Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05250544 |
| Other study ID # |
stress ball-breathing exercise |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2022 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Karamanoglu Mehmetbey University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The COVID-19 pandemic continues to be one of the longest lasting pandemics experienced in
recent times. Although the disease shows symptoms in different ways, the most effective
diagnostic method known is the PCR test. This procedure is an unknown test method that many
people have never had in their lifetime. Uncertainty in any subject causes stress and fear in
the person. When the suspicion of a disease is added to this situation, the situation can
reach even more serious dimensions. For this reason, it can be said that the PCR test can
cause many problems, especially fear and pain. The most important health professional that
the patient can reach before, during and after the test is the nurse. In order for the nurse
to complete the test in a short time and with success, it may be necessary for the applicants
to keep their fear levels under control and to support their fear management. In addition,
the nurse plays an important role in the assessment and management of pain.
In the literature review, no study was found on reducing the fear and pain of the adolescents
who gave the PCR Test. It is also thought that breathing exercises and stress ball can be an
advantageous method in reducing pain and fear, considering their easy accessibility,
affordable cost and long-term use. For this reason, this study was planned to determine the
effect of stress ball and breathing exercises on the management of fear and pain that may
occur due to PCR testing.
Description:
Research type: Randomized controlled experimental study
Dependent variables: Adolescents' fear and pain levels from PCR testing Independent
variables: Stress ball, breathing exercises, demographics
Hypotheses H0: Stress ball and breathing exercises have no effect on reducing fear and pain
during the PCR test process.
H1: Stress ball has an effect on the level of fear that occurs during the PCR Test process.
H2: Breathing exercises have an effect on the level of fear that occurs during the PCR Test
process.
H3: Stress ball has an effect on the level of pain that occurs during the PCR test process.
H4: Breathing exercises have an effect on the level of pain that occurs during the PCR test
procedure.
The population of the study consists of adolescents aged 12-18 years who applied to Karaman
Training and Research Hospital for PCR test. Power analysis was performed using the sample
size 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 adolescents 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 letter A will be used for the control
group, B for the stress ball group, and C for the breathing exercise group. 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. 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.
Tabakalar Blok setler S1 Girl, Afraid CABC, BACC, BACB, ABAA, CACB, ACBB S2 Girl, Not afraid
CACB, BCCC, ABBC, AACB, ABAC, ABAB S3 Man, Afraid ABBB, CBBC, CAAA, ABCC, ABCA, BCAC S4 Man,
Not afraid CABC, BCAB, ACCB, ABAA, CACB, ACBB
Exclusion criteria from the study;
- Inability of the adolescents in the stress ball group to use the stress ball effectively
throughout the procedure.
- Identification of extreme values that may affect the research data
- Child or parent's wish to leave the study
In data collection, Child and Parent Diagnosis Form, Children's Fear Scale (CFS), Wong Baker
Faces Pain Scale (W-BFS), Stress ball and Breathing exercises applications will be used.
Child and Parent Identification Form It is a form prepared by the researcher by taking expert
opinion and reviewing the literature to get information about the selected children and their
parents for sampling. 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.
Children's Fear Scale (CFS) The CFS, which was first used in 2003, is a scale with proven
validity and reliability developed to assess the child's fear level. Patients over the age of
five can easily understand this method. There are five different facial expressions with no
fear at one end of the scale and very intense fear at the other end, and are evaluated
between 0-4 points. 0: no fear- 4: expresses extreme fear.
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 (Wong and Baker, 1988).
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.
It has a plastic and soft structure that can be held comfortably. Each ball is about 7cm long
and wide, it is a soft toy stuck in the hand, manipulated with fingers to relieve stress and
muscle tension, exercise muscles. Contains no risk for children (not consisting of small
parts that can be swallowed). The ball is in different colors such as orange, blue, green.
Since all adolescents included in the study applied to the hospital with the suspicion of
illness, in order to minimize the transmission of the disease by contact, separate balls will
be given to all adolescents in the stress ball group and the balls will not be taken back.
Breathing Exercises Breathing exercises are applied for about 10 minutes and are mostly
applied in the control of fear and stress. It has four different periods and each period
lasts an average of four seconds. These periods are; breathing, waiting, breathing out and
waiting periods. You can do this technique on proper breathing by following the steps below.
- Let's place our right hand on our chest and our left hand on our stomach.
- Let's breathe through our nose (counting to 4 inside us) wait for 4 seconds and breathe
out slowly through our mouth (counting up to 4).
- If our rib cage (right hand) moves during breathing, it means we are breathing
incorrectly.
- Let's just pay attention to the following while breathing: Our stomach will swell (left
hand will move) when we breathe in, it will stay swollen as long as we hold our breath,
and it will move inwards when exhaling.
In order for the adolescent to perform these applications correctly, instructions will be
given by the researcher, and it will be ensured that they practice for about 10 minutes. In
order to prevent the risk of contamination during breathing, the exercise will be done in a
separate room, and the patient and the researcher will be masked. The room will be
disinfected after each application.
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 scale to be used in the research, via
e-mail. The aim of the study will be explained to the adolescents and their families 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 and written consent from the adolescents 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.
The data will be analyzed using descriptive statistics (percentage, mean, standard deviation,
min-max value), difference analyzes (t-test in independent groups, paired t-test, mAnova,
Mann Whitney U, Kruskal Walles), advanced analyzes when necessary (Tukey, Duncon etc.) and
correlational analyzes (eg Pearson correlation analysis and Linear Regression analysis).
