- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04932720
Efficacy Of Child Yoga Programme on Quality of Life of Pediatric Oncology Patients.
Efficacy of Child Yoga Programme on Quality of Life of Pediatric Oncology Patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Adana, Turkey
- Cukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Of the participating children, those who did not have any other accompanying disease and did not have developmental disorders were included in the study.
Exclusion Criteria:
- Children who were not approved by the Pediatric Oncology unit responsible doctor for inclusion in the yoga program constituted the limitation of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental group
Experimental group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease.
|
Yoga sessions were in the form of 6 sessions and were held as 2 sessions per week.
The program was given by an expert yoga instructor who has an international "Yoga Alliance" approved child and adolescent yoga certificate.Consisting of the components of Hatha Yoga (HY), one of the yoga types known and widely practiced all over the world; Sessions consisting of asanas (yoga postures), pranayamas (breathing techniques), relaxation, relaxation exercises and meditation were prepared.
Sessions are 45 minutes; For those who are new to yoga for the first 15 minutes; mental and physical preparation; asanas, pranayamas were taught, drama followed by breathing exercises and asanas in the next 30 minutes, relaxation techniques (imaginary journey) and meditation in the last 15 minutes.
|
No Intervention: control group
Also the control group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Inventory (PedsQL 4.0) of 8-12 and 13-18 age were used to evaluate the impact of the child yoga program on quality of life of pediatric oncology patients.
Time Frame: 3 weeks
|
A questionnaire form was used to learn the socio-demographic characteristics of the children and their families.
Quality of Life Inventory (PedsQL 4.0) of 8-12 and 13-18 age child and parent form were used to evaluate the impact of the child yoga program on quality of life of pediatric oncology patients.It is a versatile inventory of 23 items covering school functions (5 Items), social functions (5 Items), emotional functions (5 Items), physical functions (8 Items).
Saliva samples were taken from the experimental and control groups to measure the stress levels of the children with the cortisol kit.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şenay Çetinkaya, Cukurova University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Cancer
-
Emory UniversityNational Cancer Institute (NCI)Recruiting
-
Ann & Robert H Lurie Children's Hospital of ChicagoSilicon Valley Community FoundationUnknownCancer | Pediatric CancerUnited States
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
Alexandria UniversityCompletedPediatric Cancer | Invasive CancerEgypt
-
University of California, San DiegoNational Cancer Institute (NCI); Dana-Farber Cancer Institute; University of... and other collaboratorsNot yet recruiting
-
Immune Oncology Research InstituteRecruitingContinuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With DexamethasonePediatric CancerArmenia
-
Connecticut Children's Medical CenterThe Hospital for Sick ChildrenRecruitingPediatric CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingPediatric CancerUnited States
-
Erin RowellRecruiting
-
Giselle ShollerRecruiting
Clinical Trials on chıld yoga programme
-
Chinese University of Hong KongActive, not recruitingPsychosocial Problem | Disability, Adolescent LearningHong Kong
-
Revmatismesykehuset ASSouth-Eastern Norway Regional Health AuthorityCompletedMusculoskeletal Diseases or ConditionsNorway
-
University of HelsinkiFinnish Medical FoundationCompleted
-
Universität Duisburg-EssenCompleted
-
Region SkaneLund UniversityCompleted
-
University of Texas at AustinCompleted
-
Universidad San JorgeHospital Royo Villanova; Hospital Real Nuestra Señora de GraciaCompletedFatigue | Coronavirus | Musculoskeletal ComplicationSpain
-
Oxford Brookes UniversityNational Institute for Health Research, United Kingdom; Royal Berkshire NHS... and other collaboratorsCompleted
-
Adiyaman University Research HospitalCompletedDepression | Stress | Anxiety | Psychological ResilienceTurkey
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaCompleted