Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04932720 |
| Other study ID # |
11814 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 19, 2020 |
| Est. completion date |
May 19, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pediatric oncology patients experience physical and psycho-social symptoms that negatively
affect their quality of life during treatment. "Yoga" practices, known as a unique physical
activity that combines mind-body awareness and breathing exercises to improve the quality of
life of pediatric oncology patients, have recently become popular.
The study was conducted experimentally in the form of pre-test and post-test with 30
controls, 30 experimental group children who were treated in the Pediatric Oncology /
Hematology service of a university hospital and their parents, in order to investigate the
effect of children's yoga program on the quality of life of pediatric oncology patients.
Ethics committee, institutional and parental consent was obtained. Data were collected using
a questionnaire form and the Pediatric Quality of Life Inventory "PedsQL (4.0)". Participants
filled out the Pediatric Quality of Life Inventory "PedsQL (4.0)" Child and Parent Form
before the 3-week (6 sessions) yoga program and salivary cortisol samples were taken from the
children. These procedures were repeated after the yoga program. Anova test and "Paired
sample t" test were used among statistical analysis methods. Statistical significance was
accepted as p <0.05.
Description:
A questionnaire form was used to learn the socio-demographic characteristics of the children
participating in the study and their families. The survey questions are: (age of parents,
employment status, child's age, gender, maternal/paternal age, income status, diagnosis of
the child, hospitalization the reason (chemotherapy, new diagnosis, relapsed? hospitalized
for side effects of the disease? how much whether he was diagnosed a long time ago, how long
he has been in the hospital, whether he went to school, whether he had previous yoga
experience, whether he had knowledge about children's yoga before.
In order to demonstrate the effectiveness of the child yoga program, the study was conducted
with pre-test and post-test. Before the first yoga session, the experimental and control
group caregiver parents and children was completed the quality of life inventory.
The children's yoga program lasted for 3 weeks, 2 sessions per week. At the end of the 6th
session, parents and the child's quality of life inventory was repeated.
In order to evaluate the effect of yoga on stress of children, cortisol from saliva samples
were taken both groups before the program starts.The measurement was performed for both
groups after a 3-week (6 sessions) yoga program.
The hypotheses in the study can be summarized as follows:
H1: Physical activity pre-test and post-test scores of the control and experimental groups
There is a significant difference between the groups in favor of the experimental group.
H2: Emotional functionality pre-test and post-test scores of the control and experimental
groups there is a significant difference between the groups in favor of the experimental
group.
H3: Social functionality pre-test and post-test scores of the control and experimental groups
there is a significant difference between the groups in favor of the experimental group.
H4: School functionality pre-test and post-test scores of the control and experimental groups
there is a significant difference between the groups favor of the experimental group.
H5: Cortisol levels, pre-test and post-test scores of the control and experimental groups
there is a significant difference between the groups in favor of the experimental group.
SPSS 22.0 Statistical Package for the Social Sciences program used for data
analysis.descriptive, parametric and non-parametric statistical analyzes, mean, standard
deviation, median, frequency, percentile, minimum, maximum values calculated. The
effectiveness of the yoga program was measured using the anova (mixed anova) test and the
"Paired sample t" test. p<0.05 value was accepted as the statistical significance limit.
Chıld Yoga Programme:
In our study, Hatha Yoga, one of the known and widely practiced yoga types all over the
world. (HY) consisting of components; asanas (yoga poses), pranayamas (breathing techniques),
relaxation, relaxation exercises and meditation sessions were prepared. Sessions are 45
minutes; For those who are new to yoga for the first 15 minutes; mental and physical
preparation; asanas, pranayamas taught, drama followed by breathing exercises and asanas in
the next 30 minutes, relaxation in the last 15 minutes techniques (imaginary journey) and
meditation.
