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Набор скоро начнётся NCT06776809

Effect of Music During Toe Amputation

Без фазы С лечением Amputation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Music listening.
Кому может быть актуально
Состояния в реестре: Amputation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

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.

Anxiety often begins when an individual is informed that they require surgery and tends to increase during hospitalization. This heightened anxiety can negatively impact the individual's quality of life, their ability to adapt to the illness, and the overall progression of the condition. Surgical patients, in general, are considered to be at higher risk for experiencing anxiety.

A sense of safety is an inherent human need, and it is crucial for patients to feel safe within healthcare environments. While all healthcare practices aim to ensure patient safety, it is equally important to assess whether these practices foster a sense of safety for the patient. The sense of safety experienced by patients plays a vital role in their overall health and well-being.

To date, no studies have explored the effects of music on pain, anxiety, and the sense of safety in patients before, during, or after any type of amputation. Therefore, our study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery.

Вмешательства

  • Другое Music listening
    Selection of Sufi music will be played to the patients during the course of the operation.

Первичные конечные точки

  • Numerical Rating Scale-Anxiety (NRS-A) [Срок оценки: 3 days]
  • Numerical Rating Scale-Pain (NRS-P) [Срок оценки: 3 days]
Вторичные конечные точки (2)
  • Surgical Fear Questionnaire [Срок оценки: 3 days]
  • Safety Feeling Scale [Срок оценки: 3 days]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Afyonkarahisar Health Sciences University Hospital, — Afyonkarahisar

Идентификаторы

NCT: NCT06776809 · 2024/11

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗