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临床试验/NCT06776809
NCT06776809尚未招募不适用

Effect of Music Listened During Toe Amputation on Patients' Anxiety, Pain, Sense of Safety and Surgical Fear

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Numerical Rating Scale-Anxiety (NRS-A)

研究概览

简要总结

This randomized controlled intervention study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.

The study will be carried out with two groups: The control and the intervention groups with 60 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music during the whole amputation procedure in addition to standard care.

详细描述

Diabetes rates are continuing to rise worldwide, leading to an increasing number of people with diabetes seeking medical care for foot wounds, with approximately 35% of diabetic individuals experiencing a foot wound at some point in their lives. Diabetic foot (DF) wounds tend to recur, with a 50% recurrence rate after treatment. Foot wounds are responsible for 85% of amputations in diabetics, and the five-year mortality rate following a lower extremity amputation rises to 77%. It is estimated that a diabetic patient undergoes an amputation every 20 seconds globally. Lower extremity amputations encompass a range of procedures, from hemipelvectomy to toe amputations. Among the most common partial amputations are those of the big toe and other toes, with diabetes being the cause of about 24% of these amputations.

A comprehensive meta-analysis examined the risk factors for amputation associated with diabetic foot ulcers and found that the overall incidence of lower extremity amputation in diabetic foot ulcer patients is 31%. This study provides crucial epidemiological data for medical practice. Key risk factors associated with lower extremity amputation include male gender, smoking history, body mass index (BMI), hypertension, cardiovascular disease, kidney disease, white blood cell count, hemoglobin, and albumin levels. Among these factors, BMI, hemoglobin, and albumin levels were negatively correlated with the likelihood of amputation, while other factors, such as gender, smoking, and comorbidities, showed positive correlations.

These findings highlight the importance of monitoring and addressing these risk factors in patients with diabetic foot ulcers to reduce the likelihood of lower extremity amputations. Consequently, targeted preventive and intervention measures focusing on these risk factors are essential in clinical practice to improve patient outcomes.

The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.

These findings underscore the importance of managing perioperative pain in patients undergoing lower extremity amputation, especially during the early postoperative period. Uncontrolled postoperative pain is one of the primary risk factors for the development of chronic pain following surgery. For amputee patients, pain, particularly in the early stages after surgery, is often accompanied by significant emotional challenges. Therefore, for comprehensive care, it is essential to consider the interplay between pain experience and the emotional well-being of patients who have not received adequate pain management.The literature reveals that pain following lower extremity amputation is widespread and remains a significant factor affecting patients' quality of life. If not properly managed, this post-amputation pain can have detrimental consequences for the patient. Effective pain control during the perioperative period has been shown to help prevent chronic stump pain, highlighting the importance of intraoperative anesthesia management and postoperative acute pain control. These factors influence the body's stress response to surgery and have a direct impact on recovery, discharge, and the return to daily activities. This is particularly critical for amputation patients, as early mobilization plays a key role in both physical and psychological recovery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •18 years of age or above,
  • •Having a toe amputation under spinal anesthesia due to diabetic foot,
  • •Without hearing/speech impairment,
  • •Without a diagnosis of psychiatric disorders,
  • •Without any professional training in music,
  • •and volunteered to participate.

排除标准

  • •Patients under 18 years of age,
  • •With hearing/speech impairment,
  • •With a diagnosis of psychiatric disorders,
  • •With any kind of professional training in music,
  • •and not willing to participate in the study.

研究组 & 干预措施

Control Group

No Intervention

Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic.

Intervention Group- Listening to Sufi Music

Experimental

Patients in this group will listen to Sufi music during toe amputation in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones throughout the operation. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient.

干预措施: Music listening (Other)

结局指标

主要结局

Numerical Rating Scale-Anxiety (NRS-A)

时间窗: 3 days

The Numerical Rating Scale-Anxiety (NRS-A) has been widely used in research to assess anxiety levels, with its reliability and validity well-established. This scale, which ranges from 0 to 10, measures anxiety from "No Stress" (0) to "Very Bad Stress" (10). A higher score indicates a greater level of anxiety. The scale categorizes raw anxiety scores as follows: 0-no anxiety, 1-3-slightly anxious, 4-6-moderately anxious, 7-9-very or extremely anxious, and 10-the worst imaginable or extremely anxious.

Numerical Rating Scale-Pain (NRS-P)

时间窗: 3 days

The Numerical Rating Scale-Pain (NRS-P) is a one-dimensional tool that uses 11 numbers, ranging from 0 to 10, to assess pain intensity. The patient selects the number that most accurately reflects the severity of their pain, with 0 representing "no pain" and 10 indicating "the worst (unbearable) pain". The NRS-P is widely recognized as an effective method for measuring pain intensity, and it is generally considered more valid and reliable than other pain assessment scales.

次要结局

  • Surgical Fear Questionnaire(3 days)
  • Safety Feeling Scale(3 days)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Ciğerci

Assoc.Prof.

Afyonkarahisar Health Sciences University

研究点 (1)

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