- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06572176
Investigation of Fluorescent Concretization Intervention on Intensive Care Nurses' Hand Hygiene Training
Investigation of Fluorescent Concretization Intervention on Intensive Care Nurses' Hand Hygiene Training According to the Kirkpatrick Model: A Randomised Controlled Study
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).
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim: Nurses have a pivotal role in preventing and managing healthcare-acquired/associated infections by effective hand washing. 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bursa
-
Nilüfer, Bursa, Turkey, 16059
- Bursa Uludag University Health Sciences Faculty of the Nursing Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: With fluorescent concretization group
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.
|
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.
Other Names:
|
|
No Intervention: Control: Without fluorescent concretization group
The same interventions were repeated without fluorescent concretization and UV-A light intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Washing Skill Efficacy (HWSE)
Time Frame: through study completion, an average 1 year
|
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.
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through study completion, an average 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Hygiene Information Form (HHIF)
Time Frame: through study completion, an average 1 year
|
The form was prepared in line with the literature to determine participants' socio-demographic characteristics and knowledge of hand hygiene.
In line with the training content, the items in the information form consisted of the history of hand hygiene, transmission of microorganisms, bacterial flora, glove use, surgical hand washing and scrubbing, hand hygiene products, hand hygiene compliance, and HAIs.
The HHIF items created by the research team were presented to experts (n=10), including an assessment and measurement expert.
As a result of expert evaluations, the Content Validity Index (CVI) was calculated as 1.0.
Items with low CVI were excluded.
Then, "HHIF" and "Hand Hygiene Training Guide for Intensive Care Nurses" were finalized after the pilot application with five intensive care nurses outside the study group.
The form consisted of 19 items on HH topics.
The lowest and highest scores that can be obtained from the form were 0 and 100, respectively.
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through study completion, an average 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hülya YILMAZ, Phd, Msc, Bursa Uludag University, Faculty of Health Sciences
- Study Chair: 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-7/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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