Dataset on the pain-relieving effect of local cooling during vaccine injections in preschool children
Data files
Nov 24, 2024 version files 20.19 KB
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PONE-D-24-27274_data.xlsx
17.35 KB
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README.md
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Abstract
Background
Many evidence-based treatments exist for pain-relief during subcutaneous vaccine injection in children. However, these methods are commonly labor-intensive and not routinely applied in clinical settings.
Objectives
To evaluate the pain-relieving effect and safety of local cooling during subcutaneous vaccine injection in young children.
README: README for Vaccine Injection Pain-Relief Study Dataset
1. Dataset Summary
- Study Title: Evaluation of Local Cooling for Pain Relief During Subcutaneous Vaccine Injection in Preschool Children
- Purpose: This dataset was collected to assess the pain-relieving effect and safety of local cooling applied before subcutaneous vaccine injections in preschool children.
- Study Design: Single-blind, randomized, parallel-group multicenter study conducted at two pediatric clinics in Hyogo Prefecture, Japan, involving children aged 3'966 years receiving vaccinations for Japanese encephalitis or influenza.
- Primary Endpoint: Pain response during injection, evaluated through the FLACC scale based on third-party and guardian ratings.
2. File Structure and Contents
- File Format: Excel (.xlsx) spreadsheet with rows representing individual study participants and columns for each data attribute.
- Columns in the Dataset:
- ID: Unique identifier for each participant.
- Age: Age of the participant in years.
- Sex: Sex of the participant (M = male, F = female).
- Guardian: Person accompanying the participant.
- Vaccine: Type of vaccine administered (JP = Japanese encephalitis, Flu = Influenza).
- Clinic: Clinic where vaccination was administered (W = Washio Child Clinic, O = Okafuji Pediatric Clinic).
- Allocation: Intervention assignment (cooled group or non-cooled group).
- FLACC Scale Ratings (Third Party): Pain assessment scores by a third-party evaluator for Face, Leg, Activity, and Consolability, and a total score.
- FLACC Scale Ratings (Guardian): Pain assessment scores by the guardian for Face, Leg, Activity, and Consolability, and a total score.
3. Usage Notes
- Reusability: The data can be reused to evaluate pain responses to different interventions during vaccinations in pediatric patients and explore potential relationships between patient demographics and pain responses.
- Interpretation of Scores: Higher FLACC scores indicate higher levels of observed pain, while lower scores indicate lower pain levels. The third-party and guardian assessments may show variability based on the perspective of the rater.
4. Related Resources
- Study Protocol: If available, provide a link or reference to the study protocol published in a journal or repository.
5. Acknowledgments and Limitations
- Limitations: Scores may reflect subjective variations in observer ratings (third-party vs. guardian). Environmental or psychological factors influencing pain perception may not be fully controlled.
- Ethics: This study followed ethical guidelines, and consent was obtained from participants' 92 guardians. Ensure any re-analysis considers ethical implications of working with pediatric pain data.
Methods
This was a single-blind, randomized, parallel-group multicenter study conducted at two pediatric clinics in Hyogo Prefecture, which included preschool children aged 3–6 years scheduled for vaccination against Japanese encephalitis or influenza virus. Participants were randomly assigned to either the cooled group (local cooling applied using a cooling pack before vaccination) or the non-cooled group (provided with a room temperature cooling pack). Randomization was performed using a computer-generated block method. The primary endpoint was infant pain, measured using the FLACC scale (Facial expression, Leg movement, Activity, Crying, Consolability), rated by a third party reviewing videos of the vaccination process.