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临床试验/NCT07704502
NCT07704502已完成不适用

The Effect of Isometric Exercise and Dry Heat Application on Venous Fullness and Vein Visibility in Cancer Patients: A Randomized Controlled Trial

Inonu University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
Effects of isometric exercise

研究概览

简要总结

Purpose: This study was conducted to evaluate the effect of isometric exercise and dry heat application technique on venous fullness and vein visibility in cancer patients.

Design: This study is a randomized controlled trial model. Methods: This study was conducted in the outpatient chemotherapy unit of Malatya Turgut Ozal Medical Center Oncology Hospital, Türkiye. A total of 180 patients were enrolled and randomly allocated using block randomization to an isometric exercise group (n = 60), a dry heat application group (n = 60), or a control group (n = 60). Sample size was determined through power analysis. Data were collected using the "Descriptive Information Form", "Vein Rating Scale" and "Vein Assessment Tool".

详细描述

Patients admitted to the chemotherapy unit were approached before treatment and informed about the purpose and procedures of the study. Eligibility was assessed according to the inclusion criteria, and written informed consent was obtained from all patients who met the eligibility criteria and voluntarily agreed to participate.

The data collection procedure consisted of the following steps:

Baseline assessment: Participants first completed the socio-demographic section of the Patient Information Form, and the responses were recorded by the researcher.

Pre-intervention vein assessment: A tourniquet was applied to the patient's upper extremity, and vein characteristics were assessed by the nurse using the Vein Rating Scale (VRS) and the Vein Assessment Tool (VAT). During this assessment, no manoeuvres intended to enhance vein visibility (e.g., repeated hand opening and closing, tapping, or slapping the vein) were permitted after tourniquet application. The tourniquet was then removed, and the patient rested for 10 minutes before baseline (pre-test) measurements were recorded.

Intervention: Participants received one of the study interventions according to their assigned group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

cancer patients

入排标准

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

入选标准

  • Undergoing chemotherapy treatment,
  • Receiving at least 3 cycles of chemotherapy treatment,
  • Not diagnosed with diabetes and/or without peripheral neuropathy,
  • Not receiving antithrombotic therapy,
  • Without bleeding tendency and thrombocytopenia,
  • No deep vein thrombosis,
  • No complications associated with PIVC (such as ecchymosis, hematoma, scarring, edema, infiltration, extravasation and phlebitis),
  • No allergy or sensitivity to heat,
  • No metal prosthesis in the extremity to be heat therapy applied,
  • No limb deformity that would prevent performing isometric exercises,
  • No communication problems,
  • No history of paralysis
  • Patients who volunteered to participate in the study were included.

排除标准

  • Total mastectomy,
  • With peripheral nerve disease,
  • More than 2 peripheral IV catheters applied,
  • Psychiatric illness,
  • People with intellectual disabilities at a level that cannot perceive cognitive functions and
  • Individuals who did not perform or did not want to perform the procedures applied during the research process were not included in the study.

结局指标

主要结局

Effects of isometric exercise

时间窗: Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention

Participants were provided with silicone hand exercise balls and instructed to squeeze and release the ball 15-20 times. Vein status is evaluated as the "Vein Rating scale" and the "Vein Assessment Tool". There was a visual analog scale that could be graded from 1 to 10, which evaluated the satisfaction of the nurse with the procedure and the patient's satisfaction with the previous application and the current application. The assessment of satisfaction level was performed after the IV catheter was inserted.

次要结局

  • Effects of dry heat application(Vein Rating Scale:At baseline (before the intervention) and immediately after the intervention Vein Assessment Tool:At baseline (before the intervention) and immediately after the intervention)

研究者

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

Hakime Aslan

Principal investigator

Inonu University

研究点 (1)

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