Pediatric CancerNCT04932720
Efficacy Of Child Yoga Programme on Quality of Life of Pediatric Oncology Patients.
A study testing chıld yoga programme in people with Pediatric Cancer, run by Cukurova University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- chıld yoga programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2020to 19 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Of the participating children, those who did not have any other accompanying disease and did not have developmental disorders were included in the study.
Who cannot join
- Children who were not approved by the Pediatric Oncology unit responsible doctor for inclusion in the yoga program constituted the limitation of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- chıld yoga programme
- Keywords
- Child Health and Diseases Nursing, cortisol, quality of life, stress, yoga
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chıld yoga programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Experimental group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease. Receives: Behavioral: chıld yoga programme |
| control group | No intervention | Also the control group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start19 Jan 2020
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children who were treated at Mersin University Medical Faculty Hospital were determined by the "simple random selection" method and formed the experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N.Ecem Oksal Gunes, Phd, Cukurova University
- Investigators
- Şenay Çetinkaya, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932720
- Sponsor's protocol ID
- 11814
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Child Yoga Programme on Quality of Life of Pediatric Oncology Patients.
- ClinicalTrials.gov ID
- NCT04932720
- Acronym / sponsor ID
- 11814
- Conditions
- Pediatric Cancer
- Keywords
- Child Health and Diseases Nursing, cortisol, quality of life, stress, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 19 Jan 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Children who were treated at Mersin University Medical Faculty Hospital were determined by the "simple random selection" method and formed the experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: chıld yoga programmeExperimental group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease. |
| control group | No intervention | –Also the control group consisted of children aged 8-18 years, who did not have a different disease accompanying the oncological disease. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Of the participating children, those who did not have any other accompanying disease and did not have developmental disorders were included in the study.
Key exclusion criteria (1 listed)
- Children who were not approved by the Pediatric Oncology unit responsible doctor for inclusion in the yoga program constituted the limitation of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chıld yoga programmeYoga 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. | Behavioural | experimental group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şenay Çetinkaya study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chıld yoga programme in people with Pediatric Cancer, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.