- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05815979
Virtual Reality Training in Nasogastric Catheter Application for Nursing Students
Evaluation of the Effect of Virtual Reality-Based Nasogastric Catheter Application Skill on the Knowledge, Skills, Self-Confidence, Anxiety and Motivation of Graduating Nursing Students
Nasogastric catheter insertion is a complex psychomotor nursing skill in which incorrect placement can cause serious harm, including pulmonary aspiration, pneumothorax and death. Nurses are professionally responsible for the procedure from their first day in clinical practice, so competence must be acquired before graduation.
The final-year students eligible for this trial had an unusual educational history. They took the Fundamentals of Nursing course, in which nasogastric catheter application is first taught, in the spring semester of 2019-2020. Face-to-face teaching was suspended in March 2020 because of the COVID-19 pandemic and the course was completed online, so the cohort received no hands-on laboratory training in that course. Clinical practice was further disrupted by the Kahramanmaras earthquakes of February 2023. Opportunities for repeated individual practice of this skill therefore remained limited throughout their education.
This single-centre, pretest-posttest randomised controlled trial compared immersive virtual reality training with traditional simulator-based practice in nasogastric catheter application. Eighty-five final-year nursing students at Eskisehir Osmangazi University were randomised to a virtual reality group or a traditional method group, and 78 completed the study. Both groups received the same theoretical and demonstration training; they then practised the procedure either in an immersive virtual reality application or on a medium-fidelity simulator, up to three times each.
The outcomes assessed were psychomotor skill performance, performance on safety-critical procedural steps, knowledge, self-confidence, anxiety and motivation. Data collection took place between 14 March and 20 May 2024.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
BACKGROUND
Serious complications of incorrect nasogastric catheter placement include pulmonary aspiration, pneumothorax, abscess, haemothorax, bronchopleural fistula and perforation, and such complications can be fatal. Under the Turkish Nursing Regulation, assessment of patients' nutritional needs and the application of nasogastric catheters for feeding are the responsibility of the nurse, and nasogastric catheter placement, care and removal are listed as required practical skills in the Turkish Nursing National Core Education Programme.
Previous studies of virtual reality-based nasogastric catheter training in nursing education have been conducted with first- and second-year students. No published study had examined the effect of immersive virtual reality training in final-year students who are about to enter professional practice, nor evaluated knowledge, skill, self-confidence, anxiety and motivation together within a single controlled design.
HYPOTHESES
H1: There is a significant difference in skill scores between students trained by the traditional method and those trained by the virtual reality method.
H2: There is a significant difference in critical procedural step scores between the two groups.
H3: There is a significant difference in knowledge scores between the two groups.
H4: There is a significant difference in self-confidence scores between the two groups.
H5: There is a significant difference in anxiety scores between the two groups. H6: There is a significant difference in motivation scores between the two groups.
DESIGN AND SETTING
Single-centre, two-arm, parallel-group, pretest-posttest randomised controlled trial with 1:1 allocation, conducted in the Department of Nursing, Faculty of Health Sciences, Eskisehir Osmangazi University, Eskisehir, Turkey, during the spring semester of the 2023-2024 academic year. Group allocation is reported according to the CONSORT statement.
PARTICIPANTS AND SAMPLE SIZE
The study population comprised the 135 fourth-year nursing students enrolled in the department. Sample size was calculated with G*Power 3.1.9.4 from the mean and standard deviation of the nasogastric catheter insertion skill checklist reported in a reference study, with a two-tailed test, alpha 0.05, power 0.95 and effect size d = 0.85, giving 76 participants in total and a minimum of 38 per group. Allowing for 10% attrition, the target was raised to 84. Eighty-five eligible and consenting students were randomised.
RANDOMISATION
All stages of randomisation were carried out by an independent statistician who took no other part in the study. The 85 students were stratified by sex, grade point average, knowledge test pretest score and skill checklist pretest score, and allocated to two groups using the RAND() function in Microsoft Excel so that the groups were homogeneous. Which group served as the intervention arm was decided by blinded lottery. This produced an intervention group of 42 and a control group of 43.
BLINDING
Because of the nature of the intervention, neither the participants nor the researcher delivering the training could be masked. Masking was applied at outcome assessment and data analysis. The two independent observers who scored the skill checklist were postgraduate students in Fundamentals of Nursing who took no other part in the study and were not informed of group allocation. The statistician who analysed the data was a different person from the one who performed the randomisation and was also masked; groups were coded as 1 and 2 before data entry.
PROCEDURES
All participants first completed the informed consent form, personal information form, knowledge test and the self-confidence and anxiety visual analog scales, and were assessed on a medium-fidelity simulator using the skill checklist (pretest, 14-25 March 2024). Randomisation followed.
One week after randomisation, all participants received identical theoretical training (a 50-minute PowerPoint presentation validated by three subject experts) and demonstration training on a medium-fidelity simulator (30 minutes per group, five groups).
One week later, the two arms entered a free practice period held simultaneously to limit contamination. Participants in the virtual reality arm were instructed in the use of the headset and controllers and completed the procedure in the virtual reality application up to three times. Participants in the traditional method arm practised the procedure on a medium-fidelity simulator up to three times under researcher supervision.
At least two weeks after free practice, each participant performed nasogastric catheter insertion and removal on the medium-fidelity simulator and was scored independently by the two masked observers; performance duration was recorded. Immediately afterwards, participants completed the knowledge test, the self-confidence and anxiety visual analog scales and the motivation scale (posttest, 11-20 May 2024).
VIRTUAL REALITY APPLICATION
The application was developed in Unity 2022.3.18f1 with the XR Interaction Toolkit 2.1 for the Oculus Quest 2 platform. It comprises two modules: nasogastric catheter insertion (53 procedural steps) and removal (32 procedural steps). Each step is a separate scene set in a hospital room seen from the nurse's perspective, with all required materials within reach and a reference screen displaying the materials needed at each step. Guidance is provided by a message box displaying the current step and by synchronised audio narration. Applicability was assessed by three experts and the application was revised in line with their recommendations before use.
MEASUREMENT INSTRUMENTS
Nasogastric Catheter Application Knowledge Test: 25 multiple-choice items, score range 0-25, KR-20 = 0.82.
Nasogastric Catheter Application Checklist: 85 steps (53 insertion, 32 removal), each scored 0, 1 or 2, total range 0-170, inter-rater ICC = 0.983.
Critical Procedural Step score: 30 safety-critical items identified by an eight-member expert panel using the Lawshe technique, total range 0-60, inter-rater ICC = 0.980.
Self-Confidence and Anxiety Visual Analog Scales: 10 cm scales, range 0-10 each.
Instructional Material Motivation Scale for Single-Use: 14 items, five-point Likert format, range 14-70, Cronbach's alpha 0.91.
STATISTICAL ANALYSIS
Analyses were performed with SPSS 22.0 at a two-sided significance level of 0.05. Normality was assessed using skewness and kurtosis, coefficients of variation, detrended plots and histograms. Baseline comparability was tested with independent-samples t-tests and chi-square tests. Repeated measures across groups were compared with two-way analysis of variance with repeated measures, with the group by time interaction as the effect of primary interest; between-group comparisons used Tukey's test and effect sizes are reported as eta-squared. Motivation, measured only after the intervention, was compared with an independent-samples t-test.
SAFETY
No invasive procedure was performed on any participant. The only foreseeable risk was cybersickness from the head-mounted display. A safe working boundary was drawn in the virtual environment, the teleportation feature was used to limit motion-related discomfort, and exposure was capped at three sessions per participant. Participants were observed for discomfort and asked directly about symptoms during and after use.
ETHICS
Ethical approval was granted by the Non-Interventional Clinical Research Ethics Committee of Gaziantep Islam Science and Technology University on 21 March 2023 (Protocol no. 2023/209, Decision no. 209.23.13). Institutional permissions were obtained from the university where the study was conducted. Written informed consent was obtained from all participants. The study was conducted in accordance with the Declaration of Helsinki. After data collection ended, participants in the control arm who wished to try the virtual reality application were invited to do so.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Şahinbey/Gaziantep
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Gaziantep, Şahinbey/Gaziantep, Turkiet (Türkiye), 27100
- Gaziantep Islamic Science and Technology University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Enrolled in the fourth (final) year of the nursing programme
- Completion of all vocational courses with a clinical practice component taken up to the fourth year (Fundamentals of Nursing, Internal Medicine Nursing, Surgical Diseases Nursing, Obstetrics and Gynaecological Nursing, Child Health and Diseases Nursing)
- Aged 18 years or over
- Willing to participate voluntarily in the study
Exclusion Criteria:
- Graduated from a secondary school providing health-related vocational education
- Currently employed in a health-related post in any health institution
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Virtual Reality Group
Participants received the theoretical and demonstration training common to both arms, followed by training in the use of the virtual reality headset and controllers. During a free practice period they completed the nasogastric catheter insertion and removal procedure in an immersive virtual reality application up to three times, under researcher supervision within a defined safe boundary. |
An immersive virtual reality application developed in Unity for the Oculus Quest 2 platform, comprising two modules: nasogastric catheter insertion (53 procedural steps) and removal (32 procedural steps). Each step is a separate scene set in a hospital room seen from the nurse's perspective, with on-screen text and synchronised audio narration guiding the user through the procedure. |
|
Aktiv komparator: Traditional Method Group
Participants received the theoretical and demonstration training common to both arms, followed by a free practice period in the professional skills laboratory, held simultaneously with the virtual reality group. During this period they performed the nasogastric catheter insertion and removal procedure on a medium-fidelity simulator up to three times, under researcher supervision. |
Practice of nasogastric catheter insertion and removal on a medium-fidelity simulator in the professional skills laboratory, following demonstration by the researcher in accordance with the Nasogastric Catheter Application Checklist. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Nasogastric Catheter Application Skill Score
Tidsram: Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Psychomotor performance in nasogastric catheter insertion and removal, assessed with the Nasogastric Catheter Application Checklist developed by the researchers. The checklist contains 85 steps (53 for insertion, 32 for removal). Each step scores 2 if performed completely, 1 if performed incompletely and 0 if not performed. Total score ranges from 0 to 170. Higher scores indicate better psychomotor performance. |
Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Critical Procedural Step Score
Tidsram: Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Safety-critical subset of the Nasogastric Catheter Application Checklist. Thirty items (22 for insertion, 8 for removal) were identified as critical procedural steps by an eight-member expert panel using the Lawshe technique. Each step scores 0, 1 or 2, giving a total score from 0 to 60. Higher scores indicate safer performance of the procedure. |
Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
|
Change in Nasogastric Catheter Application Knowledge Test Score
Tidsram: Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Knowledge required for nasogastric catheter application, assessed with a 25-item multiple-choice test developed by the researchers, each item having five options. Correct answers score 1 and incorrect answers score 0, giving a total score from 0 to 25. Higher scores indicate greater knowledge. |
Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
|
Change in Anxiety Score
Tidsram: Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Situational anxiety related to performing nasogastric catheter application, assessed with a 10 cm horizontal visual analog scale anchored at 0 (no anxiety) and 10 (very high anxiety). The score is obtained by measuring the point marked by the participant. Higher scores indicate greater anxiety. |
Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
|
Change in Self-Confidence Score
Tidsram: Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
Self-confidence in performing nasogastric catheter application, assessed with a 10 cm horizontal visual analog scale anchored at 0 (no self-confidence) and 10 (very high self-confidence). The score is obtained by measuring the point marked by the participant. Higher scores indicate greater self-confidence. |
Baseline (pretest) and post-intervention (posttest), approximately 10 weeks apart
|
|
Motivation Towards the Instructional Material
Tidsram: Post-intervention (posttest) only, approximately 10 weeks after baseline
|
Motivation towards the instructional material used, assessed with the Instructional Material Motivation Scale for Single-Use. The scale is unidimensional and comprises 14 five-point Likert items with no reverse-scored items, giving a total score from 14 to 70. Higher scores indicate greater motivation. |
Post-intervention (posttest) only, approximately 10 weeks after baseline
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, Lyman B, Metheny NA, Mueller C, Robbins S, Wessel J; A.S.P.E.N. Board of Directors. Enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr. 2009 Mar-Apr;33(2):122-67. doi: 10.1177/0148607108330314. Epub 2009 Jan 26. No abstract available.
- Choi KS, He X, Chiang VC, Deng Z. A virtual reality based simulator for learning nasogastric tube placement. Comput Biol Med. 2015 Feb;57:103-15. doi: 10.1016/j.compbiomed.2014.12.006. Epub 2014 Dec 17.
- Chang YM, Lai CL. Exploring the experiences of nursing students in using immersive virtual reality to learn nursing skills. Nurse Educ Today. 2021 Feb;97:104670. doi: 10.1016/j.nedt.2020.104670. Epub 2020 Nov 17.
- Berndt J, Dinndorf-Hogenson G, Herheim R, Hoover C, Lanc N, Neuwirth J, Tollefson B. Collaborative Classroom Simulation (CCS): An Innovative Pedagogy Using Simulation in Nursing Education. Nurs Educ Perspect. 2015 Nov-Dec;36(6):401-2. doi: 10.5480/14-1420.
- Vaughn J, Lister M, Shaw RJ. Piloting Augmented Reality Technology to Enhance Realism in Clinical Simulation. Comput Inform Nurs. 2016 Sep;34(9):402-5. doi: 10.1097/CIN.0000000000000251.
- Ferguson C, Davidson PM, Scott PJ, Jackson D, Hickman LD. Augmented reality, virtual reality and gaming: an integral part of nursing. Contemp Nurse. 2015;51(1):1-4. doi: 10.1080/10376178.2015.1130360. Epub 2016 Jan 14. No abstract available.
- Chao YC, Hu SH, Chiu HY, Huang PH, Tsai HT, Chuang YH. The effects of an immersive 3d interactive video program on improving student nurses' nursing skill competence: A randomized controlled trial study. Nurse Educ Today. 2021 Aug;103:104979. doi: 10.1016/j.nedt.2021.104979. Epub 2021 May 18.
- Perry, AG. (2016). Enteral Nutrition. In: Elkin, MK., Perry, AG., Potter, PA. (Eds.) Nursing Interventions and clinical skills., Mosby Inc.,St. Louis, Missouri, 996-1036.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 21-03-2023/23
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Individual participant data are not publicly available owing to privacy and ethical restrictions. The data that support the findings of this study are available from the corresponding author on reasonable request.
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