DOI: 10.5061/dryad.4xgxd25kw
title: Dataset on the pain-relieving effect of local cooling during vaccine injections in preschool children

description: 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.
description: 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.
description: # 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.