Pediatric CancerNCT06651918
Effects of Yoga on Children With Cancer
A study testing yoga practise in people with Pediatric Cancer, run by TC Erciyes University.
Trial summary
This study was planned as a randomized controlled experimental study with a pre-test-post-test design to determine the effect of yoga practice accompanied by a specialist yoga instructor on fatigue, quality of life and symptom control in children diagnosed with cancer between the ages of 8-12.The main questions it… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- yoga practise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2025
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant must be between the ages of 8-12,
- He/she must not have a chronic or genetic disease other than cancer,
- He/she must not have a physical, mental or neurological disability,
- The participant must have a mother who is at least a primary school graduate,
- The participant must be able to speak and understand Turkish,
- Both the participant and his/her parents must be open to communication and cooperation,
- Participants will be included in the study if both the participant and his/her parents agree to participate in the study voluntarily and give verbal and written consent.
Who cannot join
- Participants who do not want to participate in the study or who want to leave the study, who have communication difficulties, and who have solid tumors (Osteosarcoma, Ewing sarcoma, etc.) that prevent them from doing yoga will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Yoga Practice on Fatigue Quality of Life and Symptoms in Children With Cancer
This study was planned as a randomized controlled experimental study with a pre-test-post-test design to determine the effect of yoga practice accompanied by a specialist yoga instructor on fatigue, quality of life and symptom control in children diagnosed with cancer between the ages of 8-12.The main questions it aims to answer are:
- Does yoga practice applied to children diagnosed with cancer reduce fatigue in children?
- Does yoga practice applied to children diagnosed with cancer affect their quality of life?
- Does yoga practice applied to children diagnosed with cancer affect the symptoms experienced by children?
Before and after yoga practice, children diagnosed with cancer will answer survey and scale questions about fatigue, quality of life and symptoms.
Read the detailed description
Cancer is among the major health problems all over the world. Every year, 400 000 children are diagnosed with cancer all over the world and 3500 children are diagnosed with cancer every year in our country. It is estimated that the number of children diagnosed with cancer will increase exponentially every year. In addition to this increase in the incidence of childhood cancers, developments in medicine and technology in recent years have enabled the life expectancy of children diagnosed with cancer to extend. However, cancer and its treatment cause physiological and psychosocial problems that can negatively affect the lives of children diagnosed with cancer. Symptoms such as pain, fatigue, sleep problems, nausea/vomiting, loss of appetite, physical activity intolerance, stress/anxiety are common in children with cancer, depending on the disease and its treatment, and they negatively affect the quality of life of children In order to reduce the negative effects of symptoms caused by cancer and its treatment, it is important to separately evaluate and address the quality of life of children diagnosed with cancer and factors such as sleep, fatigue, stress and physical activity, which constitute the quality of life components. It is recommended to use complementary treatment methods, including mind-body practices, to improve the quality of life of children diagnosed with cancer and to reduce the symptoms and effects that may occur. Complementary treatment methods include massage, acupuncture, breathing exercises, relaxation techniques, laughter therapies and yoga. Children's yoga, which has been used in children with cancer in recent years, is defined as physical activity that provides strength, balance and movement in children, as well as activities that increase awareness through breathing work. It has been determined that yoga activity has positive effects on the physiological and psychological measurements and quality of life of children with cancer.
The fact that yoga activity can be done in any area without the need for any materials provides an advantage for children diagnosed with cancer. The play and activity needs of children with cancer who are isolated due to cancer and its treatment must be met under safe conditions. Children's yoga, performed with simple and fun movements in the hospital room, can increase the activity of the child with cancer and meet the need for play and activity. It may also help the child diagnosed with cancer to shift the focus away from the disease and the negative effects that the disease may have caused. Improving the quality of life of children diagnosed with cancer, reducing/controlling the symptoms caused by cancer or its treatment, and planning and implementing new coping methods are among the main goals of pediatric oncology nurses. Although there are studies on the effects of yoga practice on children with cancer in the literature review, there are limited studies on this subject in our country. In line with all these, this research was planned as a randomized controlled experimental study to determine the effect of yoga practice on the symptoms, fatigue and quality of life experienced by children diagnosed with cancer.
- Conditions
- Pediatric Cancer
- Being tested
- yoga practise
- Keywords
- children with cancer, yoga, fatique, quality of life, symptoms of cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga practiseBehavioural
For the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| yoga practise | Experimental | For the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks. Receives: Behavioral: yoga practise |
| survey group | No intervention | No intervention will be made to the children in this group, only survey and scale questions will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Inventory for Children (PedsQL)
The scale, developed by Varni and his colleagues in 2001 and adapted into Turkish by Çakın-Memik et al. (2007), questions the quality of life of children in the areas of physical, emotional, social and school functionality.
Measured: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
Memorial Symptom Assessment Scale (7-12 years old)
The scale, which was developed by Collins et al. in 2002 for use in children with oncology between the ages of 7 and 12, was adapted into Turkish by Şenol and Efe (2022).It is used to evaluate symptoms of pain, numbness, sadness, nausea, pruritus, anxiety, loss of appetite, and insomnia experienced by pediatric oncology patients in the past two days.
Measured: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12
The Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12, developed by Kudubeş, Bektaş and Uğur in 2019, consists of 27 items and 3 sub-dimensions.
Measured: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startJan 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
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 TC Erciyes 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Kalayci, TC Erciyes University
- Investigators
- Emine Erdem, Prof., Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651918
- Sponsor's protocol ID
- ErciyesEKalayci38
- Status last verified
- Oct 2024
- First submitted
- 4 Apr 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Practice on Fatigue Quality of Life and Symptoms in Children With Cancer
- ClinicalTrials.gov ID
- NCT06651918
- Acronym / sponsor ID
- ErciyesEKalayci38
- Conditions
- Pediatric Cancer
- Keywords
- children with cancer, yoga, fatique, quality of life, symptoms of cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Oct 2024 (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.
This study was planned as a randomized controlled experimental study with a pre-test-post-test design to determine the effect of yoga practice accompanied by a specialist yoga instructor on fatigue, quality of life and symptom control in children diagnosed with cancer between the ages of 8-12.The main questions it aims to answer are:
- Does yoga practice applied to children diagnosed with cancer reduce fatigue in children?
- Does yoga practice applied to children diagnosed with cancer affect their quality of life?
- Does yoga practice applied to children diagnosed with cancer affect the symptoms experienced by children?
Before and after yoga practice, children diagnosed with cancer will answer survey and scale questions about fatigue, quality of life and symptoms.
Detailed description
Cancer is among the major health problems all over the world. Every year, 400 000 children are diagnosed with cancer all over the world and 3500 children are diagnosed with cancer every year in our country. It is estimated that the number of children diagnosed with cancer will increase exponentially every year. In addition to this increase in the incidence of childhood cancers, developments in medicine and technology in recent years have enabled the life expectancy of children diagnosed with cancer to extend. However, cancer and its treatment cause physiological and psychosocial problems that can negatively affect the lives of children diagnosed with cancer. Symptoms such as pain, fatigue, sleep problems, nausea/vomiting, loss of appetite, physical activity intolerance, stress/anxiety are common in children with cancer, depending on the disease and its treatment, and they negatively affect the quality of life of children In order to reduce the negative effects of symptoms caused by cancer and its treatment, it is important to separately evaluate and address the quality of life of children diagnosed with cancer and factors such as sleep, fatigue, stress and physical activity, which constitute the quality of life components. It is recommended to use complementary treatment methods, including mind-body practices, to improve the quality of life of children diagnosed with cancer and to reduce the symptoms and effects that may occur. Complementary treatment methods include massage, acupuncture, breathing exercises, relaxation techniques, laughter therapies and yoga. Children's yoga, which has been used in children with cancer in recent years, is defined as physical activity that provides strength, balance and movement in children, as well as activities that increase awareness through breathing work. It has been determined that yoga activity has positive effects on the physiological and psychological measurements and quality of life of children with cancer.
The fact that yoga activity can be done in any area without the need for any materials provides an advantage for children diagnosed with cancer. The play and activity needs of children with cancer who are isolated due to cancer and its treatment must be met under safe conditions. Children's yoga, performed with simple and fun movements in the hospital room, can increase the activity of the child with cancer and meet the need for play and activity. It may also help the child diagnosed with cancer to shift the focus away from the disease and the negative effects that the disease may have caused. Improving the quality of life of children diagnosed with cancer, reducing/controlling the symptoms caused by cancer or its treatment, and planning and implementing new coping methods are among the main goals of pediatric oncology nurses. Although there are studies on the effects of yoga practice on children with cancer in the literature review, there are limited studies on this subject in our country. In line with all these, this research was planned as a randomized controlled experimental study to determine the effect of yoga practice on the symptoms, fatigue and quality of life experienced by children diagnosed with cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga practise | Experimental | Behavioral: yoga practiseFor the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks. |
| survey group | No intervention | –No intervention will be made to the children in this group, only survey and scale questions will be applied. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The participant must be between the ages of 8-12,
- He/she must not have a chronic or genetic disease other than cancer,
- He/she must not have a physical, mental or neurological disability,
- The participant must have a mother who is at least a primary school graduate,
- The participant must be able to speak and understand Turkish,
Key exclusion criteria (1 listed)
- Participants who do not want to participate in the study or who want to leave the study, who have communication difficulties, and who have solid tumors (Osteosarcoma, Ewing sarcoma, etc.) that prevent them from doing yoga will be excluded from 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 |
|---|---|---|
| yoga practiseFor the experimental study, the researcher will contact the participants to be included in the study and the intervention (yoga group) and control groups will be randomly created. The participants will be informed about the study by the researcher and their voluntary consent will be obtained. The researcher will provide information about the Identifying Characteristics Form for Children Diagnosed with Cancer and Their Families, the Quality of Life Scale for Children (PedsQL) and the Memorial Symptom Assessment Scale to be used in the study. The survey and scales will be applied to each participant individually one day before yoga. Then, the Yoga Group will be applied 3 sessions per week, 3 weeks in a row, each session will be 30 minutes. The researcher will repeat the survey and scale questions that he asked the participants before they started yoga at the end of the 3 weeks. | Behavioural | yoga practise |
Primary outcome
Quality of Life Inventory for Children (PedsQL)
Time frame: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
The scale, developed by Varni and his colleagues in 2001 and adapted into Turkish by Çakın-Memik et al. (2007), questions the quality of life of children in the areas of physical, emotional, social and school functionality.
Memorial Symptom Assessment Scale (7-12 years old)
Time frame: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
The scale, which was developed by Collins et al. in 2002 for use in children with oncology between the ages of 7 and 12, was adapted into Turkish by Şenol and Efe (2022).It is used to evaluate symptoms of pain, numbness, sadness, nausea, pruritus, anxiety, loss of appetite, and insomnia experienced by pediatric oncology patients in the past two days.
Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12
Time frame: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure
The Fatigue Assessment Scale for Pediatric Oncology Patients Aged 7-12, developed by Kudubeş, Bektaş and Uğur in 2019, consists of 27 items and 3 sub-dimensions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- 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.
Emine Erdem, Prof. study director
TC Erciyes University
Questions about this trial
What is this clinical trial studying?
A study testing yoga practise in people with Pediatric Cancer, run by TC Erciyes University.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eda Kalaycı, phd student (+0905349538932, eda_kalayci937@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Inventory for Children (PedsQL) (time frame: At the beginning yoga and after three weeks ; survey and scale questions will be applied by the researcher. In addition, in the statistical analysis section of the research, correlation and regression analysis will be conducted between the measure). The study lists 3 primary outcomes in all. 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 22 Oct 2024.