Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06357585 |
Other study ID # |
SBUBURCUCALIK |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 24, 2021 |
Est. completion date |
March 24, 2024 |
Study information
Verified date |
April 2024 |
Source |
Saglik Bilimleri Universitesi |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Following and implementing innovations and current developments in care practices for
children diagnosed with leukemia and their parents will allow the quality of care to
increase. The purpose of this research is to evaluate the effect of web-based education given
to parents of children diagnosed with leukemia on their knowledge level, satisfaction and
self-efficacy.
The research is a single-blind randomized controlled experimental research type. The research
will be conducted in a single center, Ankara Bilkent City Hospital MH4 Children's Hospital
Hematology-Oncology Clinics and Leukemia Polyclinic. The population of the research consists
of parents of children diagnosed with leukemia between the ages of 2-18 who are followed and
treated in the specified places. The sample of the research consists of 72 participants, 36
in the experimental group (the group that received web-supported training) and 36 in the
control group (the group that continued routine treatment).
The consent of the parents who meet the research criteria and voluntarily agree to
participate in the study will be obtained with the "Informed Voluntary Consent Form" and the
parents in both the experimental group and the control group will be given the "Child and
Parent Introductory Information Form", "Child with Leukemia Parent Information Level Pre-Test
Evaluation Form". ", "Generalized Perceived Self-Efficacy Scale" will be applied. Once the
sufficient number is reached, web-based training will be provided to the parents in the
experimental group. "Parents of Children with Leukemia Knowledge Level Post-Test Evaluation
Form", "Generalized Perceived Self-Efficacy Scale" and "Web-Based Parents of Children with
Leukemia Training Satisfaction Evaluation Form" will be applied to the parents who complete
the training. No intervention will be made to the parents in the control group, and the
children will continue their routine care and treatment process. The "Child with Leukemia
Parent Knowledge Level Posttest Evaluation Form" and the "Generalized Perceived Self-Efficacy
Scale" will also be applied to the parents in the control group.
Description:
Leukemia is one of the most common types of cancer among pediatric cancers. A diagnosis of
leukemia affects both children, parents and all individuals who interact with the child, and
can cause physical, social, spiritual and economic problems.
In childhood cancers, parent education is one of the important nursing practices that must be
carried out so that parents can feel competent in care practices and the child can be given
the most appropriate care in line with their needs. The content of these trainings should
focus on parents gaining skills by participating in care. It is important to provide quality
education to parents with methods that suit their learning preferences and styles. As the use
of technology has gained importance around the world, technology-based interventions for
children and parents have also become important. Developments in the field of digital health
can make it easier to transfer many aspects of cancer treatment into families' lifestyles
with new options. Technology-based interventions contribute to children and parents as they
provide opportunities such as appealing to different senses and providing continuous access
to information. One of these interventions is the creation of web-based programs. Carrying
out training via web bases provides the opportunity to easily access training content without
any time or space limitation. It also allows the individual to determine his own learning
pace and examine the materials easily.
Patients and their relatives often use the internet to access cancer-related information.
However, some of the information on the internet, which is an easy and fast way to access
information, may be outdated or inaccurate. Although the use of the internet as an
alternative method of accessing information and the fact that it is a fast and easy method of
accessing information is seen as a great advantage in terms of health services, inaccurate
and outdated information on the website poses a major problem. Therefore, it is important to
create websites where parents can access accurate and up-to-date information.Following and
implementing innovations and current developments in care practices for children diagnosed
with leukemia and their parents will allow to increase the quality of care. The purpose of
this research is to evaluate the effect of web-based education given to parents of children
diagnosed with leukemia on their knowledge level, satisfaction and self-efficacy.
The hypotheses of the research are presented below; HOa: There is no difference between the
knowledge levels of parents who received web-based child care training with a diagnosis of
leukemia and the knowledge levels of parents who did not receive training.
HOb: There is no difference between the self-efficacy scale scores of parents who received
web-based leukemia child care training and the self-efficacy scale scores of parents who did
not receive training.
H1a: There is a difference between the knowledge levels of parents who received web-based
child care training with a diagnosis of leukemia and the knowledge levels of parents who did
not receive training.
H1b: There is a difference between the self-efficacy scale scores of parents who received
web-based leukemia child care training and the self-efficacy scale scores of parents who did
not receive training.
The research is a single-blind randomized controlled experimental research type, and
"pretest-posttest randomized control group design", one of the experimental research types,
will be used in the research. The research will be conducted in a single center, Ankara
Bilkent City Hospital MH4 Children's Hospital Hematology-Oncology Clinics and Leukemia
Polyclinic. The population of the research consists of parents of children diagnosed with
leukemia between the ages of 2-18 who are followed and treated in the specified places.
"Simple random sampling method" will be used in sample selection. Before starting the
research, the sample size was determined with the Power and Sample size analysis G Power
Program. Medium effect size f = 0.25, Type I error: 0.05, Type II error: 80% (power), and the
number of samples calculated was 17 parents for the group receiving web-supported education
(experimental group), 17 parents for the group receiving routine care. For the group (control
group), 17 parents were determined as a total of 34 parents. However, it was planned to
conduct the research with a total of 60 parents, 30 parents for both groups, in order to
avoid problems in population generalization, to fulfill the parametric test assumptions of
the research, and to reveal the relationships between variables more clearly. Considering
that there may be losses due to the research requiring long-term follow-up, 72 parents will
be included in the research by taking 20% more than the determined sample number. In the
randomization to be carried out, the "simple randomization method" will be used in order to
provide equal samples for both groups (experiment-control).
In order to collect data in the research, "Child and Parent Introductory Information Form",
"Child with Leukemia Parent Information Level Pre-Test-Post-Test Evaluation Form", "Web-Based
Child with Leukemia Parent Education Satisfaction Evaluation Form", "Generalized Perceived
Self-Efficacy Scale" will be used. The consent of the parents who meet the research criteria
and voluntarily agree to participate in the study will be obtained with the "Informed
Voluntary Consent Form" and the parents in both the experimental group and the control group
will be given the "Child and Parent Introductory Information Form", "Child with Leukemia
Parent Information Level Pre-Test Evaluation Form". ", "Generalized Perceived Self-Efficacy
Scale" will be applied. Parents who meet the research criteria and voluntarily agree to
participate in the study will be included in the experimental and/or control group according
to the randomization list. Once the sufficient number is reached, the parents in the
experimental group will be contacted via mobile phone and necessary explanations (name of the
site, membership to the site, how to log in to the site, menus on the site and how to use
these menus, link of the site, training duration) will be made. In order for users to learn
according to their own learning levels, without space and time constraints, 5 modules
prepared in line with the objectives and achievements, 5 video lectures related to the
modules, and videos showing the applications in the video lectures will be uploaded to the
site. Before the modules are uploaded to the website, expert opinion will be obtained and
necessary arrangements will be made. Training achievements and objectives will be given in
the introduction part of the modules, and brief information on the subject will be given at
the beginning of the video.
Users will be asked to review the relevant modules and videos, and after reviewing the
modules, they will be asked to tick the "I have read and understood" box. Parents in the
experimental group will be given web-based training for 5 weeks. "Parents of Children with
Leukemia Knowledge Level Post-Test Evaluation Form", "Generalized Perceived Self-Efficacy
Scale" and "Web-Based Parents of Children with Leukemia Training Satisfaction Evaluation
Form" will be applied to the parents who complete the training. No intervention will be made
to the parents in the control group, and the children will continue their routine care and
treatment process. At the end of 5 weeks, "Child with Leukemia Parent Knowledge Level
Posttest Evaluation Form" and "Generalized Perceived Self-Efficacy Scale" will also be
applied to the parents in the control group. At the end of the study, the modules will be
shared with the control group.
To conduct the research, the necessary written permissions were obtained from the Ankara
Provincial Health Directorate with the permission of the ethics committee.