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临床试验/NCT06487520
NCT06487520已完成不适用

The Effect of Different Images Watched Wiht Virtual Reality on Perception of Pain And Anxiety During Flebotomy

Zonguldak Bulent Ecevit University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2019年4月18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
120
试验地点
2
主要终点
pain intensity in cm

研究概览

简要总结

Aim: The purpose of this study was to investigate the effect of watching a cold environment image via virtual reality on pain and anxiety related to phlebotomy procedure in volunteer blood donors.

Methods: The study was conducted between June 2019 and December 2019 with 120 healthy individuals who applied for blood donation for the first time in Northern Turkey. Individuals included in the study were assigned to intervention, placebo and control groups with 40 people in each group by block randomization method. During the phlebotomy procedure, the intervention group watched a cold environment image via virtual reality, the placebo group watched a hot environment image, and the control group received standard application. "Descriptive Characteristics Form", "Visual Comparison Scale", "State and Trait Anxiety Inventory" and The CONSORT checklist were used to collect data.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being in accordance with time and place
  • Being aged between 18 and 35 years
  • Being able to evaluate the visual analog scale correctly
  • Participating voluntarily in the research.
  • Being willing to donate blood
  • Donating blood for the first time
  • Have a body mass index within normal limits (18.5-24.9 kg/m2)
  • Have no vision or hearing problems
  • Have no disease that may affect pain perception
  • Have no vertigo, heart or lung disease
  • Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
  • Have no psychiatric disease
  • Being able to accurately assess the state and trait anxiety inventory with the VAS
  • Have an average pressure pain threshold value of 8-16 Lb obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed
  • Have no vertigo, heart or lung disease
  • Have no signs of infection, dermatitis, phlebitis, scar tissue or incision in the area where invasive intervention will be performed
  • Have no psychiatric disease
  • Being able to accurately assess the state and trait anxiety inventory with the VAS
  • Have an average pressure pain threshold value of 8-16 pounds (Lb) obtained from three measurements taken at 5-second intervals from the elbow region of the left upper extremity where no intervention was performed

排除标准

  • Not participating voluntarily in the research
  • Not fitting the inclusion criteria of the research
  • Having a vision or hearing problem
  • Failure of phlebotomy at the first attempt
  • Development of syncope after phlebotomy

结局指标

主要结局

pain intensity in cm

时间窗: 6 months

The VAS is a 100 mm (10 cm) ruler that can be used horizontally or vertically. The value of "0" at the starting level defines painlessness, and the value of "10" at the ending level defines the most severe pain. The individual marks the intensity of pain they experience on this scale. In this study, the score measurements were determined in centimeters (cm) on the VAS prepared vertically to determine the intensity of pain experienced by individuals during phlebotomy application.individuals.during the procedure. One end indicated lack of pain and the other the most.Pain intensity was evaluated in centimeters.severe pain possible. Pain severity was evaluated in millimeters.

State-Trait Anxiety Inventory (STAI) score

时间窗: 6 months

The inventory is in the form of a 4-point Likert scale, and the items in the State and Trait Anxiety Subscales are marked according to the degree of severity of the emotions and behaviors. There are ten items in the State Anxiety Scale and seven items in the Trait Anxiety Scale that contain reversed statements.

次要结局

  • Pressure pain threshold(6 months)
  • weight in kilograms(6 months)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Karaman

Associate Professor, Zonguldak Bulent Ecevit University, Ahmet Erdogan Health Services Vocational School, Health Care Services Program

Zonguldak Bulent Ecevit University

研究点 (2)

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