Effects of Guided Meditation on Patient Outlook and Symptom Management in Pediatric Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improved anxiety level
研究概览
简要总结
This study will look at the use of relaxation therapy in children with cancer. The study will compared patients who are current receiving treatment for their cancer and those who are currently in remission. Patients will be asked to listen to a short audio recording twice a week prior to going to bed which will walk patients through a mediation session. Surveys will be distributed through parental emails on the first of each month for each child to complete for the duration of 12 months. It is anticipated that the use of relaxation therapy will help to improve anxiety and pain levels in this population.
详细描述
Rationale: The utilization of complementary therapies in the management of cancer have not been extensively studied in the pediatric population. Patients in active treatment and even those in remission may experience higher levels of anxiety and medical complications compared to their counterparts. Complementary therapies such as meditation have been found to improve symptoms and decrease anxiety and pain levels in adult oncology patients.
Objective: The goal of this study is to determine the impact of relaxation breathing with body scan techniques through the utilization of media clips on pediatric oncology patients' complications, hospitalizations, anxiety levels and outlook on diagnosis and treatment management.
Methods: A randomized non-blind control trial will be conducted in order to compare a control to a therapy intervention group. The therapy will consist of a video clip approximately 5 minutes in length. The clip will walk the patient through mindfulness in breathing along with muscle relaxation of each muscle group. This therapy is to be completed three times a week prior to falling asleep. Prior to initiation of therapy a baseline questionnaire will be completed. Following initiation, a follow up survey will be distributed on a monthly basis to assess for symptom severity, number of hospitalizations and patient outlook.
Population: The study population includes patients seen at Janet Weis Children's Hospital's pediatric oncology clinic. Patients must be in the age range of 6-20 years old for the entire year of the study in order to qualify. Exclusion criteria includes patients who are actively receiving drug therapy for anxiety or depression or receiving palliative care. Patients who pass away within the year of study will be excluded.
Time Frame: Following recruitment, each patient will be enrolled for the total of a one-year time frame.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current patient at Geisinger Foss Clinic - oncology department with a diagnosis of cancer for more than 2 months prior to the study start
排除标准
- •Current use of any psychiatric medications including those for anxiety, depression or mood disorders
- •Non-English speaking
- •Patients receiving palliative care
- •Patients with Langerhans' cell histiocytosis, benign teratomas and craniopharyngioma as they do not clearly constitute malignancy
- •Patients with a history of cognitive developmental delay
结局指标
主要结局
Improved anxiety level
时间窗: Measurement will be assessed through study completion, an average of 1 year
Anxiety level will be measured through a series of monthly surveys asking patients to rate how often they experience worry over their diagnosis, school, have difficulty paying attention, feel angry, sad or alone as never, rarely, sometimes or often.
次要结局
- Change in levels of pain(Measurement will be assessed through study completion, an average of 1 year)
- Improved sleep habits(Measurement will be assessed through study completion, an average of 1 year)
研究者
Santisree Tanikella
Physician Pediatrics
Geisinger Clinic