Technology-Assisted Yoga and Exercise on Chemotherapy-Induced Peripheral Neuropathy and Pain in Children With Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy
研究概览
简要总结
The study was planned to examine the effects of technology-supported yoga and exercise on chemotherapy-induced peripheral neuropathy and pain in children aged 5-18 years with leukemia.
详细描述
The research will be carried out in Marmara University Istanbul Pendik Training and Research Hospital Pediatric Hematology and Oncology Service, and Dokuz Eylul University Pediatric Hematology and Oncology Service. It was planned to include all patients who were selected by the block randomization method, and who met the sampling criteria, in the study. Yoga will be given to the intervention group online. The control group will not be interfered with. Follow-up will be made using data collection tools after taking the study, 3 months later, and 6 months later.
Before starting yoga, "How are you feeling today?" will be asked to child. The yoga session will be individualized according to how the child feels. The content of the yoga sessions will progress in the form of warm-up exercises - breathing work - yoga postures (asana) - meditation - and progressive muscle relaxation exercises. Yoga sessions will be scheduled for 30 minutes. Yoga sessions and progressive muscle relaxation exercises will be held online once a week for eight weeks, then every two weeks for four months.
All yoga sessions will pay attention to the following items:
- Yoga sessions will be stretched according to the child's energy level and comfort.
- If the child expresses that he or she is not feeling well, that yoga session can only consist of breathing exercises and cooling poses.
- The child will be encouraged to express that he/she feels tired when he/she is tired.
- He will be told to move slowly to ensure safety when entering and exiting balance poses.
- The child will be asked what part of his/her body he/she feels while in the pose and where the tension occurs. This will ensure that the child remains safe in the pose.
- If a member of the family wishes to participate while the child is doing yoga, their participation will be supported.
- Movements will be continued by protecting the area with the catheter so that any catheter in the child's body is not bent, twisted, or dislodged.
- Back bending poses with high intensity will not be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of the child is between 6-18,
- •Diagnosed with acute lymphoblastic leukemia,
- •Induction (Steroid and Vincristine) treatment,
- •Being on an inpatient or outpatient treatment,
- •Newly diagnosed or on induction therapy for less than one month,
- •child agreeing to participate in the study voluntarily,
- •Parent agreeing to participate in the study voluntarily,
- •No relapse,
- •Obtaining the consent form from the child and the parent,
- •The child does not have a physical or psychological deficit,
- •The child's yoga and exercise have an electronic device and internet to participate in the intervention.
排除标准
- •The patient's relapse or terminal period,
- •The child and family are not willing to participate in the study,
- •The child has a cognitive, physical, and psychological deficits,
- •The child's illiteracy.
结局指标
主要结局
Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) for peripheral neuropathy
时间窗: during 6 months (at the beginning of the study, 3rd month and 6th month)
Pediatric Modified Total Neuropathy Scale and Total Neuropathy Score-Pediatric Vincristine (TNS-PV) assessment tools will be used. They determine Chemotherapy-induced Peripheral Neuropathy and its severity in children receiving cancer treatment. Each category is scored between 0-4. The highest 32 points are obtained from the scale. The higher the score, the worse the neuropathy. TNS-PV is based on adding constipation and hoarseness to the Pediatric Modified Total Neuropathy Scale.
Adolescent Pediatric Pain Scale for pain
时间窗: during 6 months (at the beginning of the study, 3rd month and 6th month)
Adolescent Pediatric Pain Scale: This scale consists of three independent parts; 1. body outline diagram where the child/adolescent can mark the location of the pain \*Assessment: The child can mark the anterior and posterior sides-upper extremity, lower extremity, head, neck, abdomen, chest, shoulder, back… so that the location and number of the pain area is evaluated 2. 10 cm long, where the pain can mark the severity as "no pain, mild pain, moderate pain, very pain and worst pain possible" word chart scale \* Evaluation: With a scale of 0-10 cm, the pain is evaluated by the child between 0-10 and the pain is defined as "no pain, mild pain, moderate pain, very pain". and defines its intensity by choosing one of the "worst pain possible" 3. word list under 4 dimensions (sensory, emotional, evaluative, time) to indicate the nature of pain.
次要结局
- Pediatric Symptom Screening Scale for chemotherapy related symptoms(during 6 months (at the beginning of the study, 3rd month and 6th month))
研究者
Gülçin Özalp Gerçeker
Assoc. Prof.
Dokuz Eylul University