Secondary outcomes assess confidence, skill retention, and real-world application in surgical settings.
Ethical Considerations: Ethical approval was obtained from University of Zambia Biomedical Research Ethics Committee, Southern Methodist University, University of North Carolina at Chapel Hill, and King's College London. Written informed consent was obtained from all participants. The study followed the Declaration of Helsinki guidelines for ethical research involving human participants.
Potential Impact The findings from this study may inform global health education strategies by demonstrating how low-cost VR interventions can strengthen surgical training, particularly in regions with surgical workforce shortages. If successful, this model could be adapted for other critical procedures and integrated into postgraduate medical training programs in resource-constrained settings.
- Conditions
- Hysterectomy (MeSH nr: E04.950.300.399)
- Being tested
- Deliberate Virtual Reality (VR) Training, Standard Clinical Training
- Keywords
- Virtual Reality, Simulation Training, Surgical Education, Postpartum Hemorrhage, Hysterectomy, Obstetric Surgical Procedures, Maternal Health Services, Global Health, Clinical Competence, Medical Education, Randomized Controlled Trial, Capacity Building, Educational Technology, Computer-Assisted Instruction, Skill Acquisition, Sub-Saharan Africa, Zambia, Low-Resource Settings
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deliberate Virtual Reality (VR) TrainingBehavioural
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.
Standard Clinical TrainingBehavioural
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.
________________________________________
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Clinical Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-training) and post-training (Day 10)
Secondary outcomes (2)
Change in Postpartum Hemorrhage Knowledge
Knowledge of postpartum hemorrhage management and postpartum hysterectomy procedures will be assessed using a 24-item multiple-choice Postpartum Hemorrhage Knowledge scale, developed from validated clinical content. Each question was either correct (1), or incorrect (0), with total scores ranging from 0 (low knowledge) to 24 (high knowledge).
Measured: Baseline and post-training (Day 10)
Change in Surgical Confidence Ratings
Self-reported confidence in performing a postpartum hysterectomy, assessed using a 10-point Likert scale on three sub-scales measuring perceived (1) ability in surgical execution, (2) clinical decision-making, and (3) anatomical knowledge. Scores on each sub-scale ranged from 1 (very low confidence) to 10 (very high confidence).
Measured: Baseline and post-training (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy (MeSH nr: E04.950.300.399)Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Richard Sullivan, MD, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403526
- Sponsor's protocol ID
- 21-102
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Global Surgery Capacity and Capability Through Affordable Virtual Reality
- ClinicalTrials.gov ID
- NCT07403526
- Acronym / sponsor ID
- 21-102
- Conditions
- Hysterectomy (MeSH nr: E04.950.300.399)
- Keywords
- Virtual Reality, Simulation Training, Surgical Education, Postpartum Hemorrhage, Hysterectomy, Obstetric Surgical Procedures, Maternal Health Services, Global Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Feb 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 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:
- Can VR-based surgical training improve technical surgical skills in a real-world setting?
- Does Deliberate VR training enhance knowledge retention and confidence compared to standard clinical training?
Study Design: Researchers randomly assigned participants to either:
1 Deliberate VR Training (intervention group): A 9-day VR-based surgical training program 2. Standard Training (control group): Conventional clinical education
Participants underwent assessments of surgical skills, knowledge, and confidence before and after training using objective structured assessment of technical skills (OSATS) and knowledge exams.
Key Findings:
- The Deliberate VR group demonstrated significantly greater improvements in surgical knowledge, confidence, and OSATS scores compared to the standard training group.
- 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.
This study highlights VR-based training as a potential scalable solution to strengthen surgical capacity in maternal health, addressing workforce shortages and improving equitable access to essential surgical care.
Detailed description
This study evaluates the effectiveness of Deliberate Virtual Reality (VR) Training as an innovative educational intervention for enhancing surgical skills, knowledge retention, and confidence in postpartum hysterectomy management among junior physicians in Zambia. The study employs a randomized controlled trial (RCT) with a crossover design, ensuring that all participants ultimately experience the VR training.
Study Rationale and Background: Postpartum hemorrhage (PPH) remains a leading cause of maternal mortality, particularly in low-resource settings where access to highly trained surgeons is limited. Traditional surgical training models rely on mentorship and hands-on experience, which may not be feasible in under-resourced clinical environments with limited faculty. Virtual reality offers a scalable, cost-effective alternative, allowing trainees to repeatedly practice surgical techniques in a controlled environment before real-world application.
Intervention Details: The Deliberate VR training model is a 9-day self-guided, simulation-based program designed to: Provide a structured, step-by-step approach to learning postpartum hysterectomy procedures. Utilize interactive VR environments that allow real-time assessment and feedback. Offer progress tracking and individualized goal-setting for surgical skill mastery. Incorporate reflection exercises to reinforce deliberate practice techniques.
Study Procedures: Participants were randomly assigned to two groups:
- Intervention Group: Immediate Deliberate VR Training.
- Control Group: Standard clinical training, followed by cross-over to VR training.
Outcomes:
- Primary outcomes include surgical proficiency (measured via OSATS scoring) and knowledge acquisition.
- Secondary outcomes assess confidence, skill retention, and real-world application in surgical settings.
Ethical Considerations: Ethical approval was obtained from University of Zambia Biomedical Research Ethics Committee, Southern Methodist University, University of North Carolina at Chapel Hill, and King's College London. Written informed consent was obtained from all participants. The study followed the Declaration of Helsinki guidelines for ethical research involving human participants.
Potential Impact The findings from this study may inform global health education strategies by demonstrating how low-cost VR interventions can strengthen surgical training, particularly in regions with surgical workforce shortages. If successful, this model could be adapted for other critical procedures and integrated into postgraduate medical training programs in resource-constrained settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Deliberate Virtual Reality (VR) Training | Experimental | Behavioral: Deliberate Virtual Reality (VR) TrainingParticipants 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. |
| Standard Clinical Training | Active comparator | Behavioral: Standard Clinical TrainingParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Deliberate Virtual Reality (VR) TrainingDeliberate 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. | Behavioural | Deliberate Virtual Reality (VR) Training |
| Standard Clinical TrainingStandard 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. ________________________________________ | Behavioural | Standard Clinical Training |
Primary outcome
Change in Postpartum Hysterectomy Surgical Skill Performance
Time frame: Baseline (pre-training) and post-training (Day 10)
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.
2 secondary outcomes
Change in Postpartum Hemorrhage Knowledge
Time frame: Baseline and post-training (Day 10)
Change in Surgical Confidence Ratings
Time frame: Baseline and post-training (Day 10)
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 11 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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.
Richard Sullivan, MD, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deliberate Virtual Reality (VR) Training and Standard Clinical Training in people with Hysterectomy (MeSH nr: E04.950.300.399), run by Southern Methodist University at 1 site in Zambia.
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 0 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 11 Feb 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 Zambia. 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?
Change in Postpartum Hysterectomy Surgical Skill Performance (time frame: Baseline (pre-training) and post-training (Day 10)). 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 11 Feb 2026.