Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05263297 |
| Other study ID # |
Cognitive-Behavioral |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
August 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to investigate the effect of two different cognitive-behavioral
combined programs, including video games or kaleidoscope, on the pain, fear and anxiety
experienced by children who apply for therapeutic or diagnostic venous blood collection, and
their parents' satisfaction levels. In addition, this research aims to create a holistic
approach to child health due to the evaluation of both children and parents.
The population of the research will be children aged 8-10 who come to the Children's Blood
Collection Unit of Karaman Training and Research Hospital between February 2022 and March
2022. The sample of the study will consist of 96 children and their parents who applied to
the Blood Collection Unit on the specified dates, met the inclusion criteria and agreed to
participate in the study. The pediatric blood collection unit provides service between 08:00
and 16:00 on weekdays. In order to determine the number of samples, power analysis was
performed using the G*Power (v3.1.9) program. It was planned to carry out the research with a
total of 96 children and their parents, 32 in each group, considering possible case losses
during the research period.
Evaluation of the data will be done in the computer environment with the SPSS (Statistical
Package for Social Sciences) 22.0 package program. Percentage distributions, mean, standard
deviation, chi-square test, analysis of variance will be used in the analysis of the data. In
addition, the variance of the groups will be examined with the Levene test in order to make
further analysis. In cases where the variance is equal, Bonferroni analysis will be used in
post hoc advanced analyses, and Dunnett T3 analysis will be used in cases where the variance
is not equal. The research findings will be evaluated at the 95% confidence interval, at the
p<0.05 significance level.
Description:
Type of Research The study was planned in a randomized controlled experimental research
design to examine the effect of two different cognitive-behavioral combined programs,
including video games or kaleidoscope, on the pain, fear and anxiety experienced by children
due to venous blood collection and the satisfaction levels of their parents.
Variables of the Study Dependent variables: Children's Visual Analog Scale (VAS), Wong Baker
Faces Pain Scale (Wong-Baker Faces Pain Scale- W-BFS), Child Fear Inventory (CDS), Child
Anxiety Scale-State Scale (CAS-D), PedsQL Health Scores from the Care Parental Satisfaction
Scale.
Independent variables: Sociodemographic characteristics, video game or kaleidoscope,
including two different cognitive-behavioral combined program applications.
Hypotheses Hypothesis 1. Cognitive-behavioral combined program including video game in blood
collection has an effect on children's pain, fear and anxiety levels.
Hypothesis 2. Cognitive-behavioral combined program including kaleidoscope in blood
collection has an effect on children's pain, fear and anxiety levels.
Hypothesis 3. There is a difference in pain, fear and anxiety levels between the children who
used the cognitive-behavioral combined program including video game in blood collection and
the children who used the cognitive-behavioral combined program including kaleidoscope.
Hypothesis 4. Cognitive-behavioral combined program including video game in blood collection
has an effect on parents' satisfaction levels.
Hypothesis 5. Cognitive-behavioral combined program including kaleidoscope in blood
collection has an effect on parents' satisfaction levels.
Hypothesis 6. There is a difference in satisfaction levels between the parents of the
children who used the cognitive-behavioral combined program including video game in the blood
collection process and the parents of the children who used the cognitive-behavioral combined
program including the kaleidoscope.
In order to determine the number of samples, power analysis was performed using the G*Power
(v3.1.9) program. The power of the study is expressed as 1-β (β = probability of type II
error), and in general studies should have 80% power. Power analysis was performed to
determine the adequacy of the sample size of the study; The power of the study was determined
to be 0.95 with a significance level of 0.05, a confidence interval of 0.95, and an effect
size of 0.97. Accordingly, there must be 29 people in each group. It was planned to carry out
the research with a total of 96 children and their parents, 32 in each group, considering
possible case losses during the research period.
Randomization The process of enrolling children and parents into groups will be randomly
assigned. In the study, "stratification and block randomization methods" will be used in
assigning participants to control and intervention groups. It has been reported in the
literature that age, gender, and fear of interventional procedures are among the factors
affecting the fear and stress experienced by children in interventional procedures.
Accordingly, the children will be stratified as "girl and boy" for the gender variable,
"afraid and not afraid" for the fear of the procedure, and randomization with blocks will be
applied. The determined layers were created as codes obtained from the permutation-based
computer program. At the beginning of the research, which letter would be the intervention or
control group was determined by the closed opaque envelope method. Accordingly, the A was
used for the control group, the B for the cognitive-behavioral combined program with the
video game, and the C for the cognitive-behavioral combined program with the kaleidoscope.
These block sets will be placed in envelopes of different colors and sizes by the researcher
and kept in a black bag. It will be determined which stratum the children are in. It will be
determined which group the determined child will be in according to the block set randomly
drawn by the children from the black bag. The groups chosen by the children will be the same
as those of their parents. If the next children are in the same layer, the block set will
continue until the completion of the set. When it is determined that the incoming child is in
a different layer, a new block set will be selected from the bag and the group will be
determined.
S1 Girl, Afraid ABAA, CACB, ACBB, CABC, BACC, BACB S2 Girl, Not afraid AACB, ABAC, ABAB,
CACB, BCCC, ABBC S3 Boy, Afraid ABCC, ABCA, BCAC, ABBB, CBBC, CAAA S4 Boy, Not afraid ABAA,
CACB, ACBB, CABC, BCAB, ACCB
Venous blood collection of all children included in the study will be performed by an
experienced nurse in the pediatric blood collection unit. Thus, the application differences
that may occur during the venous blood collection process will be eliminated. It was planned
to collect the information about the children and their families in a time period of
approximately 5 minutes before the procedure by face-to-face interview method by the
researcher using the "Descriptive Information Form". In addition, the researcher will
introduce the measurement tools that they will score to children and parents.
According to the routine application of the blood collection unit, the features related to
the blood collection process are listed below:
- The area where the venous blood sample is taken (thick in the antecubital fossa/ vein
near the skin surface)
- The thickness of the needle used in the process (21 G 38 mm needle)
- Blood collection technique used (using the same type of tourniquet)
- Environmental factors (Heat, light and noise control)
- phlebotomy chair for children
- The antiseptic solution used (70% alcohol)
- Processing time (Average 3 minutes)
In data collection, Child and Parent Diagnosis Form, Children's Visual Analog Scale (VAS),
Wong Baker Faces Pain Scale (Wong-Baker Faces Pain Scale- W-BFS), Child Fear Scale (CDS),
Child Anxiety Scale-State Scale (CAS) were used. -D), two different cognitive-behavioral
combined program applications including PedsQL Health Care Parental Satisfaction Scale, Video
game or kaleidoscope will be used.
Child and Parent Identification Form The sample is a form prepared by the researcher by
taking expert opinion and reviewing the literature to obtain information about the selected
children and their parents. Form; it consists of questions that include the demographic
characteristics of the child and his parents, whether the child has any disease, and the
variables that may affect the child's pain and fear levels due to the procedure. Before
starting the research, the interview and observation form will be applied to five children
and their parents. Incomprehensible parts will be corrected and finalized. These children and
their parents will be excluded from the research.
Visual Analog Scale (VAS-Visual Analog Scale) The VAS is usually presented as a 10 cm line
with one end marked 'no pain' and the other 'worst imaginable pain'. Patients are asked to
mark the severity of their pain on a 100 mm line. The point marked by the patient is measured
from the 0 point and the severity of the pain is determined. VAS for children over 7 years
old is defined as easy to understand and easy to apply. This scale used in this study will
only be evaluated by the child. Studies have shown its validity and reliability. It has been
stated that it is suitable for use in all cultures because it is a visual scale.
Wong Baker Faces Pain Comparison Scale (W-BFS) It is one of the most commonly used scales to
measure the severity of pain in children. This scale was developed by Donna Lee Wong and
Connie Morain Baker in 1981 and revised in 1983. The scale is used in the diagnosis of pain
in children aged 3-18 years. It has been reported that the use of W-BPS is safe in children
older than three years who can verbally express the degree of pain. There are face shapes and
numbers on the scale. Pain is graded between "0" and "10" points. The level of pain felt is
expressed with increasing degrees of facial expression. Ask the children "Which face shows
your pain?", "How many points would you give your pain?" He will be asked to rate his pain by
asking questions such as The parent will also be asked to evaluate the pain according to the
child's reaction. Finally, the observer nurse will be asked to rate the pain she observes
according to the child's reaction in another environment, without seeing the score given by
the child and the parent. It has been stated that it is suitable for use in all cultures
because it is a visual scale.
Child Fear Scale (CLO) This scale was developed by McMurtry et al. in 2011. It was translated
into Turkish and Turkish validity and reliability study was conducted by Gerceker et al. It
is used to measure the level of fear of children. In this method, the child is shown a
picture containing five facial expressions evaluated between 0 and 4. 0 indicates no fear; 4
shows the highest fear. These;
- "0 " neutral expression
- "1" very little fear
- "2" some fear (some anxiety)
- "3" more fear (more anxiety)
- "4" is considered the highest possible fear (severe anxiety). This scale can be applied
by both the researcher and the family to measure fear before and during the procedure.
Before the procedure, children will be told how to use the scale. When the child
expresses that he understands, he will be asked to express how afraid he is of the
bloodletting. Ask the children, "Can you look at these faces and pick a face that shows
how scared you are without blood draw?" You will be asked to score by asking. The score
given by the child will be recorded. Likewise, the parent and the observing nurse will
be asked to determine the child's fear level without showing it to the child. Finally,
after the procedure, the children asked, "Can you choose the face that shows how scared
you are during the blood draw?" and will be asked to score according to their facial
expressions. The parent will also be asked to rate how scared the child is based on
facial expressions, without seeing the child's evaluation during the blood draw.
Likewise, the observing nurse will rate the child's fear level and the scores will be
recorded. In order to use the scale in this study, the author, who made the Turkish
validity and reliability, was contacted via e-mail.
Cognitive-Behavioral Combined Program The Cognitive-Behavioral Combined Program is based on
the literature on the subject and taking into account the developmental characteristics of
children. Then, opinions were received from experts in the field regarding the program. The
program has been updated in line with expert opinions. Five children will be piloted for the
implementation of the Cognitive-Behavioral Combined Application Package. The pilot
application will be recorded on video and these recordings will be presented to the expert
team. Children included in the pilot will not be included in the analysis of the study.
Video Game (Use of Visual and Audio System) In this method, which allows to actively divert
attention by giving visual and auditory stimuli together, the focus of attention is drawn to
a different place than pain, with the simultaneous activation of many senses. Kaheni et al.
(2016) with 80 children with second-degree burns, the children in the experimental group were
distracted from pain with a video game during dressing change. It was found that the mean
pain score of the children in the experimental group made a significant difference compared
to the control group (p<0.05). While 70% of the children in the control group experienced
severe pain due to dressing change, most of the children in the experimental group (77.5%)
had "some pain".
During the bloodletting process, children in the video game group will be played with audio
and visual video games that they can play with one hand. Thus, children will be provided with
both visual and auditory stimuli. It will be preferred that children play the video game that
they have knowledge about and know how to play the game. For this reason, children in the
video game group will be given the chance to choose video games suitable for their age and
development level on their parents' smartphones. These video games within the scope of the
research will not be named and will not be promoted/advertised.
kaleidoscope Kaleidoscope is a game material in which colorful patterns are seen. When
looking inside the kaleidoscope, there are patterns obtained by the reflection of two mirror
lights, which are adjacent to each other with an inclination of 60 degrees between them. When
the child turns the lower part of the kaleidoscope and looks through the lens, the beads in
the kaleidoscope form different patterns. Patterns that appear in different ways attract the
child's attention and distract him. In the study of Prajapati (2018), kaleidoscope was found
to be effective in reducing pain during blood collection compared to the control group. In
the study of Kunjumon and Upendrababu (2018), kaleidoscope was found to be effective in
managing pain during intravenous cannulation in children aged 4-6 years. In the research
conducted by Semerci and Akgün Kostak (2020), it was determined that the kaleidoscope is
effective in reducing pain in children aged 6-12 years. As a result of the research, it was
found that distraction cards are more effective in reducing the pain felt than the
kaleidoscope.
In this study, a kaleidoscope with colorful patterns that can be used by children with one
hand will be used. In the research, the kaleidoscope will be introduced to children and how
to use it will be explained. After the procedure, the kaleidoscope will be disinfected using
appropriate disinfectant materials.
Data collection will be done on the basis of volunteering to participate in the research.
Names of people are not requested and the information obtained from the forms will be kept
confidential and will be used only within the scope of this research. Written consent will be
obtained for the study and the child and parent will have the right to separate at any stage
of the study. The methods to be used in the study do not contain any health risks. When an
unexpected situation develops, the studies will be terminated and the necessary intervention
will be made.
Ethical and Legal Aspects of Research In order to carry out the research, first of all,
permissions were obtained from the authors, who made the Turkish validity and reliability of
the scales to be used in the research, via e-mail. The purpose of the study will be explained
to the families of the children who meet the research group selection criteria, their
questions will be answered and their written consent will be obtained. It will be explained
to the parents that the information they give will be kept confidential and will not be used
anywhere else. In addition, those who do not want to participate in the study with verbal
permission from the children will not be included in the study. In the research, since the
use of the human phenomenon requires the protection of individual rights, the relevant
ethical principles "Informed Consent Principle", "Volunteering Principle" and "Principle of
Protection of Confidentiality" will be fulfilled.
