Proof-of-Concept Study of the SNOEZELEN Device on Anxiety Symptoms in Patients Hospitalized for Chemotherapy in a Pediatric Oncology Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Semi-structured research interview
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the Snoezelen multisensory relaxation approach can reduce anxiety symptoms in children and adolescents aged 8 to 17 years hospitalized for chemotherapy in a pediatric oncology unit.
Researchers will compare patients' symptoms during a chemotherapy cycle with Snoezelen sessions to a previous cycle without Snoezelen, in order to assess changes in psychological and physical well-being.
Participants will:
- Be enrolled between their first (without Snoezelen) and second (with Snoezelen) chemotherapy cycles
- Complete self-report questionnaires on anxiety, depression, quality of life, and nausea
- Receive 45-minute Snoezelen sessions every two days during their second hospitalization
- Participate in a semi-structured interview after the final session
- Provide data on medications (anxiolytics, antiemetics) and vomiting frequency during both hospitalizations
详细描述
This is a monocentric proof-of-concept study using mixed methods (quantitative questionnaires and qualitative interviews) to explore the potential benefits of Snoezelen as a supportive care intervention in pediatric oncology.
The goal of this interventional study (minimal risk clinical trial - RIPH2) is to evaluate the effect of the Snoezelen multisensory relaxation approach on anxiety symptoms in children and adolescents aged 8 to 17 years who are hospitalized for chemotherapy in a pediatric oncology unit.
The primary research question is:
- Does the use of Snoezelen reduce anxiety symptoms during hospitalization for chemotherapy in pediatric cancer patients?
Secondary research questions include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patient
- •Treated in the Paediatrics/AJA department of the Oscar Lambret Centre for cancer (all types of cancer)
- •Hospitalisation for several days
- •Highly emetogenic chemotherapy treatment: this corresponds to all in-patient treatments carried out in the Paediatrics/AJA department.
- •Age at diagnosis : ≥ 8 years and < 18 years.
- •French language
- •Information for the patient and those with parental authority; consent signed by the patient and those with parental authority.
- •Valid social security cover
排除标准
- •Contraindication to SNOEZELEN:
- •Claustrophobia
- •Presence of psychiatric, addictive or cognitive disorders that would prevent compliance with the protocol requirements;
- •State of health not allowing participation in the study (severe fatigue, symptoms refractory to treatment).
- •Pregnant or breast-feeding women
研究组 & 干预措施
Snoezelen
Participants will be enrolled between their first chemotherapy cycle (without Snoezelen) and their second cycle (with Snoezelen). During the study, they will complete self-report questionnaires assessing anxiety, depression, quality of life, and nausea. They will receive 45-minute Snoezelen sessions every two days during their second hospitalization. After the final session, participants will take part in a semi-structured interview. In addition, data will be collected on medications administered (anxiolytics and antiemetics) and on the frequency of vomiting during both hospital stays.
干预措施: self-report questionnaires, research interviews (Other)
结局指标
主要结局
Semi-structured research interview
时间窗: At the end of the 2nd course of chemotherapy and no more than 2 weeks after the last Snoezelen session, 1 month after inclusion
Interview with a research psychologist to find out how teenage children feel
次要结局
- Number of vomits(Periprocedural)
- Generalized Anxiety Disorder - GAD-7(Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months)
- Anti-emetic treatments(Periprocedural)
- Child-Self Report - PedsQL(Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months)
- Anxiolytic treatments(Periprocedural)
- BARF scale (Baxter Retching Faces)(Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months)
- Children's Depression Inventory - CDI(Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months)
- Child Anxiety Related Emotional Disorders - SCARED(Before the 2nd chemotherapy treatment, before the 1st Snoezelen session and At the end of the 2nd chemotherapy treatment and no more than 2 weeks after the last Snoezelen session = at 15 days and at 1 months)