NCT06572176

Brief Summary

Aim: The primary objective was to assess the effect of fluorescent concretization intervention on intensive care nurses' hand-washing efficiency, skill performance, and duration scores during the training process. A secondary objective was to investigate the intensive care nurses to determine their level of hand hygiene knowledge before and after the training. Design: Cluster-randomised controlled pretest-posttest and follow-up research design was used. Methods: This study was conducted at a tertiary hospital in XX province, Türkiye. Seventy-six nurses from intensive care units participated in hand hygiene training. In addition to routine hand hygiene training, the participants in the intervention group (n=39) had their hand washing efficiency evaluated using ultraviolet A light. The dirty spots were shown to the participants, and the reasons were discussed. The participants in the control group (n=37) received hand washing training without fluorescent concretization and ultraviolet light intervention. The Hand Hygiene theoretical information is an evidence-based workplace intervention delivered by trained facilitators across two training. Hand Hygiene Information Forms were administered upon registration and before randomisation of all participants immediately after the final training. Two independent researchers observed Hand Washing Skill Checklist and Efficacy forms in three follow-ups (before training, 15 days after training, and four months after training).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 21, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

health care associated infectionsfluorescenthygieneintensive care units

Outcome Measures

Primary Outcomes (1)

  • Hand Washing Skill Efficacy (HWSE)

    The hands were examined in seven areas: the palm, the back of the hand, and between the fingers, specifically the thumb, fingertips, nails, the anterior side of the wrist, and the posterior side. Under the UV light, dirty spots were marked separately for the right and left hands. The dirty spot was calculated as 1 point, and the clean spot was calculated as 0 points. 0-3-point range was considered clean; 4-7 point range was considered dirty (Škodová et al., 2015). ICC coefficient was 0.98 for the right HWSE before training, 1.0 after 15 days, and 1.0 at four months after training. The ICC coefficient was 0.96 for the left HWSE before training, 1.0 at 15 days after training, and 1.0 at four months after training. Two independent researchers completed this form in three repeated follow-ups.

    through study completion, an average 1 year

Secondary Outcomes (1)

  • Hand Hygiene Information Form (HHIF)

    through study completion, an average 1 year

Study Arms (2)

Experimental: With fluorescent concretization group

EXPERIMENTAL

Nurses were given the fluorescent lotion and asked to apply it all over their hands. The CE-certified test lotion is in gel form and is safety-approved. The lotion disperses particles the same size as bacteria on the skin. These particles settle on the skin, similar to the behavior of microorganisms, but disappear with hand washing under the influence of fluorescent light. They were then asked to wash their hands with 4 ml of soap. Two researchers marked the hand washing steps independently using the "Hand Washing Skill Checklist." The duration of hand washing was recorded with a mobile stopwatch for each participant. Hand washing efficiency was evaluated using the "Derma Litecheck" device. UV rays were used after using the test lotion and drying the hands. Since any fluorescent material left on the hands would shine under UV light, it was possible to judge how well the hands were cleansed. The dirty spots were shown to the participants, and the reason for this was discussed.

Behavioral: With fluorescent concretization group

Control: Without fluorescent concretization group

NO INTERVENTION

The same interventions were repeated without fluorescent concretization and UV-A light intervention.

Interventions

Nurses were given the fluorescent lotion and asked to apply it all over their hands. The CE-certified test lotion is in gel form and is safety-approved. The lotion disperses particles the same size as bacteria on the skin. These particles settle on the skin, similar to the behavior of microorganisms, but disappear with hand washing under the influence of fluorescent light. They were then asked to wash their hands with 4 ml of soap. Two researchers marked the hand washing steps independently using the "Hand Washing Skill Checklist." The duration of hand washing was recorded with a mobile stopwatch for each participant. Hand washing efficiency was evaluated using the "Derma Litecheck" device. UV rays were used after using the test lotion and drying the hands. Since any fluorescent material left on the hands would shine under UV light, it was possible to judge how well the hands were cleansed. The dirty spots were shown to the participants, and the reason for this was discussed.

Also known as: fluorescent concretization group
Experimental: With fluorescent concretization group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nurses who have not received previous training on UVA-supported hand hygiene devices
  • nurses who have not visibly damaged skin integrity on the hands
  • Nurses are willing to participate in the study and take primary responsibility for patient care.
  • nurses who have six months or more of intensive care experience

You may not qualify if:

  • nurses who have received previous training on UVA-supported hand hygiene devices.
  • nurses who do not have visibly damaged skin integrity on the hands.
  • Nurses are willing to participate in the study and take primary responsibility for patient care.
  • nurses who have six months or less of intensive care experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University Health Sciences Faculty of the Nursing Department

Nilufer, Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (5)

  • Bounou L, Katelani S, Panagiotopoulou KI, Skouloudaki AI, Spyrou V, Orfanos P, Lagiou P. Hand hygiene education of Greek medical and nursing students: A cross-sectional study. Nurse Educ Pract. 2021 Jul;54:103130. doi: 10.1016/j.nepr.2021.103130. Epub 2021 Jun 28.

    PMID: 34246184BACKGROUND
  • Cambil-Martin J, Fernandez-Prada M, Gonzalez-Cabrera J, Rodriguez-Lopez C, Almaraz-Gomez A, Lana-Perez A, Bueno-Cavanillas A. Comparison of knowledge, attitudes and hand hygiene behavioral intention in medical and nursing students. J Prev Med Hyg. 2020 Apr 2;61(1):E9-E14. doi: 10.15167/2421-4248/jpmh2020.61.1.741. eCollection 2020 Mar.

    PMID: 32490263BACKGROUND
  • Diefenbacher S, Fliss PM, Tatzel J, Wenk J, Keller J. A quasi-randomized controlled before-after study using performance feedback and goal setting as elements of hand hygiene promotion. J Hosp Infect. 2019 Apr;101(4):399-407. doi: 10.1016/j.jhin.2019.02.001. Epub 2019 Feb 8.

    PMID: 30738912BACKGROUND
  • Du Q, Zhang D, Hu W, Li X, Xia Q, Wen T, Jia H. Nosocomial infection of COVID-19: A new challenge for healthcare professionals (Review). Int J Mol Med. 2021 Apr;47(4):31. doi: 10.3892/ijmm.2021.4864. Epub 2021 Feb 4.

    PMID: 33537803BACKGROUND
  • Yilmaz H, Ayhan D, Yilmaz D, Ozen Y. Investigation of Fluorescent Concretisation Intervention on Intensive Care Nurses' Hand Hygiene Training According to the Kirkpatrick Model: A Cluster Randomised Controlled Study. Nurs Crit Care. 2025 Sep;30(5):e70141. doi: 10.1111/nicc.70141.

MeSH Terms

Conditions

Cross InfectionHypersensitivity

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • Hülya YILMAZ, Phd, Msc

    Bursa Uludag University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Dilan Ayhan, Msc

    Health Research and Application Center, Faculty of Medicine, Bursa Uludag University

    STUDY CHAIR
  • Dilek YILMAZ, Phd, Msc

    Bursa Uludag University, Faculty of Health Sciences

    STUDY CHAIR
  • Yılmaz Özen, Professor

    Health Research and Application Center, Faculty of Medicine, Bursa Uludag University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because of the nature of the device and the procedure of fluorescent, blinding couldn't be performed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A cluster-randomized controlled pretest-posttest and follow-up research design were used.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 27, 2024

Study Start

July 17, 2021

Primary Completion

November 15, 2021

Study Completion

October 10, 2022

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Concept: H.Y., D.A., D.Y., Y.Ö. Design: H.Y., D.A., D.Y., Y.Ö. Supervision: H.Y., D.A., D.Y., Y.Ö. Materials: H.Y., D.A., D.Y., Y.Ö. Data Collection and/or Processing: H.Y., D.A. Analysis and/or Interpretation: Statistician. Literature Search: H.Y., D.A., D.Y., Y.Ö. Writing: H.Y. Critical Reviews: D.A., D.Y.

Locations