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临床试验/NCT06669338
NCT06669338已完成不适用

The Effect of Music Therapy and White Noise on Pre-procedural Fear, Anxiety and Vital Signs of Elderly Colonoscopy Patients: A Double-Blind Randomized Controlled Trial

Muğla Sıtkı Koçman University3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月25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
90
试验地点
3
主要终点
respiratory rate

研究概览

简要总结

The aim of the study was to examine the effect of two different interventions (music therapy and white noise listening) on anxiety, fear and vital signs in elderly patients undergoing colonoscopy.

The study was a double-blind, pre-test and post-test

详细描述

Colonoscopy patients experience high levels of fear and anxiety due to the procedure. Fear and anxiety can activate the patient's autonomic nervous system, leading to increased sweating, increased heart rate, blood pressure and respiratory rate, and procedure-related complications. Reducing fear and anxiety and relaxing the patient not only prevents potential harm to the patient due to the procedure, but also facilitates the work of the healthcare team performing the procedure and ensures accurate results. In this context, this study aimed to investigate the effects of music therapy and white noise listening on the fear, anxiety and vital signs of patients undergoing colonoscopy.

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
Double (Investigator, Outcomes Assessor)

盲法说明

results evaluator

入排标准

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

入选标准

  • The one to be colonoscoped,
  • 65 years of age or older,
  • Participated in the research voluntarily
  • No vision, hearing and perception problems,
  • No communication problems (able to speak Turkish),
  • Those who are hemodynamically stable before colonoscopy,
  • No psychiatric diagnosis, no use of antidepressants, anxiolytics and sedative agents,
  • No analgesic or anesthetic medication 24 hours before the procedure.

排除标准

  • Developing complications during the procedure,
  • Removing the headset during the procedure,
  • Participants with visual and hearing impairment or a medical history of dementia, cognitive impairments or psychiatric disorders
  • The general condition deteriorated during the procedure or a different intervention was performed with anesthesia,
  • Who wants to leave the study on their own accord.

结局指标

主要结局

respiratory rate

时间窗: 20 minutes of music therapy, white noise and ambient sound before colonoscopy.

Measurements are made at the beginning and end of the music therapy, white noise and ambient sound listening intervention before colonoscopy.

次要结局

  • diastolic blood pressure(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • Visual Analog Scale (VAS)(20 minutes of music therapy, white noise and ambient sound before a colonoscopy.)
  • The State-Trait Anxiety Inventory (STAI-I)(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • heart rate(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • SpO2: peripheral oxygen saturation (%)(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)
  • systolic blood pressure(20 minutes of music therapy, white noise and ambient sound before colonoscopy.)

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehtap Cullu

Phd lecturer

Muğla Sıtkı Koçman University

研究点 (3)

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