NCT07160842

Brief Summary

Background Hand hygiene refers to the practice of keeping hands clean to prevent the spread of disease. Hand hygiene workshops are an important tool to educate students about the importance of keeping their hands clean and healthy. Objectives The primary objective of this project is to evaluate the effectiveness of an educational intervention previously used in other settings that incorporates a fluorescence-based device to quantify the quality of hand hygiene in real time, together with a training workshop for students, with the aim of improving health promotion and prevention in the short and medium term (1, 3, and 6 months). Methods This is a sub-study of the Sentinel Schools Project. It is a controlled before-after study with school level allocation using a single matched pair (1 intervention school; 1 control school) and repeated measures conducted in schools belonging to the Sentinel Schools network within the Camp de Tarragona health region. The study population comprises students enrolled in primary education at these schools. The project field team carried out a pre-intervention assessment of handwashing quality in both study arms using a device that uses fluorescence to detect adequately washed areas of the hand. In the intervention arm, an educational training session on hand hygiene was delivered, followed by post-intervention assessments at short and medium term in both study arms. To examine the acceptability of the intervention, an ad hoc questionnaire was administered to the teachers who supervise the participating classes and also focal groups and enterprises were made to access the acceptability of the intervention. Statistical Analysis Frequencies and percentages will be calculated for qualitative variables; for quantitative variables, the mean and standard deviation, as well as minimum and maximum values, will be reported. Ninety-five percent confidence intervals will be presented for means and for proportions. Bivariate analyses for quantitative variables will be performed, estimating Pearson correlation coefficients and/or linear regression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 29, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

hand hygieneprevention

Outcome Measures

Primary Outcomes (1)

  • Percentage of hand surface area correctly washed

    The percentage of clean hand surface area, defined as the proportion of the total hand that was adequately covered with hand rub

    From enrollment to the end of the evaluation visits at 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback

Behavioral: Hand hygiene intervention

Control group

NO INTERVENTION

The control group received the hand hygiene evaluation visits without the educational session

Interventions

The educational intervention consisted of a two-part training session: (i) a thirty-minute didactic session introducing the 7-step alcohol-based hand rub (ABHR) technique (14), the importance of proper hand hygiene for infection prevention; and (ii) a practical component on hand hygiene with real-time feedback.

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students attending third- to sixth-grade of enrolled primary school

You may not qualify if:

  • physical or intellectual disabilities precluding correct hand hygiene
  • allergy/contraindication to alcohol-based hand rub (ABHR)
  • \<80% school attendance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cap Sant Pere

Reus, 43202, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Pharmacology

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start

March 2, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

No individual participant data (IPD) will be shared. This trial was conducted in schools with minors, and informed consent did not include permission to share de-identified IPD beyond the study team. In alignment with ethical approvals and applicable data protection regulations, only aggregate results will be made publicly available.

Locations