DOI: 10.5281/zenodo.17338176
title: Home-based virtual reality scenic relaxation for patients with insomnia and anxiety: a single-arm feasibility and safety study: de-identified datasets (v1.0)

description: De-identified participant-level data from a single-arm feasibility and safety study of a 4-week, home-based virtual reality (VR) scenic relaxation intervention for adults with chronic insomnia and co-occurring anxiety symptoms. Datasets include pre/post clinical scales (GAD-7, PHQ-9, PSQI), PSQI component scores (C1–C7), a post-intervention VR experience survey, and baseline characteristics. A complete codebook and README are provided to support reuse and replication of the manuscript’s results (including component-level PSQI summaries). Study design: single-arm (N=11 enrolled; N=10 completers), 4-week intervention delivered at home. Outcomes were collected at baseline and week 4 (post-intervention). Higher scores indicate worse symptoms for all clinical scales.

Files





S1 Dataset — prepost_dataset.csvBaseline and post-intervention scores by participant: GAD-7 (0–21), PHQ-9 (0–27), PSQI global (0–21).Note: Columns AE and SAE (0/1) are included for transparency of safety reporting; this study recorded no SAEs (see article).




S2 Dataset — vr_survey_dataset.csvPost-intervention VR experience survey (Likert): ease of use, immersion, content quality, comfort, willingness to use again.The comfort item (Q4) underlies the “~30% low comfort” summary reported in the manuscript.




S3 Dataset — background_dataset.csvBaseline characteristics used for Table 1 (e.g., age, sex, primary diagnosis category, medication flag). Includes a completion status field (e.g., “Complete the intervention?”).




S4 Dataset — psqi_components_dataset.csvPSQI components (C1–C7) at baseline and post (each 0–3, higher = worse):C1 subjective sleep quality; C2 sleep latency; C3 sleep duration; C4 habitual sleep efficiency; C5 sleep disturbances; C6 use of sleeping medication; C7 daytime dysfunction.Validation rule: PSQI global = sum of components at the same timepoint.




S1 Data Dictionary — S1_Data_Dictionary_4datasets.xlsxVariable names, types, allowed values/examples, and descriptions across all datasets.




README — README.txtFile inventory, encoding, cohort counts, and how key outcomes and confidence intervals are computed (“mean difference (post minus pre)” wording throughout).



File format & encoding: CSVs are UTF-8, comma-separated, with header rows. Missing values are empty cells. Participant IDs are pseudonymous and consistent across files.

Ethics & Registration





CRB approval: Juntendo University Certified Review Board (J24-007); written informed consent obtained.




Trial registration: Japan Registry of Clinical Trials (jRCT1032240289).



De-identification





No direct identifiers (names, addresses, free-text notes) or exact dates of birth; no device IDs.




Participant IDs are random and cannot be linked to clinic records by third parties.



Notes for reuse





Enrollment/completion: 11 enrolled; 10 completed the 4-week protocol. Analyses reflect completers.




PSQI components: Provided to support manuscript statements on component-level change; see psqi_components_dataset.csv.




Safety fields: AE / SAE columns (Yes/No) are included in prepost_dataset.csv for reproducibility of safety summaries (no SAEs in this study; see article).




License: CC BY 4.0 (Nishiki Yanagi)