The Effect of Hand Hygiene Education With Cognitive Behavioral Therapy on Hospital Infection Awareness: a Randomized Controlled Trial
Phase: NA
Conditions: Intervention (Training) Condition
Sponsor: Kirsehir Ahi Evran Universitesi

Official Title: 
The Effect of Hand Hygiene Education With Cognitive Behavioral Therapy on Hospital 
Infection Awareness: a Randomized Controlled Trial 
NCT Number: 
Not yet assigned (pending registration at ClinicalTrials.gov) 
 
Document Type: 
Study protocol 
 
Document Date: 
12 Aug 2025 
 
 

Overview of the Study 
 
AHIEVRAN-2025- HAND HYGIENE 
Brief title: The effect of cognitive behavioral therapy and hand hygiene education on hospital 
infection awareness 
Official Title: The effect of hand hygiene education with cognitive behavioral therapy on 
hospital infection awareness: a randomized controlled trial 
Sponsor: no  
Collaborators: no  
 
Oversight 
U.S. FDA-regulated Drug: No 
U.S. FDA-regulated Device: No 
U.S. FDA IND/IDE: No 
Human Subjects Review: Board Status: Approved 
Approval Number: 2025-13/167  
Board Name: Kırşehir Ahi Evran University Health Sciences Scientific Research Ethics 
Committee 
Board Affiliation: no  
Phone: +90 386 280 24 87  
Email: tipetikkurul@ahievran.edu.tr 
Address: Kırşehir Ahi Evran Faculty of Medicine Health Sciences Scientific Research Ethics 
Committee, Kırşehir/ Türkiye.  
Data Monitoring: No 
FDA Regulated Intervention: No 
 
 
 
 

Study Description 
Brief Summary 
The aim of this study is to investigate the effect of hand hygiene training applied using cognitive 
behavioural therapy techniques on healthcare workers' attitudes and beliefs regarding 
nosocomial infections. Another aim is to increase the effectiveness of hand hygiene training 
and to instil correct hand hygiene behaviour by utilising cognitive behavioural therapy to raise 
awareness of nosocomial infections among healthcare workers. This is a single-centre, double-
blind, randomised, controlled trial with a single parallel group. The hypothesis is that hand 
hygiene training using cognitive behavioural therapy techniques will influence healthcare 
workers' attitudes and beliefs regarding nosocomial infections.  
Detailed explanation 
Although hand hygiene is a significant factor contributing to nosocomial infections, the 
problem of failure to implement effective hand hygiene has not yet been fully resolved. Hospital 
infections are generally defined as infections that develop in a patient who has been admitted 
to hospital for reasons other than infection. If the patient is not in the incubation period when 
admitted to hospital or does not have the signs and symptoms of that infection, infections that 
occur in hospital are hospital-acquired infections. Supporting hand hygiene training with 
Cognitive Behavioural Therapy represents a relatively new approach in the literature. Like 
many health behaviour interventions developed based on Ajzen's Theory of Planned Behaviour, 
this study also aimed to achieve lasting behavioural change by targeting cognitive attitudes and 
norms. Similar interventions have been found to be effective particularly in areas such as 
diabetes management, smoking cessation, and increasing physical activity. Von Lengerke et al. 
observed hand hygiene behaviour in their randomised controlled trials. Boscart et al. also 
utilised psychological theories to promote hand hygiene behaviour. However, the number of 
studies employing a cognitive behavioural therapy-based approach specifically for hand 
hygiene is limited. In this respect, this study makes an important contribution to the literature. 
This study goes beyond classical education models and focuses on transforming healthcare 
workers' attitudes towards nosocomial infections through an education approach based on a 
cognitive behavioural foundation. Given the scarcity of hand hygiene training supported by 
CBT in the current literature, this study presents a novel theoretical approach and proposes a 
robust strategy for preventing hospital infections in practice.  
 

Communication and locations 
Ayşegül Turan 
E mail: aysegul.turan@ahievran.edu.tr 
Kırşehir Ahi Evran University, Faculty of Health Sciences, Department of Nursing 
Work address: Kırşehir Education and Research Hospital  
 
Conditions 
Hand hygiene training using cognitive behavioural therapy 
 
Intervention / Training 
Education: Hand hygiene training using cognitive behavioural therapy techniques  
 
Participation Criteria 
Inclusion criteria: 
1.      Being a healthcare worker 
2.      To have been actively working in a hospital for at least 1 year 
3.      Agreeing to participate in the research 
Exclusion criteria: 
1.     Working on the infection control committee 
2.      Refusing to participate in the research 
 
Work Plan 
Design Details 
Study Type: Interventional 
Primary Objective: Change in beliefs and attitudes  
Study Phase: N/A 
Separation: Randomise 

Interventionist Model: Parallel Assignment 
Number of Arms: 2 
Masking: Double (participant and statistician) 
Allocation: Randomized 
Enrolment: No participants yet. Power analysis was performed using the G-Power 3.1.9.4 
programme to determine the sample size for the study. According to the calculations made based 
on the independent samples t-test, the required total sample size was determined to be 128 
individuals, based on an effect size of 0.50, a margin of error (α=0.05) and 80% power. 
Considering any potential setbacks that may occur during the study, the target sample size is 
140 individuals.  
Interventionist Model Description: single-centred, parallel group 
Control and Interventions Group 
Arms and Interventions  
A double-blind technique will be used in this study. Neither the participants nor the researcher 
collecting the data will know whether the participants are in the intervention or control group. 
Healthcare professionals will be included in both the intervention and control groups. 
Experimental: Interventions Group 
The intervention group will receive hand hygiene training using cognitive behavioural therapy 
techniques. Hand hygiene training using cognitive behavioural therapy techniques will be 
delivered by a specialist psychologist certified in cognitive behavioural therapy from among 
the researchers. The training consists of three 1-hour sessions. The information on hand hygiene 
included in the training has been obtained from data provided by the Turkish Ministry of Health 
and the World Health Organisation.  
The aim of this training is to convince healthcare workers of the importance of hand hygiene in 
the prevention of hospital-acquired infections and to boost their confidence in their ability to 
adhere to hand hygiene guidelines. A strong commitment to hand hygiene will be possible 
through the development of self-regulatory behaviour. The objective is to foster self-regulatory 
behaviour through hand hygiene training integrated with Cognitive Behavioural Therapy 
techniques.  
 

No Intervention: Control Group 
The control group will receive routine in-service training provided by the hospital training unit, 
the content of which has been approved by the Ministry of Health. 
Assigned Interventions: Hand hygiene training prepared with cognitive behavioral therapy 
method. Cognitive Behavioural Therapy aims to help individuals recognise their incorrect or 
dysfunctional thoughts and develop more realistic and healthy ways of thinking in their place. 
This approach, which argues that cognitive beliefs must be transformed to change health 
behaviours, also underpins the Theory of Planned Behaviour. According to this theory, attitudes, 
subjective norms and perceived behavioural control directly influence an individual's 
behaviour. 
The objectives of the training:  
Learning the scientific principles of hand hygiene 
Recognising the seriousness of nosocomial infections 
Recognising one's own misconceptions 
Learning about the role of education in the scope of research  
 
The sample will consist of healthcare workers employed in the clinics of Kırşehir Training and 
Research Hospital. Power analysis was performed using the G-Power 3.1.9.4 programme to 
determine the sample size for the study. According to calculations based on the independent 
samples t-test, the required total sample size was determined to be 128 individuals, based on an 
effect size of 0.50, a margin of error (α=0.05) and 80% power. Randomisation will be provided 
by nQuery Adviser, version 7.0. A double-blind technique will be used in this study. In the 
double-blind technique, participants do not know whether they are in the intervention or control 
group. At the same time, the researcher evaluating the data does not know who is in the 
intervention or control group. The data for the study will be collected twice, before and after 
the training, through face-to-face questionnaires (provided in the appendix), following 
institutional and ethics committee approval. The obtained data will be loaded into the SPSS 29 
programme, and in addition to descriptive statistics, the differences between the pre-test and 
post-test averages of the intervention group and the differences in attitudes towards nosocomial 
infections according to socio-demographic characteristics will be examined using variance 
analysis. 

The investigators will administer the Nosocomial Infection Belief and Attitude Scale to the 
intervention and control groups before and after the training. The investigators will use the 
Research Randomizer application to select all participants to be included in the study. The 
investigators will number the list of healthcare workers who need to receive hand hygiene 
training in the hospital's training unit. The investigators will select 140 people using Research 
Randomizer. The investigators will renumber the 140 people The investigators have selected 
and select 70 people using Research Randomizer. The 70 people the investigators select will be 
our intervention group. The investigators researchers will not meet the healthcare workers. The 
investigators will not inform the intervention group that they are in the intervention group. The 
intervention group will receive training in the same manner as they received routine hand 
hygiene training. The hand hygiene training, prepared using Cognitive Behavioural Therapy 
techniques, will be delivered in three sessions. Each session will last approximately one hour.  
Healthcare workers at Kırşehir Training and Research Hospital receive training on hand hygiene 
twice a year. Nurses from the infection control committee conduct hand hygiene training in the 
hospital's conference room. The training content is prepared by the Turkish Ministry of Health. 
The hospital training unit groups healthcare workers to be trained, preventing them from 
receiving training in crowded environments. 
As part of this research, the investigators plan to provide hand hygiene training developed using 
Cognitive Behavioural Therapy techniques in collaboration with nurses from the education and 
infection control committee. This training will be delivered by our specialist psychologist 
researcher, who holds a Cognitive Behavioural Therapy certification. With this training, the 
investigators aim to convince healthcare workers of the importance of hand hygiene in 
preventing hospital infections and to instil confidence in their ability to maintain hand hygiene 
compliance. Strong commitment to hand hygiene will be possible through the development of 
self-regulatory behaviour. The investigators aim to develop self-regulatory behaviour through 
hand hygiene training integrated with Cognitive Behavioural Therapy techniques. 
 
 

 
Participant 
Group/Control 
Participant Group / Intervention (Education) 
Routine hand hygiene in-
service training approved 
by the Ministry of Health 
and 
provided 
by 
the 
hospital training unit  
Hand hygiene training will be delivered using Cognitive 
Behavioural Therapy techniques. The training consists of 
three 1-hour sessions. The information on hand hygiene 
included in the training has been obtained from data 
provided by the Turkish Ministry of Health and the World 
Health Organisation. The programme, which applies 
Cognitive Behavioural Therapy techniques to the content, 
has been reviewed and approved by an expert professor in 
the field.  
 
Primary Outcome Measures 
Outcome 
Measurement 
Measurement Definition 
Time Frame 
Initial 
values 
obtained 
from 
the Nosocomial 
Infection Belief 
and 
Attitude 
Scale 
The independent variables of the study are socio-
demographic variables, while the dependent 
variables consist of items from the Hospital 
Infection Belief and Attitude Scale. Isolation, hand 
hygiene, ventilator-associated pneumonia, surgical 
site infection, and invasive procedures are measured 
using a five-point Likert scale consisting of 35 items, 
which assesses healthcare workers' beliefs and 
attitudes towards hospital infections. In the scale 
assessment, a score approaching 1 indicates low 
awareness of hospital-acquired infections, whilst a 
The first 
measurement 
will be taken 
on the same 
day 
following 
the training 
provided to 
healthcare 
workers. 
 

Outcome 
Measurement 
Measurement Definition 
Time Frame 
score approaching 5 indicates high awareness of 
hospital-acquired infections. 
 
 
 
Secondary Outcome Measures 
Outcome 
Measurement 
Measurement Definition 
Time 
Frame 
Three-month 
change following 
the Nosocomial 
Infection Belief 
and Attitude 
Scale 
measurement  
Following the provision of hand hygiene training via 
Cognitive Behavioural Therapy, the Nosocomial 
Infection Belief and Attitude Scale will be 
administered again.  
 
The 
second 
assessment 
will take 
place three 
months 
after the 
training 
provided 
to 

Outcome 
Measurement 
Measurement Definition 
Time 
Frame 
healthcare 
workers.  
 
Collaborators and Researchers 
The individuals and organisations participating in this study 
Dr Ayşegül Turan, Assistant Professor 
Clinical Psychologist Furkan Turan 
Professor Dr Gökhan Gözel, Infectious Diseases and Clinical Microbiology 
The institution where the study will be conducted: Kırşehir Education and Research Hospital 
 
Work Registration Dates 
 
Terms related to this study 
Key words 
Nosocomial infection 
Hand hygiene 
Cognitive behavioural therapy 
 

Keywords provided by Ayşegül Turan  
Kırşehir Ahi Evran University 
 
References  
Ajzen, I. (1991). The theory of planned behaviour. Organizational Behaviour and Human 
Decision Processes, 50(2), 179–211. 
Ajzen I. (2011). The theory of planned behaviour: reactions and reflections. Psychology & 
health, 26(9), 1113–1127. https://doi.org/10.1080/08870446.2011.613995  
Beck, A. T. (1976). Cognitive therapy and the emotional disorders. International Universities 
Press.  
Boscart, V.M., Fernie, G.R., Lee, J.H. et al. (2012). Using psychological theory to inform 
methods to optimize the implementation of a hand hygiene intervention. Implementation Sci 
7, 77. https://doi.org/10.1186/1748-5908-7-77. 
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical 
power analysis program for the social, behavioral, and biomedical sciences. Behavior 
Research Methods, 39: 175–191. https://doi.org/10.3758/BF03193146  
Michie, S., Abraham, C., Whittington, C., McAteer, J., & Gupta, S. (2009). Effective techniques 
in healthy eating and physical activity interventions: a meta-regression. Health Psychology, 
28(6), 690. 
Organ A ve Gürbüz T. (2012). Hastanelerde Enfeksiyon Alanlarının Belirlenmesine Yönelik 
İstatistiksel Kalite Kontrol Çalışması. Pamukkale Üniversitesi Sosyal Bilimler Enstitüsü 
Dergisi Sayı 13, Sayfa 43 – 54. https://dergipark.org.tr/tr/pub/pausbed/issue/34727/383939  
Von Lengerke T, Lutze B, Krauth C, Lange K, Stahmeyer JT, Chaberny IF. (2017). Promoting 
hand hygiene compliance: PSYGIENE—a cluster-randomized controlled trial of tailored 
interventions. Dtsch Arztebl Int, 114: 29–36. DOI: 10.3238/arztebl.2017.0029.  
……………………………. 
Yeni kaynaklar 1000 karakter uzunluğunda 
Ajzen I. (2011). The theory of planned behaviour: reactions and reflections. Psychology & 
health, 26(9), 1113–1127. https://doi.org/10.1080/08870446.2011.613995 

Boscart, V.M., Fernie, G.R., Lee, J.H. et al. (2012). Using psychological theory to inform 
methods to optimize the implementation of a hand hygiene intervention. Implementation Sci 7, 
77. https://doi.org/10.1186/1748-5908-7-77. 
Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A flexible statistical 
power analysis program for the social, behavioral, and biomedical sciences. Behavior Research 
Methods, 39: 175–191. https://doi.org/10.3758/BF03193146 
Michie, S., Abraham, C., Whittington, C., McAteer, J., & Gupta, S. (2009). Effective techniques 
in healthy eating and physical activity interventions: a meta-regression. Health Psychology, 
28(6), 690. 
Von Lengerke T, Lutze B, Krauth C, Lange K, Stahmeyer JT, Chaberny IF. (2017). Promoting 
hand hygiene compliance: PSYGIENE—a cluster-randomized controlled trial of tailored 
interventions. Dtsch Arztebl Int, 114: 29–36. DOI: 10.3238/arztebl.2017.0029.