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临床试验/NCT07171008
NCT07171008招募中不适用

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

Niran Çoban1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
The Effect of Ney Music on Pain

研究概览

简要总结

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.

详细描述

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)

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Ney Music

Experimental

Participants in this group will receive a 15-minute ney performance in addition to routine nursing care at specified times before and after lumbar disc surgery. The intervention will be carried out in three sessions:

I. Session: On the day of surgery, before surgery

II. Session: Within the first 3 hours after surgery (after transfer to the clinic)

Session III: Morning of the first day after surgery

Before and after the application, the Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Scale, and vital signs (blood pressure, pulse, oxygen saturation) will be measured. Ney pieces in the Rast and Nihavent modes will be used in the sessions.

干预措施: Ney music (Other)

Standard care

No Intervention

Only standard nursing care will be provided to participants in this group. Parallel to the timing in the intervention group, VAS, STAI-I, Richard-Campbell Sleep Scale, and vital signs will be measured at three separate times (pre-surgery, first 3 hours post-surgery, and first day post-surgery), but no music will be played.

结局指标

主要结局

The Effect of Ney Music on Pain

时间窗: 6 month

Visual Analog Scale: The Visual Analog Scale is a commonly used unidimensional measure for assessing pain intensity. The VAS is a measurement tool ranging from 0 to 10 cm (0 to 100 mm) in length. Since the aim of the study is to determine the effect of the non-pharmacological method used on the current pain, the VAS will be used in the assessment of pain before and after application. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

The Effect Ney Music on Anxiety

时间窗: 6 month

State Anxiety Inventory: In our study, the State Anxiety Inventory will be used before and after the procedure to assess patients' anxiety levels in a specific situation. The State Anxiety Inventory (STAI-I) is a tool that measures how an individual feels at a specific moment and in a specific situation, i.e., their anxiety level in that situation.Each subscale consists of 20 items, and the inventory consists of a total of 40 items. When calculating the State Anxiety Inventory, the scoring is reversed for items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score from both scales in the inventory ranges from 20 to 80. High scores on the scales indicate high anxiety, while low scores indicate low anxiety levels. Measurements will be taken at the following intervals: On the day of surgery, before surgery;Three hours after surgery (after transfer to the clinic); On the morning of the first day after surgery

The Effect Ney Music on Sleep

时间窗: 6 month

Richard-Campbell Sleep Scale: Assesses the depth of nighttime sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake after waking up, the quality of sleep, and the noise level in the environment. Each item is rated on a scale ranging from 0 to 100 using the Visual Analog Scale technique. A score between "0-25" on the scale indicates very poor sleep, while a score between "76-100" indicates very good sleep. The total scale score is evaluated based on five items, excluding the 6th item, which assesses the noise level in the environment, with a total score of 22. As the scale score increases, patients' sleep quality also improves. It will be used to evaluate the effect of non-pharmacological interventions on patients' sleep levels after surgery. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

The Effect Ney Music on blood pressure

时间窗: 6 month

Patients' blood pressure, values will be recorded. The effect of non-pharmacological interventions on patients' blood pressure values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

The Effect Ney Music on pulse

时间窗: 6 month

Patients' pulse , values will be recorded. The effect of non-pharmacological interventions on patients' pulse values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

The Effect Ney Music on oxygen saturation

时间窗: 6 month

Patients' oxygen saturation , values will be recorded. The effect of non-pharmacological interventions on patients' oxygen saturation values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

次要结局

未报告次要终点

研究者

发起方
Niran Çoban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Niran Çoban

Asst.Prof.

University of Yalova

研究点 (1)

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