The Effect of Touch on Pain and Anxiety During the Bone Marrow Biopsy Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Identify correlation between demographics and interventional response
研究概览
简要总结
This study is analyzing the benefit of untrained touch provided during a bone marrow biopsy procedure as compared to performing the procedure without providing it.
详细描述
Two protocol-identified licensed nursing aides (LNA) will provide an unstructured simple touch intervention that requires no special training other than being oriented to "rub patient's feet" during the procedure. Data will be collected through patient-reported outcomes to determine if "untrained" touch has therapeutic results in managing a patient's pain and anxiety during a bone marrow biopsy procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from Norris Cotton Cancer Center who have been scheduled for a bone marrow biopsy at the Outpatient Surgical Center at Dartmouth-Hitchcock Medical Center.
- •Subjects must be able to read and write in English to provide informed consent and fill out the questionnaires.
排除标准
- •Patients who do not wish to have their feet and lower legs touched during the procedure
- •Open sores on their feet or lower legs.
结局指标
主要结局
Identify correlation between demographics and interventional response
时间窗: During the study procedure
Secondary endpoints will include identifying any correlation between demographic data collected and response to the intervention. The patient experience will be evaluated by using a visual analog scale at the completion of the procedure via paper and pencil that the subjects will complete independently. These open ended questions will be used to inform larger study questions in the future. Abstracted and deidentified summaries of responses will be prepared by the study PI.
Evaluate patient-reported anxiety levels
时间窗: During the study procedure
The six -item short form Spiellberger State-Trait Anxiety Inventory (STAI), a self-reported questionnaire, will be administered on pencil and paper. Possible ranges of scores on the 6-item questionnaires vary from 6 to 24, with separate scores for both the state and trait anxiety sections. Answers to each question range from 1 to 4, 1 being no anxiety at all to 4 being very high anxiety (Julian, 2014). Patients will complete the short-form STAI before and after the procedure.
Evaluate patient-reported pain levels
时间窗: During the study procedure
Patients be asked to describe what their pain level was before, at its worst point during the procedure and after the bone marrow biopsy. The Visual Analog Scale (VAS) will be used on a 0 to 10 scale, 0 being no pain at all and 10 being the worst pain imaginable.
次要结局
未报告次要终点
研究者
Anna D. Schaal
Hematology Nurse Practitioner
Dartmouth-Hitchcock Medical Center