Can mobile application-augmented reality improve better skills and knowledge in interventional pain management of lumbar facet joint with fluoroscopic guidance? Comparison with traditional method
| ISRCTN | ISRCTN17740832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17740832 |
- Submission date
- 21/01/2024
- Registration date
- 30/01/2024
- Last edited
- 07/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Pain is an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage. Various types of therapy, both pharmacological and non-pharmacological, are given, intervention is one option in pain management. However, it is often found that there are limitations between the knowledge provided and the clinical skills obtained during education as well as inadequate supporting infrastructure. This causes practitioners to feel less confident in taking action. Learning innovations using mobile applications and augmented reality through the M-eDU PAIN application can overcome these problems. M-eDU PAIN is a new mobile application focused on learning interventional pain management. This study aims to find out about increasing skills and knowledge in the lumbar facet joint using the mobile application with Augmented Reality as a learning method.
Who can participate?
Residents of anesthesiology and intensive care department at Dr Sardjito General Hospital Yogyakarta who met the inclusion and exclusion criteria
What does the study involve?
Residents will receive one of two learning methods of lumbar facet joint intervention, traditional methods or digital methods by using the mobile application M-eDU PAIN and augmented reality. All participants will be examined using knowledge tests and skill improvement will be measured.
What are the possible benefits and risks of participating?
Possible benefits of digital methods are faster and better improvement of knowledge and skill of lumbar facet joint intervention, while the potential risks are possible exposure to fluoroscopy radiation and time-consuming.
Where is the study run from?
Universitas Gadjah Mada (Indonesia)
When is the study starting and how long is it expected to run for?
November 2023 to April 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mahmud Mahmud, mahmudanestesi@ugm.ac.id
Contact information
Public, Scientific, Principal Investigator
Jalan Kesehatan no 1
Yogyakarta
55284
Indonesia
 ORCID ID |
0000-0002-7224-2637 |
|---|---|
| Phone | +62-8122697997 |
| mahmudanestesi@ugm.ac.id |
Study information
| Study design | Single-center single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 44915_PIS.pdf |
| Scientific title | Comparison of learning methods: mobile application-augmented reality with traditional learning for interventional pain management skills of lumbar facet joint with fluoroscopic guidance |
| Study objectives | Learning methods using mobile application with augmented reality can improve residents' skills and knowledge better than traditional learning for interventional pain management of lumbar facet joint with fluoroscopic guidance |
| Ethics approval(s) |
Approved 05/12/2023, Medical and Health Research Ethics Committee of Universitas Gadjah Mada (Jl Kesehatan no 1, Sekip, Yogyakarta, 55284, Indonesia; +62 274 588688; mhrec_fmugm@ugm.ac.id), ref: KE/EK/1904/EC/2023 |
| Health condition(s) or problem(s) studied | Residents of anesthesiology and intensive care department |
| Intervention | Current interventions as of 07/05/2024: The study will use a single-blind randomization controlled trial design to investigate the improvement of skill and knowledge of anesthesiology and intensive care residents after using the mobile application M-eDU PAIN and augmented reality in lumbar facet joint intervention. All participants will be given informed consent before joining the research and randomization to get details of the learning methods and the intervention. The randomization will be done with computerized permutation block randomization. Instructors and examiners will be blinded to the learning methods assigned to each participant. There are two groups in this study. The intervention group is anesthesiology and intensive care residents who will be given digital learning methods which is access to download and use the M-eDU PAIN mobile application to get courses on pain intervention and management in 2 weeks. The control group is anesthesia and intensive care residents who will be given traditional learning methods by getting pain intervention and management lectures in class (face-to-face) two times from experts. After 2 weeks of courses, both groups will be given a simulation class, and the instructor will explain how to do selected pain interventions using phantoms that have been validated. Both groups will do a pre-test before the course and a post-test after the course to measure the improvement of knowledge. OSCE will be done to measure residents’ skills after taking the courses and simulation classes. The total duration of the intervention is 5 weeks. _____ Previous interventions: The study will use a single-blind randomization controlled trial design to investigate the improvement of skill and knowledge of anesthesia residents after using the mobile application M-eDU PAIN and augmented reality in lumbar facet joint intervention. All participants will be given informed consent before joining the research and randomization to get details of the learning methods and the intervention. The randomization will be done with computerized permutation block randomization. Instructors and examiners will be blinded to the learning methods assigned to each participant. There are two groups in this study. The intervention group is anesthesiology residents who will be given digital learning methods which is access to download and use the M-eDU PAIN mobile application to get courses on pain intervention and management in 2 weeks. The control group is anesthesiology residents who will be given traditional learning methods by getting pain intervention and management lectures in class (face-to-face) two times from experts. After 2 weeks of courses, both groups will be given a simulation class, and the instructor will explain how to do selected pain interventions using phantoms that have been validated. Both groups will do a pre-test before the course and a post-test after the course to measure the improvement of knowledge. OSCE will be done to measure residents’ skills after taking the courses and simulation classes. The total duration of the intervention is 5 weeks. |
| Intervention type | Other |
| Primary outcome measure | Skills measured using Objective Structured Clinical Examination (OSCE), participants will be examined by given cases and asked to do a simulation of pain intervention or management. The examiner will have a checklist for OSCE scoring (the checklist was made by the investigator and validated by the anesthesiologist and pain management expert). Participants will be given 20 minutes for each case/station. |
| Secondary outcome measures | Knowledge measured using questions formulated by the investigators and validated by an anesthesiologist or pain management specialist/expert. The pre-test will be done before all participants are exposed to the learning method (lecture or application). The post-test will be given after all participants finish all the courses. |
| Overall study start date | 06/11/2023 |
| Completion date | 07/04/2024 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 82 |
| Total final enrolment | 110 |
| Key inclusion criteria | Current inclusion criteria as of 07/05/2024: 1. Resident of anesthesiology and intensive care department that had passed pain module 2. Willing to take part in research by signing informed consent _____ Previous inclusion criteria: 1. Resident of anesthesia that had passed pain module 2. Willing to take part in research by signing informed consent |
| Key exclusion criteria | 1. Has previously done intervention for lumbar facet joint pain using fluoroscopic guidance 2. Can't speak Indonesian |
| Date of first enrolment | 05/02/2024 |
| Date of final enrolment | 11/02/2024 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Yogyakarta
55284
Indonesia
Sponsor information
University/education
Bulaksumur, Caturtunggal, Depok
Yogyakarta
55284
Indonesia
| Phone | +62-274514495 |
|---|---|
| anestesi.fkkmk@ugm.ac.id | |
| Website | http://www.ugm.ac.id/ |
"ROR" |
https://ror.org/03ke6d638 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from the Department of Anesthesiology and Intensive Care, Faculty of Medicine, Nursing, and Public Health, Universitas Gadjah Mada. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 30/01/2024 | No | Yes |
Additional files
Editorial Notes
07/05/2024: The following changes were made to the trial record:
1. The overall start date was changed from 05/12/2023 to 06/11/2023.
2. The condition was changed from "Residents of anesthesia department" to "Residents of anesthesiology and intensive care department".
3. The interventions were changed.
4. The inclusion criteria were changed.
5. The total final enrolment was added.
6. The plain English summary was updated to reflect these changes.
08/03/2024: Contact details updated.
30/01/2024: Study's existence confirmed by the Medical and Health Research Ethics Committee of Universitas Gadjah Mada.
