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临床试验/NCT07590869
NCT07590869已完成不适用

The Effect of Using a Stress Ball Accompanied by Music During a Colonoscopy on Pain, Anxiety, and Perception of the Procedure

Inonu University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Visual Analog Scale (VAS)

研究概览

简要总结

This study aims to evaluate whether using a stress ball together with listening to music during a colonoscopy procedure can reduce patients' pain and anxiety and improve their overall experience of the procedure. Colonoscopy is an important method for diagnosing and preventing colorectal diseases, but it can often cause discomfort, pain, and anxiety in patients.

In this randomized controlled study, 100 patients undergoing colonoscopy without sedation are divided into two groups. One group receives the intervention, which includes listening to relaxing music and using a stress ball starting before the procedure and continuing throughout it. The other group receives standard care without any additional intervention.

Pain levels, anxiety levels, and patients' perceptions of the procedure are measured before and after the colonoscopy using validated assessment tools. Patient satisfaction with the intervention is also evaluated.

The study investigates whether simple, low-cost, and non-invasive methods such as music and stress ball use can improve patient comfort and experience during colonoscopy. The findings may help healthcare providers, especially nurses, to enhance patient-centered care practices.

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 (Participant)

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

  • Patients undergoing outpatient colonoscopy
  • Aged 18 years and older
  • Conscious and able to communicate
  • No hearing or communication problems
  • No psychiatric disorders
  • Scheduled for colonoscopy without sedation
  • Not using anxiolytic medication
  • Willing to participate and provide written informed consent

排除标准

  • Hospitalized patients undergoing colonoscopy
  • Patients with upper extremity dysfunction, neuromuscular disorders, or conditions preventing effective use of a stress ball (e.g., pain, injury, infection, immobilization)
  • Patients with sensory impairments
  • Patients undergoing gastroscopy
  • Patients undergoing colonoscopy with deep sedation
  • Patients with chronic pain or anxiety disorders
  • Patients using any other complementary or alternative methods during the study
  • Incomplete questionnaire data
  • Refusal to participate

研究组 & 干预措施

experimental group

Experimental

Patients in the experimental group were given stress balls while listening to music

干预措施: Music and Stress Ball Intervention (Other)

control group

No Intervention

Patients in the control group were not given stress balls accompanied by music

结局指标

主要结局

Visual Analog Scale (VAS)

时间窗: 15 minutes before colonoscopy

Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain intensity.

State-Trait Anxiety Scale (STAI-S)

时间窗: 15 minutes before colonoscopy

Anxiety levels were assessed using the State Anxiety Scale of the State-Trait Anxiety Inventory (STAI-S), a 20-item self-report instrument with scores ranging from 20 to 80. Higher scores indicate higher levels of situational anxiety.

Perception of Colonoscopy Procedure

时间窗: 15 minutes before colonoscopy

Patients' perceptions of the colonoscopy procedure were evaluated using a structured questionnaire assessing perceived difficulty, duration, tolerability, and emotional responses before and after the procedure.

次要结局

  • Visual Analog Scale (VAS)(5 minutes after the colonoscopy)
  • State-Trait Anxiety Scale(5 minutes after the colonoscopy)
  • Perception of Colonoscopy Procedure(immediately after the colonoscopy)

研究者

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

Muhammed Gönültaş

Nurse

Inonu University

研究点 (1)

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