Effectiveness of Pediatric Education Discharge Support Services (PEDSS) on management of symptoms and complications for children with Hematological cancer in a tertiary care centre
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of PEDSS on management of symptoms and complications at home for children with hematological cancer.
研究概览
简要总结
This randomized controlled trial at AIIMS Rishikesh will assess the effectiveness of Pediatric Education Discharge Support Services (PEDSS) in managing symptoms and complications in children with hematological cancer.
Study Design****Approach: QuantitativeSetting: Hemat-oncology clinic & pediatric hematology wardPopulation: Children (3-18 years) with hematological cancer & their parentsSample: 100 participants (50 control, 50 experimental)Sampling: Convenient sampling with random allocationBlinding: Statistician blindedVariables****Independent: PEDSSDependent: Symptom management, unplanned service use, parental perception & satisfactionExtraneous: Demographic & clinical factorsEligibility Criteria****Inclusion:
-
Newly diagnosed children (3-18 years) & their parents who speak Hindi/English. Exclusion:
-
Children with cognitive disabilities, parents with psychiatric illness, unwilling participants
**Intervention (PEDSS)**A nurse-led education program to improve home management:
- Video education on symptom management (nausea, pain, fatigue, infections, etc.)
- Interactive checklist for medication, follow-up, home care, nutrition
- Pamphlets with simple instructions & visuals
- Peer support group (in-person & WhatsApp)
- Emergency contact support for caregivers
Implementation****Teaching strategies: Video, discussions, teach-back method, role modelingValidation: By experts in pediatric nursing, oncology, and nutritionTraining process: Informal discussions, interactive demonstrations, correction & reteaching as neededEmergency support: Telephonic assistance for urgent queries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3 -18 years and diagnosed with hematological cancer
- •Parent, caregiver, legal guardian aged over 18 years of selected child.
- •Parent needed to speak Hindi or English.
- •Diagnosed at least 1 month before or within 5 years after the diagnosis., treatment initiated, admitted at least once prior.
排除标准
- •Children with cognitive disabilities.
- •Parent, legal guardian, or caregiver who is having any psychiatric illness.
- •Children, parent, legal guardian, or caregiver who are not willing to participate in study.
结局指标
主要结局
Evaluate the effectiveness of PEDSS on management of symptoms and complications at home for children with hematological cancer.
时间窗: 1. At discharge | 2. 1 months from discharge | 3. 2 months from discharge
次要结局
- 1. To explore the problems faced by children and parents at home related to management of symptoms and complications for children with hematological cancer.(2. Development and validation of Paediatric Education Discharge Support Services (PEDSS) for children with hematological cancer.)
研究者
VANITA
All india institute of medical sciences