Clinical trial NCT05434871: Yoga in Pediatric Cancer
Official title: The Efficacy of Yoga in Pediatric Cancer Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Pediatric Cancer
Keywords: Pediatric Cancer
Yoga
Physiotherapy
Quality of Life
Fatigue
Pain
Motor Proficiency
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Pediatric cancer patients and their families experience biopsychosocial difficulties as a result of the long and difficult treatment procedure, which have a severe impact on their quality of life. These difficulties might arise as a result of cancer and its treatment. Fatigue, pain, and an impaired motor skills are all common issues. These issues result in body structure and function deficits, as defined by the International Classification of Functioning-Child and Youth (ICF-CY), and have a negative impact on children's activity and participation levels. Yoga is a form of exercise that incorporates breathing methods, physical postures, and meditation. Yoga appears to relieve fatigue and improve quality of life in pediatric cancer patients, according to preliminary studies. However, no randomized controlled trial has been conducted in this population to determine the effectiveness of yoga. The purpose of this study is to assess children's quality of life, fatigue, pain, motor proficiency, participation, coping, and motivation; also to look at the effects of parents on quality of life, depression, fatigue, and care burden in a randomized controlled study.

Detailed description: Childhood cancers are diseases that affect children and their families worldwide and occur in a variety of diagnostic groups. The focus has been on reducing mortality rates and long-term survival expectations in pediatric cancer patients, as well as reducing long-term side effects and improving quality of life, and it has become critical to develop interventions for problems that have long-term consequences. Within the framework of ICF-CY, biological problems such as exhaustion, pain, nausea, vomiting, and sleep difficulties, which are the most common symptoms in pediatric cancer patients, are included in body structure and function disorders. However, rather than cancer, the underlying cause of many difficulties is considered to be the treatment process itself. The symptoms experienced by pediatric cancer patients are moderate to high and are related to the stress level of the parents. As a result, improvements in pediatric cancer patients' symptoms may also lower the burden of care for their parents. Within the scope of the ICF-CY model, these biopsychosocial difficulties encountered by the child and family are interrelated and have an impact on the child's and family's quality of life. Limitations of normal joint movement, contractures, muscle weakness, diminished flexibility and functional mobility, balance and gait problems are among the physical and functional performance deficits reported by pediatric cancer patients as a result of the disease and therapy. Physical disabilities have a negative impact on children's participation in daily activities and their quality of life. As a result, specific therapy strategies aimed at improving children's physical limitations are required. In the current systematic review, it was stated that exercise applied to pediatric cancer patients had positive effects on fatigue, muscle strength, functional mobility, flexibility, sleep, physical activity level, and quality of life. No side effects were observed in the studies. In a meta-analysis, it was found that exercise, regardless of the type of exercise, lowers fatigue in pediatric cancer patients. Yoga is one of the promising approaches for children with cancer. Yoga improves stress and anxiety management, motor performance, concentration ability, and cardiovascular and musculoskeletal system functions in healthy children. Researchers reviewed yoga therapy in adult and pediatric cancer patients. Although yoga has been shown to improve psychological and physical functions in adults with cancer, the same cannot be said for children with cancer. In the literature, there are very few research on the impact of yoga on children with cancer. Children and their parents noted that after practicing yoga, sickness, the need for painkillers, and anxiety levels decreased, while sleep and mood improved. Yoga was useful in reducing stress and anxiety, according to the children and parents. In the existing literature, however, studies exploring the benefit of yoga in pediatric cancer patients are both quantitatively and qualitatively limited. In the literature, there is no randomized controlled trial that looks at the efficacy of yoga in children with cancer. The number of investigations in the literature is restricted to only eight pilot studies. This study is aimed to investigate the effects of yoga on quality of life, fatigue, pain, motor proficiency, and motivation in pediatric cancer patients in order to fill this gap in the literature.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a hematological malignancy or a solid tumor
* Age between 6 years and 12 years
* Received chemotherapy for at least two weeks
* Ability to stand and move without the use of an assistive device
* To be able to read and speak Turkish

Exclusion Criteria:

* Diagnosis of central nervous system tumor, genetic syndrome or neurological disorder
* Surgery planned within the 8-week period planned to participate in yoga
* Refused to participate the study

Primary outcomes:
measure: The Pediatric Quality of Life Inventory (PedsQL) Cancer Module
timeFrame: change from baseline to end of the 8 weeks
measure: Child Fatigue Scale-R 24-Hours
timeFrame: change from baseline to end of the 8 weeks
measure: Pain Flexibility Scale for Children with Cancer
timeFrame: change from baseline to end of the 8 weeks
measure: Bruininks-Oseretsky Test of Motor Proficiency Short Form -BOT-2 SF:
timeFrame: change from baseline to end of the 8 weeks
measure: Pediatric Motivation Scale
timeFrame: change from baseline to end of the 8 weeks
measure: Paediatric Cancer Coping Scale
timeFrame: change from baseline to end of the 8 weeks
measure: Participation and Environment- Children and Youth (PEM-CY)
timeFrame: change from baseline to end of the 8 weeks
measure: The Child Fatigue Scale-Parent Form
timeFrame: change from baseline to end of the 8 weeks
Secondary outcomes:
measure: Nottingham Health Profile
timeFrame: change from baseline to end of the 8 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: change from baseline to end of the 8 weeks
measure: Fatigue Impact Scale
timeFrame: change from baseline to end of the 8 weeks
measure: The Fatigue Severity Scale
timeFrame: change from baseline to end of the 8 weeks
measure: Caregiving Burden Scale for Family Caregivers of Children with Cancer-CBSFC-CC
timeFrame: change from baseline to end of the 8 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References:
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