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临床试验/NCT05895357
NCT05895357已完成不适用

The Effect of Music Therapy on Comfort, Pain and Anxiety in Patients With Bone Marrow Aspiration and Biopsy: A Randomized Controlled Research

Izmir Bakircay University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Visual Analog Scale (VAS) Pain and Comfort

研究概览

简要总结

Objectives: This study was conducted to determine the effect of music therapy on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy.

Methods: This research was conducted as a randomized controlled study in the hematology polyclinic of a university hospital. Music therapy will used with the intervention group throughout the procedure. During data evaluation, paired t-test, independent t-test and effect size will used. The sample group was calculated based on the sample groups of other studies in the literature (Çelebi et al., 2020; Özdemir et al., 2019). According to the preliminary power analysis results using the G.Power 3.1.9 program, the sample size was calculated at 80% power, at medium effect size at 5% alpha value. According to the analysis results, the sample size per group was calculated as 30. However, since there was 10% probability that some patients may drop, the sample size for the study was recalculated as 66 (Experimental Group: 33, Control Group: 33).The patients will informed about using music. In addition, it will explained that they could adjust the sound levels and that they should report when they are disturbed by the tone. Music continued throughout the process. Communication with the patient will maintained, and symptoms such as discomfort, anxiety were observed throughout the procedure. The music player will switched off after the procedure was completed. The patients will asked whether they had any discomfort while the music played. TThe music therapy will last an average of 30 minutes. After completing the procedures, the patient's pain, comfort, and anxiety levels were re-evaluated using VAS and STAI.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of hematological malignancy (defined as multiple myeloma, Chronic Lymphocytic Leukaemia, Myelodysplastic syndrome or indolent lymphoma)
  • 18 years of age or older,
  • Must be able to speak Turkish

排除标准

  • Hearing impairment
  • hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
  • Sever anxiety disorder
  • Parkinson's disease
  • Alzheimer's disease
  • Major depression

结局指标

主要结局

Visual Analog Scale (VAS) Pain and Comfort

时间窗: 10 minutes

The scale, used to measure patients' subjective pain and comfort, was developed by Price et al. (1983) (Price et al., 1983). This scale consists of a 10 cm horizontal or vertical line with both ends representing the minimum and maximum scores for pain and comfort (0: no pain/no discomfort (very comfortable), 10: most severe pain/very uncomfortable (not at all). Comfort was defined by patients as a pleasant feeling and as the absence of physical discomfort. The patients will asked to indicate their pain severity and comfort on the scale. The distance between the indicated point and the lowest endpoint of the line will measured in centimeters using a ruler, and the numeric value will assigned as the individual's pain score.

次要结局

  • State Trait Anxiety Scale (STAI)(10 minutes)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

seda şahan

Phd research assistant

Izmir Bakircay University

研究点 (2)

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