跳至主要内容
临床试验/NCT06056713
NCT06056713Enrolling By Invitation不适用

The Effect of Hand Massage on Fatigue in Women With Cancer Receiving Brachytherapy Treatment

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
24
试验地点
2
主要终点
Brief Fatigue Inventory (BFI)

研究概览

简要总结

This randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving BT therapy. Randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in Turkey. When 12 patients were included in each group, it was determined that the power was 90% at the 5% Type I error level, and a total of 24 women with gynecological cancer were included in the study. The primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. Patient Information Form and Brief Fatigue Inventory (BFI) used. This study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.

详细描述

Therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving BT therapy. . This randomized clinical trial was conducted.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and over,
  • underwent BT regularly
  • Patients who volunteered to participate in the study

排除标准

  • Having skin problems
  • with metastases,
  • have bleeding or coagulation disorders,
  • using complementary integrated therapy during the study,
  • Having edema or wound in the hand area,
  • not wanting to get a massage
  • Patients receiving general anesthesia during the procedure

结局指标

主要结局

Brief Fatigue Inventory (BFI)

时间窗: The scale was filled in the baseline (after of the Hand massage).]

The BFI, developed by Mendoza et al. (1999), was used to rapidly assess the severity and impact of cancer-related fatigue on daily living activities \[33\]. This inventory has nine items and measures fatigue severity (questions 1, 2, and 3) and fatigue interference in daily life activities (questions 4a, 4b, 4c, 4d, 4e, and 4f). Its reliability and validity, in the Turkish context, were determined by Usta Yeşilbalkan and Karadakovan (2005) and had a Cronbach's alpha value of Turkish version of 0.97 \[34\]. Each item of the BFI that consists of 9 items takes a value between 0-10 points.; higher scores indicate greater fatigue scores. Fatigue severity score is calculated by nine items and whereas fatigue interference score is calculated by summation of questions 4a, 4b, 4c, 4d, 4e, and 4f.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Efe Arslan

ErciyesU

TC Erciyes University

研究点 (2)

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