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Идёт набор NCT07171008

The Effect of Ney Music on Patients Undergoing Lumbar Disc Surgery

Без фазы С лечением Lumbar Disc Herniation Surgery Nurse's Role

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: Ney music.
Кому может быть актуально
Состояния в реестре: Lumbar Disc Herniation, Surgery, Nurse's Role. Базовые параметры: 18 лет — 70 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

The Effect of Ney Music on Pain, Anxiety, Sleep, and Quality of Life in Patients Undergoing Lumbar Disc Surgery

Обзор

This randomized controlled study aims to investigate the effects of ney music listening, a traditional Turkish wind instrument, on pain, anxiety, sleep quality, and vital signs in patients undergoing lumbar disc herniation surgery. Participants will be randomly assigned to intervention and control groups. The intervention group will receive a 15-minute ney music session at three different time points: preoperative (on the day of surgery), postoperative 3rd hour, and postoperative day 1. The control group will receive standard postoperative nursing care without music intervention. Data will be collected at the same time points in both groups using the Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Questionnaire, and vital signs. The study seeks to evaluate the non-pharmacological benefits of therapeutic music in postoperative recovery.

Подробное описание

Lumbar disc herniation is a common spinal disorder that often requires surgical intervention when conservative treatments fail. Although surgery can alleviate nerve compression and reduce pain, many patients continue to experience postoperative pain, anxiety, sleep disturbances, and altered physiological parameters, all of which negatively impact recovery. For this reason, complementary approaches such as therapeutic music have gained attention as supportive strategies in postoperative care.

This randomized controlled trial is designed to evaluate the effect of ney music listening, a traditional Turkish musical practice, on postoperative pain, anxiety, sleep quality, and physiological parameters (heart rate, blood pressure, and oxygen saturation) in patients undergoing lumbar disc surgery. The ney, a reed flute used in classical Turkish music, has been associated with calming and meditative effects, potentially supporting recovery processes.

The intervention group will listen to recorded ney music for 15 minutes in a quiet and dimly lit environment via headphones. The music selection will consist of instrumental compositions in Rast and Nihavend maqams, known for their soothing and relaxing tonalities. Sessions will occur at three specific time points:

Preoperative (the evening before surgery)

Postoperative 3rd hour (after transfer to the clinic)

Postoperative Day 1 (before bedtime)

In each session, pain (measured with the Visual Analog Scale - VAS), anxiety (measured with the State-Trait Anxiety Inventory-I), sleep quality (Richard-Campbell Sleep Questionnaire), and vital signs (systolic and diastolic blood pressure, pulse, and SpO₂) will be assessed before and after music listening in the intervention group.

The control group will receive routine postoperative care without any music intervention. However, outcome measurements will be collected at the same intervals and using the same tools to enable comparison.

The study hypothesizes that listening to ney music may serve as an effective, non-pharmacological method to enhance postoperative comfort by reducing pain and anxiety, stabilizing physiological parameters, and improving sleep quality. The results are expected to contribute to the growing body of evidence supporting the integration of music therapy into clinical nursing practice, particularly in surgical settings.

Вмешательства

  • Другое Ney music
    Ney music concert

Первичные конечные точки

  • The Effect of Ney Music on Pain [Срок оценки: 6 month]
  • The Effect Ney Music on Anxiety [Срок оценки: 6 month]
  • The Effect Ney Music on Sleep [Срок оценки: 6 month]
  • The Effect Ney Music on blood pressure [Срок оценки: 6 month]
  • The Effect Ney Music on pulse [Срок оценки: 6 month]
  • The Effect Ney Music on oxygen saturation [Срок оценки: 6 month]

Критерии участия

Критерии включения

  • Having undergone lumbar disc surgery under general anesthesia
  • 18 years old and over,
  • At least 3 hours have passed from the analgesic administration,
  • Patients willing to participate in the study will be included in the study.

Критерии исключения

  • Patient-controlled analgesia (PCA) is applied,
  • Over 70 years old,
  • Using anxiolytic and sedative drugs,
  • Having a psychiatric illness,
  • Patients with communication barriers will not be included in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

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

Центры проведения

Turkey (Türkiye) · 1 центр
  • Niran Çoban — Yalova

Публикации

  • Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491. PMID 30280915
  • Erdal, B., Kındap Tepe, Y., Öztürk, O. M., Çiğdem, B., Erol, T., Bulut, M. H., et al. (2022). Tarihi Türk müziği makamlarının fizyolojik ve psikolojik etkileri üzerine bir araştırma. Türk Dünyası Sosyal Bilimler Sempozyumu Tam Metin Kitabı. İzmir.
  • Doğan, H. D. (2022). Klasik Türk müziği makamları uygulanarak yapılan hemşirelik doktora tezlerinin değişkenler açısından sistematik incelenmesi. Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi ve Folklorik Tıp Dergisi, 12(3), 610-627.
  • Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14. PMID 29248604
  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Ho PMID 22588748
  • Karaman, Ö. Z., Özer, N. (2015). Richard-Campbell Uyku Ölçeği geçerlik ve güvenilirlik çalışması. Türk Uyku Tıbbi Dergisi, 2, 29-32.
  • Leonard H. Live Music Therapy During Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. J Music Ther. 2019 Feb 16;56(1):61-89. doi: 10.1093/jmt/thy022. PMID 30770536
  • Lin LW, Weng SC, Wu HS, Tsai LJ, Lin YL, Yeh SH. The Effects of White Noise on Agitated Behaviors, Mental Status, and Activities of Daily Living in Older Adults With Dementia. J Nurs Res. 2018 Feb;26(1):2-9. doi: 10.1097/JNR.0000000000000211. PMID 29315202

Идентификаторы

NCT: NCT07171008 · NS*

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗