HandNCT06572176
Investigation of Fluorescent Concretization Intervention on Intensive Care Nurses' Hand Hygiene Training
A study testing With fluorescent concretization group in people with Hand and Health Care Associated Infection, run by Uludag University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Health Care Associated Infection, Training Group, Sensitivity
- What is being tested?
- With fluorescent concretization group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2021to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University Health Sciences Faculty of the Nursing Department
Nilufer, Bursa, 16059
About this study
Official title: 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).
Read the 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).
- Being tested
- With fluorescent concretization group
- Keywords
- health care associated infections, fluorescent, hygiene, intensive care units
- Medical subject headings
- Cross Infection, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With fluorescent concretization groupBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average 1 year
Secondary outcomes (1)
Hand Hygiene Information Form (HHIF)
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.
Measured: through study completion, an average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start17 Jul 2021
- Primary completion15 Nov 2021
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized controlled pretest-posttest and follow-up research design were used.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hulya Yilmaz, Uludag University
- Investigators
- Hülya YILMAZ, Phd, Msc, Principal investigator, Bursa Uludag University, Faculty of Health SciencesDilan Ayhan, Msc, Study chair, Health Research and Application Center, Faculty of Medicine, Bursa Uludag UniversityDilek YILMAZ, Phd, Msc, Study chair, Bursa Uludag University, Faculty of Health SciencesYılmaz Özen, Professor, Study chair, Health Research and Application Center, Faculty of Medicine, Bursa Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572176
- Sponsor's protocol ID
- 2021-7/18
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 34246184Cambil-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.
PubMed 32490263Diefenbacher 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.
PubMed 30738912Du 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.
PubMed 33537803Yilmaz 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.
PubMed 40814898
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Fluorescent Concretization Intervention on Intensive Care Nurses' Hand Hygiene Training According to the Kirkpatrick Model: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06572176
- Acronym / sponsor ID
- 2021-7/18
- Keywords
- health care associated infections, fluorescent, hygiene, intensive care units
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster-randomized controlled pretest-posttest and follow-up research design were used.
| Arm | Type | Receives |
|---|---|---|
| Experimental: With fluorescent concretization group | Experimental | Behavioral: With fluorescent concretization groupNurses 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. |
| Control: Without fluorescent concretization group | No intervention | –The same interventions were repeated without fluorescent concretization and UV-A light intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| With fluorescent concretization groupAlso: fluorescent concretization groupNurses 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. | Behavioural | Experimental: With fluorescent concretization group |
Primary outcome
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.
1 secondary outcome
Hand Hygiene Information Form (HHIF)
Time frame: through study completion, an average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 34246184Bounou 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.
- Background: PubMed 32490263Cambil-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.
- Background: PubMed 30738912Diefenbacher 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.
- Background: PubMed 33537803Du 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.
- Derived from this study: PubMed 40814898Yilmaz 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hülya YILMAZ, Phd, Msc principal investigator
Bursa Uludag University, Faculty of Health Sciences
Dilan Ayhan, Msc study chair
Health Research and Application Center, Faculty of Medicine, Bursa Uludag University
Dilek YILMAZ, Phd, Msc study chair
Bursa Uludag University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With fluorescent concretization group in people with Hand and Health Care Associated Infection, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Washing Skill Efficacy (HWSE) (time frame: through study completion, an average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572176, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.