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临床试验/NCT07676422
NCT07676422招募中不适用

The Effect of a Stress Ball on Pain, Anxiety, and Stress During Oral Care Procedures: A Randomized Controlled Experimental Study

Yuzuncu Yil University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
Stress level

研究概览

简要总结

This study aims to evaluate the effect of using stress balls during oral care procedures performed on conscious patients in the intensive care unit on patients' pain, anxiety, and stress levels.

详细描述

This study aims to evaluate the effect of using a stress ball during oral care procedures on pain, anxiety, and stress levels in conscious patients in the intensive care unit. Individuals meeting the inclusion criteria and voluntarily agreeing to participate in the study were randomly assigned to groups. Pre-test forms will be administered. The stress ball group will be given a stress ball by the researcher before oral care and will be asked to focus on and squeeze the ball for 15-20 minutes during oral care. The control group will continue with routine treatment and care; no additional intervention will be applied. Post-test measurements will be evaluated after oral care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The Investigator and Outcomes Assessor will not know the experimental and control groups during the data collection and evaluation phases. The groups will be coded.

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

  • Being 18 years of age or older,
  • Being conscious and able to communicate,
  • Having an indication for oral care application,
  • Agreeing to participate in the study voluntarily.

排除标准

  • Being under heavy sedation,
  • Those with limited upper extremity movement,
  • Those with severe neurological disorders,
  • Having any problem with squeezing a ball in their hand (wound, fracture, weakness)
  • Termination Criteria:
  • Those who wish to withdraw from the study,
  • Those who change institutions/city,
  • The study will be terminated in the event of the patient's death.

结局指标

主要结局

Stress level

时间窗: periprocedural

A distress thermometer will determine the stress level using numbers from 0 to 10 on its scale.

次要结局

  • Pain level(periprocedural)

研究者

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

Yavuz Uren

Asst. Prof.

Yuzuncu Yil University

研究点 (1)

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