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NCT04096833
Virtual Reality for the Treatment of Pain in Pediatric Vaccination
NA trial testing Virtual Reality Group in Virtual Reality in 162 participants. Completed in 1 June 2023.
1 June 2023
Quick facts
| Lead sponsor | Cardenal Herrera University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 162 |
| Start date | 1 March 2021 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Virtual Reality Group
Conditions studied
- Virtual Reality — all drugs for Virtual Reality →
- Vaccination — all drugs for Vaccination →
- Pain — all drugs for Pain →
- Nursing — all drugs for Nursing →
Sponsor
Cardenal Herrera University
Who can join
Adults 3 to 14, any sex, with Virtual Reality or Vaccination. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective: to estimate the effect of virtual reality as a distracting technique against traditional distracting techniques in the vaccination procedure in the pediatric population. Design: randomized clinical trial. Field of study: the study will be carried out in the field of pediatric primary care nursing consultation, where the pediatric systematic vaccination is performed. Subjects to study: the sample will be made up of children from 3 to 14 years old who are punctured for immunization in the Fuensanta Health Center that belongs to the Department of Health Valencia-General Hospital. Variables: age, sex, family country of origin, years living in Spain, number of children of the nuclear family, order in the number of siblings, socioeconomic level, age of the caregiver that accompanies the child, affiliation / bond with the child . Group to which the subject belongs (intervention group vs. control group). Number of punctures received in the last year. Heart rate pre and post vaccination. Type of vaccine. Combination of several punctures in the query. Previous use of virtual reality. Level of pain and fear after puncture. Parent or legal guardian satisfaction. Data collection: it will be held at the Health Center on the same day as the vaccination prodecure. On the part of the nurse (heart rate, type of vaccine, combination of several punctures), the child (pain, fear) and the parents / legal guardian (satisfaction, sociodemographic). Data analysis: The descriptive analysis of the quantitative variables will be carried out through the calculation of means, typical deviations, medians, ranges, minimum and maximum values. Qualitative variables will be analyzed in absolute and relative frequencies. For the statistical inference analysis, the T-test analysis of mean difference or U-Mann Whitney (according to normal compliance) will be used. All analyzes will be performed with a 95% confidence interval.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Trials testing the same drug.
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Other recruiting trials for Virtual Reality
Currently open trials in the same condition.
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Other Cardenal Herrera University trials
Trials by the same sponsor.
- NCT07471269 — Online Pain Neuroscience Education For Fear Of Childbirth. · NA · recruiting
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- NCT07499856 — Intradialytic Exercise Program Supported by Audiovisual Media Combined With Mindfulness · NA · enrolling by invitation
- NCT07275112 — Cross-cultural an Reliability and Validity Evaluation of TENDINS-A in Spain · completed
- NCT07133581 — Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04096833 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cardenal Herrera University
- Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04096833.
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