Medical TrainingNCT04937257
Virtual Reality on Efficacy of Donning and Doffing PPE
A study testing Virtual Reality and E-module in people with Medical Training, run by Montefiore Medical Center at 1 site in United States.
Trial summary
All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Training
- What is being tested?
- Virtual Reality and E-module
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 27 Jan 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
- Associates affiliated with the Montefiore Medical Center.
- Medical Students at the Albert Einstein College of Medicine.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Einstein Center for Innovation in Simulation
The Bronx, New York, 10461
About this study
Official title: Comparison of a Virtual Reality Versus an E-Module on Efficacy of Donning and Doffing PPE: A Randomized Control Trial
All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2). In-person, hands-on training tends to be preferred, however staff shortages limit feasibility and contamination still occurs (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online (5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).
Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.
The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.
Read the detailed description
The COVID-19 (Coronavirus Disease 2019) pandemic highlighted concerns regarding personal protective equipment (PPE) utilization in hospitals (10,11). When used correctly, PPE can prevent COVID-19 infection amongst exposed healthcare workers (12,13) . Evidence suggests that up to 90% of doffing procedures are performed incorrectly (14). This failure rate has been linked to healthcare workers being more likely to contract COVID-19 compared to the general community (15). As a result, authorities have turned to increased training as a potential solution (16).
All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2) In-person, hands-on training tends to be preferred, however, staff shortages limit feasibility and contamination still occurs 82% of the time (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online(5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).
Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.
The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.
- Conditions
- Medical Training
- Being tested
- Virtual Reality, E-module
- Keywords
- Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
The training included the following in the specified order: (1) A tutorial with an introduction to the program and a overview of the correct donning and doffing sequence, based on Center for Disease Control (CDC) guidelines, (2) a training mode to practice the correct sequences with step-wise feedback, and (3) a testing mode that repeated until the sequence was completed perfectly without any mistakes. A study member was present to assist with the device and record the duration of training.
E-moduleOther
The instructional video included step-by-step instruction and demonstration of adequate donning and doffing procedures. The 14-slide presentation contained the same content as used by the home institution for competency training, based on Center for Disease Control (CDC) guidelines. Participants were instructed to review the material however they liked and their duration of training was recorded.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Active comparator | Participants randomized to the immersive virtual reality study arm, considered the "intervention group" received training on donning and doffing PPE using a program developed by Axon Park Inc. (California, USA) Receives: Other: Virtual Reality |
| E-module | Placebo comparator | Participants randomized to the e-module study arm, considered the "control group" received training on donning and doffing PPE using an e-module containing a video and slide show. Receives: Other: E-module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Donning and Doffing Performance
Donning and doffing performance was evaluated using a checklist based on Center for Disease Control (CDC) guidelines. The performance checklist consisted of separate sections for donning and doffing. Scoring for each step was based on (1) completion and (2) correct sequence. All points are totaled for a maximum possible score of 64 points and minimum possible score of 0 points. A higher score indicates a better outcome.
Measured: Immediately after the intervention
Secondary outcomes (2)
Subgroup analysis
Subgroup analyses were based on the most common occupations listed. The overall study sample was reduced into three groups: medical students, residents, and all other participants.
Measured: Immediately after the intervention
Participant experience
Analysis of survey data compared participants' perceived preparedness, perceived confidence, and degree of distraction during training.
Measured: Baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start16 Nov 2020
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Medical TrainingStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc J. Gibber, Montefiore Medical Center
- Investigators
- Farrukh Jafri, MD, Principal investigator, Albert Einstein College of MedicineMarc Gibber, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937257
- Sponsor's protocol ID
- 2020-11936
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Occupational Safety and Health Administration. OSHA Best Practices for HospitalBased First Receivers of Victims from Mass Casualty Incidents Involving the Release of Hazardous Substances. US Department of Labor, OSHA 3249-08N; 2005. https:// www.osha.gov/Publications/osha3249.pdf. Accessed July 30, 2020.
Kang J, O'Donnell JM, Colaianne B, Bircher N, Ren D, Smith KJ. Use of personal protective equipment among health care personnel: Results of clinical observations and simulations. Am J Infect Control. 2017 Jan 1;45(1):17-23. doi: 10.1016/j.ajic.2016.08.011.
PubMed 28065328Barratt R, Shaban RZ, Gilbert GL. Characteristics of personal protective equipment training programs in Australia and New Zealand hospitals: A survey. Infect Dis Health. 2020 Nov;25(4):253-261. doi: 10.1016/j.idh.2020.05.005. Epub 2020 Jun 26.
PubMed 32600965Kirch DG, Petelle K. Addressing the Physician Shortage: The Peril of Ignoring Demography. JAMA. 2017 May 16;317(19):1947-1948. doi: 10.1001/jama.2017.2714. No abstract available.
PubMed 28319233Salway RJ, Williams T, Londono C, Roblin P, Koenig K, Arquilla B. Comparing Training Techniques in Personal Protective Equipment Use. Prehosp Disaster Med. 2020 Aug;35(4):364-371. doi: 10.1017/S1049023X20000564. Epub 2020 May 11.
PubMed 32390583L Perna AR, R Boruch, N Wang, J Scull, C Evans, S Ahmad. The life cycle of a million MOOC users. MOOC Research Initiative Conference 5; 2013.
Samadbeik M, Yaaghobi D, Bastani P, Abhari S, Rezaee R, Garavand A. The Applications of Virtual Reality Technology in Medical Groups Teaching. J Adv Med Educ Prof. 2018 Jul;6(3):123-129.
PubMed 30013996Christensen L, Rasmussen CS, Benfield T, Franc JM. A Randomized Trial of Instructor-Led Training Versus Video Lesson in Training Health Care Providers in Proper Donning and Doffing of Personal Protective Equipment. Disaster Med Public Health Prep. 2020 Aug;14(4):514-520. doi: 10.1017/dmp.2020.56. Epub 2020 Mar 30.
PubMed 32223776Hung PP, Choi KS, Chiang VC. Using interactive computer simulation for teaching the proper use of personal protective equipment. Comput Inform Nurs. 2015 Feb;33(2):49-57. doi: 10.1097/CIN.0000000000000125.
PubMed 25521788McCarthy R, Gino B, d'Entremont P, Barari A, Renouf TS. The Importance of Personal Protective Equipment Design and Donning and Doffing Technique in Mitigating Infectious Disease Spread: A Technical Report. Cureus. 2020 Dec 14;12(12):e12084. doi: 10.7759/cureus.12084.
PubMed 33489502John A, Tomas ME, Hari A, Wilson BM, Donskey CJ. Do medical students receive training in correct use of personal protective equipment? Med Educ Online. 2017;22(1):1264125. doi: 10.1080/10872981.2017.1264125.
PubMed 28178912Suzuki T, Hayakawa K, Ainai A, Iwata-Yoshikawa N, Sano K, Nagata N, Suzuki T, Wakimoto Y, Akiyama Y, Miyazato Y, Nakamura K, Ide S, Nomoto H, Nakamoto T, Ota M, Moriyama Y, Sugiki Y, Saito S, Morioka S, Ishikane M, Kinoshita N, Kutsuna S, Ohmagari N. Effectiveness of personal protective equipment in preventing severe acute respiratory syndrome coronavirus 2 infection among healthcare workers. J Infect Chemother. 2021 Jan;27(1):120-122. doi: 10.1016/j.jiac.2020.09.006. Epub 2020 Sep 9.
PubMed 32988731Karlsson U, Fraenkel CJ. Covid-19: risks to healthcare workers and their families. BMJ. 2020 Oct 28;371:m3944. doi: 10.1136/bmj.m3944. No abstract available.
PubMed 33115772Phan LT, Maita D, Mortiz DC, Weber R, Fritzen-Pedicini C, Bleasdale SC, Jones RM; CDC Prevention Epicenters Program. Personal protective equipment doffing practices of healthcare workers. J Occup Environ Hyg. 2019 Aug;16(8):575-581. doi: 10.1080/15459624.2019.1628350. Epub 2019 Jul 10.
PubMed 31291152Nguyen LH, Drew DA, Graham MS, Joshi AD, Guo CG, Ma W, Mehta RS, Warner ET, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Sudre CH, Cardoso MJ, Wolf J, Spector TD, Ourselin S, Steves CJ, Chan AT; COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet Public Health. 2020 Sep;5(9):e475-e483. doi: 10.1016/S2468-2667(20)30164-X. Epub 2020 Jul 31.
PubMed 32745512
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Virtual Reality Versus an E-Module on Efficacy of Donning and Doffing PPE: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04937257
- Acronym / sponsor ID
- 2020-11936
- Conditions
- Medical Training
- Keywords
- Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 24 Jun 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.
All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2). In-person, hands-on training tends to be preferred, however staff shortages limit feasibility and contamination still occurs (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online (5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).
Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.
The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.
Detailed description
The COVID-19 (Coronavirus Disease 2019) pandemic highlighted concerns regarding personal protective equipment (PPE) utilization in hospitals (10,11). When used correctly, PPE can prevent COVID-19 infection amongst exposed healthcare workers (12,13) . Evidence suggests that up to 90% of doffing procedures are performed incorrectly (14). This failure rate has been linked to healthcare workers being more likely to contract COVID-19 compared to the general community (15). As a result, authorities have turned to increased training as a potential solution (16).
All front-line healthcare workers in the United States must receive PPE training but there is no gold standard for doing so(1). Training methods vary, with the conventional approaches being in-person or video presentations (2) In-person, hands-on training tends to be preferred, however, staff shortages limit feasibility and contamination still occurs 82% of the time (2-4). Online modules and videos are also commonly utilized but pose problems including lack of student engagement, reduced accountability, and the limitations of teaching hands-on skills online(5,6). Nonetheless, immersive methods with active involvement and feedback have proven superior, but PPE shortages and social distancing guidelines limit their use (2).
Virtual reality (VR) is a potential alternative, offering similar benefits to in-person training, such as immersion and feedback, while minimizing barriers related to timing, social distancing, and equipment shortages(7). Importantly, VR allows for repetitive practice while preserving PPE for clinical interactions. These qualities make VR a viable alternative, although its impact on donning and doffing quality is unknown. Studies regarding PPE training have found in-person and video methods to be comparable and computer simulations to effectively complement in-person training (5, 8, 9). However, to our knowledge, this is the first study to investigate the use of VR in PPE training.
The investigators proposed a randomized, blinded intervention-control trial comparing VR versus e-module training in the teaching of donning and doffing PPE in associates and students affiliated with the Montefiore Medical Center.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Active comparator | Other: Virtual RealityParticipants randomized to the immersive virtual reality study arm, considered the "intervention group" received training on donning and doffing PPE using a program developed by Axon Park Inc. (California, USA) |
| E-module | Placebo comparator | Other: E-moduleParticipants randomized to the e-module study arm, considered the "control group" received training on donning and doffing PPE using an e-module containing a video and slide show. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Associates affiliated with the Montefiore Medical Center.
- Medical Students at the Albert Einstein College of Medicine.
Key exclusion criteria (1 listed)
- None.
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 RealityThe training included the following in the specified order: (1) A tutorial with an introduction to the program and a overview of the correct donning and doffing sequence, based on Center for Disease Control (CDC) guidelines, (2) a training mode to practice the correct sequences with step-wise feedback, and (3) a testing mode that repeated until the sequence was completed perfectly without any mistakes. A study member was present to assist with the device and record the duration of training. | Other | Virtual Reality |
| E-moduleThe instructional video included step-by-step instruction and demonstration of adequate donning and doffing procedures. The 14-slide presentation contained the same content as used by the home institution for competency training, based on Center for Disease Control (CDC) guidelines. Participants were instructed to review the material however they liked and their duration of training was recorded. | Other | E-module |
Primary outcome
Overall Donning and Doffing Performance
Time frame: Immediately after the intervention
Donning and doffing performance was evaluated using a checklist based on Center for Disease Control (CDC) guidelines. The performance checklist consisted of separate sections for donning and doffing. Scoring for each step was based on (1) completion and (2) correct sequence. All points are totaled for a maximum possible score of 64 points and minimum possible score of 0 points. A higher score indicates a better outcome.
2 secondary outcomes
Subgroup analysis
Time frame: Immediately after the intervention
Participant experience
Time frame: Baseline, pre-intervention and immediately after the intervention
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 24 Jun 2021.
- BackgroundOccupational Safety and Health Administration. OSHA Best Practices for HospitalBased First Receivers of Victims from Mass Casualty Incidents Involving the Release of Hazardous Substances. US Department of Labor, OSHA 3249-08N; 2005. https:// www.osha.gov/Publications/osha3249.pdf. Accessed July 30, 2020.
- Background: PubMed 28065328Kang J, O'Donnell JM, Colaianne B, Bircher N, Ren D, Smith KJ. Use of personal protective equipment among health care personnel: Results of clinical observations and simulations. Am J Infect Control. 2017 Jan 1;45(1):17-23. doi: 10.1016/j.ajic.2016.08.011.
- Background: PubMed 32600965Barratt R, Shaban RZ, Gilbert GL. Characteristics of personal protective equipment training programs in Australia and New Zealand hospitals: A survey. Infect Dis Health. 2020 Nov;25(4):253-261. doi: 10.1016/j.idh.2020.05.005. Epub 2020 Jun 26.
- Background: PubMed 28319233Kirch DG, Petelle K. Addressing the Physician Shortage: The Peril of Ignoring Demography. JAMA. 2017 May 16;317(19):1947-1948. doi: 10.1001/jama.2017.2714. No abstract available.
- Background: PubMed 32390583Salway RJ, Williams T, Londono C, Roblin P, Koenig K, Arquilla B. Comparing Training Techniques in Personal Protective Equipment Use. Prehosp Disaster Med. 2020 Aug;35(4):364-371. doi: 10.1017/S1049023X20000564. Epub 2020 May 11.
- BackgroundL Perna AR, R Boruch, N Wang, J Scull, C Evans, S Ahmad. The life cycle of a million MOOC users. MOOC Research Initiative Conference 5; 2013.
- Background: PubMed 30013996Samadbeik M, Yaaghobi D, Bastani P, Abhari S, Rezaee R, Garavand A. The Applications of Virtual Reality Technology in Medical Groups Teaching. J Adv Med Educ Prof. 2018 Jul;6(3):123-129.
- Background: PubMed 32223776Christensen L, Rasmussen CS, Benfield T, Franc JM. A Randomized Trial of Instructor-Led Training Versus Video Lesson in Training Health Care Providers in Proper Donning and Doffing of Personal Protective Equipment. Disaster Med Public Health Prep. 2020 Aug;14(4):514-520. doi: 10.1017/dmp.2020.56. Epub 2020 Mar 30.
- Background: PubMed 25521788Hung PP, Choi KS, Chiang VC. Using interactive computer simulation for teaching the proper use of personal protective equipment. Comput Inform Nurs. 2015 Feb;33(2):49-57. doi: 10.1097/CIN.0000000000000125.
- Background: PubMed 33489502McCarthy R, Gino B, d'Entremont P, Barari A, Renouf TS. The Importance of Personal Protective Equipment Design and Donning and Doffing Technique in Mitigating Infectious Disease Spread: A Technical Report. Cureus. 2020 Dec 14;12(12):e12084. doi: 10.7759/cureus.12084.
- Background: PubMed 28178912John A, Tomas ME, Hari A, Wilson BM, Donskey CJ. Do medical students receive training in correct use of personal protective equipment? Med Educ Online. 2017;22(1):1264125. doi: 10.1080/10872981.2017.1264125.
- Background: PubMed 32988731Suzuki T, Hayakawa K, Ainai A, Iwata-Yoshikawa N, Sano K, Nagata N, Suzuki T, Wakimoto Y, Akiyama Y, Miyazato Y, Nakamura K, Ide S, Nomoto H, Nakamoto T, Ota M, Moriyama Y, Sugiki Y, Saito S, Morioka S, Ishikane M, Kinoshita N, Kutsuna S, Ohmagari N. Effectiveness of personal protective equipment in preventing severe acute respiratory syndrome coronavirus 2 infection among healthcare workers. J Infect Chemother. 2021 Jan;27(1):120-122. doi: 10.1016/j.jiac.2020.09.006. Epub 2020 Sep 9.
- Individual participant dataSharing planned: No
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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.
Farrukh Jafri, MD principal investigator
Albert Einstein College of Medicine
Marc Gibber, MD principal investigator
Montefiore Medical Center
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 and E-module in people with Medical Training, run by Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 1 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 24 Jun 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Overall Donning and Doffing Performance (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937257, which also lists 16 linked publications.
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 24 Jun 2021.