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Идёт набор NCT03415620

Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction

Без фазы С лечением Music Pain Anxiety Patient Satisfaction

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: Music, Pain, Anxiety, Patient Satisfaction. Базовые параметры: 21 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Use of Perioperative Music Listening on Anxiety, Pain, Analgesia Use and Patient Satisfaction in Patients Undergoing Surgery

Обзор

The use of music to relieve pain has been studied in many forms of medicines and has been proven to reduce anxiety, pain and analgesic use in the perioperative setting. However, music listening as an inexpensive and duplicable method has not been investigated and implemented in the local context. The investigators hereby propose a prospective study to recruit patients undergoing surgery to evaluate the effectiveness of music in pain relief and post-operative recovery; as well as the implementation and operational readiness of music listening.

Подробное описание

Some tissue injury is often unavoidable during surgery, which leads to unavoidable pain and anxiety during the perioperative and post-operative period. Acute post-operative pain and anxiety have been managed via pharmacological interventions. However, non-pharmacological interventions have also been shown to be safe and cost-effective, improve the overall patient experience, and improve outcomes across a variety of surgical settings.

Music has been shown to decrease perioperative pain and modulate the inflammatory response. Additionally, anxiety scores and pain scores have shown statistically significant reductions in the perioperative period, when music therapy was available. Currently only few studies investigate its effects during perioperative period especially in local setting. Thus, the investigators will investigate the feasibility and practicability of deploying music listening in KKH pain management and further determine the nature of the music (duration, genre) by fitting the local context in order to improve the patient outcome in perioperative settings.

Phase 1: A total of 300 patients will be offered to select from pre-determined lists of music of different genres or patient choice, before and after surgery. Hospital Anxiety and Depression Scale (HADS) score, pain scores, analgesia usage, patient satisfaction, and quality of life measurement will be collected. Analysis of the type of music, duration of music listening, and the genre chosen will be analysed.

Phase 2: A hundred and ten women undergoing Caesarean delivery at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of experimental (music listening) and control (no music listening) groups. Pain and psychological assessments and demographic data collection will be conducted before surgery, and those allocated to experimental group will be asked to use music listening before, during and after surgery.

Вмешательства

  • Процедура Music listening
    Patient is given an ipod with earphone and with saved playlist of different music genres. Music listening session will be given for 30 minutes before, during and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.

Первичные конечные точки

  • Change in Pain score [Срок оценки: Baseline and 1 day]
Вторичные конечные точки (5)
  • Change in Analgesia usage [Срок оценки: Baseline and 1 day]
  • Change in Patient's satisfaction with the use of music listening (only music listening group) [Срок оценки: Baseline and 1 day]
  • Change in Hospital Anxiety and Depression Scale (HADS) score (Phase 1 only) [Срок оценки: Baseline and 1 day]
  • Change in EQ-5D-3L score [Срок оценки: Baseline and 1 day]
  • Change in Visual analog scale - anxiety (VAS-A) score [Срок оценки: Baseline and 1 day]

Критерии участия

Критерии включения

  • Healthy participants who are American Society of Anesthesiologists (ASA) 1 and 2 (with well-controlled medical problems);
  • Undergo day surgery, same-day-admission gynecologic surgery or cesarean section;
  • No hearing impairment.

Критерии исключения

  • Patients with significant respiratory disease and obstructive sleep apnea;
  • Patients who are unable to read and understand the hospital anxiety questionnaire.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Сингапур · 1 центр
  • KK Women's and Children's Hospital — Singapore

Публикации

  • Kakde A, Lim MJ, Shen H, Tan HS, Tan CW, Sultana R, Sng BL. Effect of music listening on perioperative anxiety, acute pain and pain catastrophizing in women undergoing elective cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Apr 3;23(1):109. doi: 10.1186/s12871-023-02060-w. PMID 37013499

Идентификаторы

NCT: NCT03415620 · MT2017-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗