Effects of White and Pink Noise Applied Before and During Colonoscopy on Pain and Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Visual Anxiety Scale (VAS-A)
研究概览
简要总结
In recent years, there has been an increase in the use of endoscopic procedures due to the increase in diseases. Colonoscopy is widely used in the screening and diagnosis of many diseases, especially colorectal cancer. However, colonoscopy is perceived as an invasive, painful and uncomfortable procedure by patients. Moreover, it can cause pain associated with embarrassment, fear, anxiety and physical and emotional discomfort.
详细描述
This study aims to evaluate the effects of white and pink noise applied before and during colonoscopy on pain and anxiety levels of patients. Colonoscopy is a widely used method in colon cancer screening and diagnosis and treatment of lower gastrointestinal system diseases; however, pain may occur in patients due to mesenteric distension and spasms during the procedure. In addition, many patients experience moderate anxiety during the procedure. Since pharmacological pain and anxiety management strategies may lead to some complications, in recent years, there has been an increase in the use of non-pharmacological methods such as music, video, virtual reality and distraction techniques. One of these methods, sound therapy, provides relaxation by directing the individual's attention to positive emotions. While white noise is a constant-intensity sound similar to the sound of the ocean or wind, pink noise resembles rain or rustling leaves with its lower frequency and soothing properties. There are a limited number of studies in the literature examining the effects of white and pink noise, but there is no study evaluating both types of noise together in colonoscopy patients. In order to fill this gap, the effects of white and pink noise on pain and anxiety are comparatively examined in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Investigator)
盲法说明
The statistical analysis was performed by an independent statistician who was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteering to participate in the study,
- •Being over 18 years old,
- •The patient should not have a hearing and visual problem,
- •Being conscious, oriented and cooperative
排除标准
- •The patient's use of anxiolytics or analgesics on the day of the procedure,
- •The patient's diagnosis of any psychiatric / neurological disease,
- •The patient's preference for general anesthesia will be considered as exclusion criteria.
研究组 & 干预措施
Pink noise
In addition to the standard care protocol, the patients included in this group will listen to pink noise through headphones as directed by the researcher. Pink noise is a sound form that is dominated by low-frequency sounds and provides a more natural, soft acoustic environment. Sounds similar to sounds in nature (e.g. wind, rain, ocean waves) are included as pink noise. The patient will listen to pink noise through headphones for 20 minutes before the colonoscopy begins. It will be administered for 20 minutes during the procedure. During the procedure, pain will be assessed with VAS and anxiety levels will be assessed with VAS-A. The sound level will be maintained at a safe level. After the colonoscopy, patient will be transferred to the observation area and rest for 30 minutes.
干预措施: PNG (Behavioral)
Control group
Patients in the control group will only be subject to the hospital's current standard care protocol. The procedures performed within the scope of this protocol include routine practices such as informing the patient, making the necessary medical preparations, and providing basic nursing interventions during the procedure. After the colonoscopy procedure is completed, the patient will be taken out of the endoscopy room and taken to the rest area where they will rest for 30 minutes in a quiet environment. At the end of this period, the VAS and VAS-A forms will be filled in again by the researcher and post-procedure pain and anxiety levels will be measured.
white noise
In this group, patients will listen to white noise via headphones in addition to the hospital's standard care protocol prior to and during the colonoscopy procedure, as directed by the researcher. White noise is a type of sound that contains equal intensity sound across the entire frequency spectrum and suppresses environmental sounds that distract the individual by masking external noise. The patient will listen to the noise via headphones for 20 minutes before the colonoscopy begins. It will be administered for 20 minutes during the procedure, and pain will be assessed with VAS and anxiety levels will be assessed with VAS-A during the procedure. The sound level will be adjusted to predetermined safe levels so as not to disrupt the patient's comfort. At the end of the 30-minute observation period, pain and anxiety levels will be reassessed using the VAS and VAS-A.
干预措施: WNG (Behavioral)
结局指标
主要结局
Visual Anxiety Scale (VAS-A)
时间窗: Before colonoscopy (baseline), during colonoscopy immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy
VAS-A is a single-item measurement tool that has been used for psychological assessment since the beginning of the 20th century. It is frequently used in the assessment of pain, quality of life and mood. It was developed by "Cline et al" (1992) and is extremely simple, reproducible and requires minimal tools. The scale consists of a 10 cm long horizontal line with the labels "No anxiety" on the left and "I feel a lot of anxiety" on the right. The patient's anxiety level is calculated by measuring the distance between the leftmost part of the scale and the specified point. As the anxiety level approaches 10, anxiety increases.
The Visual Analog Scale (VAS)
时间窗: During colonoscopy, immediately after the 20-minute auditory intervention, and 30 minutes after colonoscopy
The Visual Analog Scale (VAS) is a single-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores obtained from the scale indicate high pain intensity. The cut-off points for pain scores obtained from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain".
Visual Anxiety Scale (VAS-A)
时间窗: before colonoscopy 10 minutes
VAS-A is a single-item measurement tool that has been used for psychological assessment since the beginning of the 20th century. It is frequently used in the assessment of pain, quality of life and mood. It was developed by "Cline et al" (1992) and is extremely simple, reproducible and requires minimal tools. The scale consists of a 10 cm long horizontal line with the labels "No anxiety" on the left and "I feel a lot of anxiety" on the right. The patient's anxiety level is calculated by measuring the distance between the leftmost part of the scale and the specified point. As the anxiety level approaches 10, anxiety increases.
The Visual Analog Scale (VAS)
时间窗: before colonoscopy 10 minutes
The Visual Analog Scale (VAS) is a single-dimensional scale commonly used to measure pain intensity. VAS is a measuring tool with a length of 0-10 cm (0-100 mm). This measuring tool can be used horizontally or vertically. The scale starts with "no pain" and ends with "unbearable pain". High scores obtained from the scale indicate high pain intensity. The cut-off points for pain scores obtained from the scale are recommended as 0-4 mm "no pain", 5-44 mm "mild pain", 45-74 mm "moderate pain" and 75-100 mm "severe pain".
次要结局
未报告次要终点
研究者
Seda Cansu Yeniğün
Lecturer Dr
Akdeniz University