The Effect of Music and White Noise on Patients' Anxiety and Pain During Surgery for Impacted Mandibular Third Molar: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- PAIN VAS
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of music and whitenoise on the anxiety and pain level of patients who had impacted third molars surgery. The main questions it aims to answer are:
- Does music and white noise have an effect on the patient's intraoperative pain/pressure/discomfort?
- Does music and white noise have an effect on the patient's anxiety level?
The researchers compared the music and white noise, music-only and ambient noise groups to see if there was an effect on anxiety and pain levels.
STAI-S form was applied to all participants before surgery. They marked their anxiety levels on the VAS scale. After the procedure, STAI-S form was applied and they marked the anxiety levels on the VAS scale. The pressure/pain level which they felt during the procedure was evaluated by VAS scale.
详细描述
Our study was carried out on 66 patients, who applied to Ankara University Department of Oral and Maxillofacial Surgery, suffering from impacted mandibular third molars.
Group white noise and music listened to a preselected playlist played against a pre-prepared standard white noise through headphones that prevent ambient noise during the procedure. The playlist consisted of popular songs of the time. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.
Group music only listened to the same preselected playlist without white noise through noise-isolating headphones during the procedure. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.
Group control listened to the natural ambient noise during the procedure.
Surgical Procedure:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who applied to our clinic for impacted wisdom teeth extraction from the start date of the study
- •Patients without any diagnosed psychological disorder
- •Patients who gave their own voluntary consent to the study
- •Patients who had no medical history that could affect third molar surgery,
排除标准
- •Patients who do not agree to volunteer.
- •Patients with any diagnosed psychological disorder
- •Patients with mental and physical disorders that may hinder cooperation
- •Pregnancy or lactating,
- •Antidepressant or anxiolytic drug use, having a disease that could prevent the surgery,
- •A severe infection around the impacted third molar
- •A prior tooth extraction
研究组 & 干预措施
group music and white noise
Group music and white noise listened to a preselected playlist played against a pre-prepared standard white noise through headphones that prevent ambient noise during the procedure. The playlist consisted of popular songs of the time. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.
干预措施: music and white noise intervention (Other)
group music only
Group music listened to the same preselected playlist without white noise through noise-isolating headphones during the procedure. The patient could choose the music they wanted to listen to from the playlist using a hand-held tablet.
干预措施: music intervention (Other)
group control
Group control listened to the natural ambient noise during the procedure.
结局指标
主要结局
PAIN VAS
时间窗: perioperative
Pain measured on a VAS (Visual Analog Scale ). A closed-ended scale of 0-10 cm ("0" no anxiety, "10" maximum imaginable anxiety) was used in the study
STAI-S
时间窗: preoperative and through the surgery is over, about an hour after the patient entered the operating room
State anxiety measured on STAI-S (Spielberger State Anxiety Inventory). The total score can range from 20 to 80, with higher scores indicating more anxiety.
ANXIETY VAS
时间窗: preoperative and through the surgery is over, about an hour after the patient entered the operating room
Anxiety measured on a VAS (Visual Analog Scale). A closed-ended scale of 0-10 cm ("0" no anxiety, "10" maximum imaginable anxiety) was used in the study
次要结局
未报告次要终点
研究者
Mine ALKAYA KARAGOZ
principal Investigator
Ankara University