Effect of Music on Anxiety Levels During Intrauterine Device Application: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anxiety severity
研究概览
简要总结
This study was conducted as a pre-test/post-test, randomized controlled trial to evaluate the effect of music on anxiety levels of women undergoing intrauterine device (IUD) insertion. Data were collected between January 2025 and May 2025 at a Community Health Center in Bingöl province. A total of 60 women (30 in the experimental group, 30 in the control group) who applied for IUD insertion were included. Women in the experimental group listened to slow classical music (12-15 beats per minute) through headphones for approximately 20 minutes prior to the procedure and continued listening during the procedure, totaling 30 minutes. Women in the control group did not listen to music. Anxiety levels were assessed before and after the procedure using the State-Trait Anxiety Inventory-State (STAI-S) Scale. Institutional and ethics committee approvals, as well as informed consent, were obtained before the study.
详细描述
This randomized controlled study aimed to assess the effect of music on procedural anxiety in women undergoing IUD insertion. Randomization was performed using a computer-generated random number table prepared by a statistician. Each participant meeting the inclusion criteria was assigned to either the experimental or control group via opaque envelopes distributed in the order of clinic admission. The independent variable was music listening, and the dependent variable was anxiety level measured using the STAI-S Scale. Data were collected from women at a Community Health Center between January and May 2025. The study received ethical approval and informed consent was obtained from all participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who will have an IUD for the first time
- •Women aged 18-45
排除标准
- •Women with hearing problems
- •Women with psychiatric diagnoses
研究组 & 干预措施
Music Listening with Binaural Beats
Participants in the experimental group will listen to instrumental music embedded with 7 Hz binaural beats (theta range) generated using Gnaural (GPL-2.0 licensed, programmable sound generator). The tracks include piano and instrumental music played at a volume of 50-60 dB, allowing communication with the healthcare provider. Music will be delivered via headphones for approximately 30 minutes (20 minutes before and during the procedure). STAI-I and STAI-II scores will be assessed pre- and post-procedure.
干预措施: Music Listening (Binaural Beats via Gnaural) (Behavioral)
Routine Care Without Music
Participants in the control group will receive standard care during IUD insertion. No music or other additional intervention will be applied. STAI-I and STAI-II scores will be measured before and after the procedure.
结局指标
主要结局
Anxiety severity
时间窗: Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure)
Anxiety severity will be measured using the State Anxiety subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S). Participants will respond to 20 items using a 4-point Likert scale (1 = Not at all, 2 = Somewhat, 3 = Moderately so, 4 = Very much so).
次要结局
- Trait Anxiety Severity(Baseline (immediately before the IUD procedure) and Post-Procedure (within 30 minutes after the IUD procedure))
研究者
Şükriye ŞAHİN
Research Assistant Doctor
Kocaeli University