The Effect of Music Medicine on Anxiety and Pain Levels in Women Undergoing Embryo Transfer: 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
- 42
- 试验地点
- 1
- 主要终点
- State Anxiety Score
研究概览
简要总结
This study was designed to investigate the effects of music medicine on anxiety, pain, and vital signs in women undergoing embryo transfer. The study followed a randomized controlled design and was conducted at the IVF unit of a university hospital. The sample consisted of women who met the specified inclusion criteria, and participants were assigned to the intervention and control groups using randomization.
Data collection tools included a socio-demographic characteristics form, a vital signs recording form (blood pressure, pulse, respiratory rate, and oxygen saturation), the State-Trait Anxiety Inventory (STAI-I and II), and the Visual Analogue Scale (VAS). The intervention group listened to patient-selected music during the embryo transfer process, while the control group received standard care. Measurements were taken before, during, and after the embryo transfer.
The obtained data were analyzed using appropriate statistical methods to evaluate the effects of music on anxiety, pain levels, and vital signs. This study aims to improve women's embryo transfer experiences by contributing to nursing care and reproductive health practices.
详细描述
The study evaluates the effect of music medicine on anxiety and pain levels during embryo transfer. Participants in the intervention group listen to patient-selected music via noise-canceling headphones. The process includes baseline assessments of vital signs and anxiety, followed by post-intervention measurements 15 minutes after the 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 (Participant)
盲法说明
Randomization was performed using the sealed envelope method to ensure allocation concealment; therefore, the investigator did not know the group assignments until the point of intervention. Due to the nature of the music medicine intervention, the participants and the investigator collecting the data could not be masked during the procedure. However, to minimize bias, the statistical analysis will be conducted by a researcher blinded to the group allocations.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing embryo transfer.
- •Ages 18 to 45 years (or your specific age range).
- •Literacy in Turkish to complete the inventories.
- •Voluntarily agreeing to participate in the study.
排除标准
- •Patients with hearing impairment.
- •Patients with cognitive or psychiatric disorders that prevent completion of the inventory.
- •Patients who have taken analgesic or anxiolytic medication within the last 24 hours.
研究组 & 干预措施
Music Medicine Group
Patients in this group receive music medicine intervention in addition to standard care during the embryo transfer process.
干预措施: "Patient-Selected Music Medicine (Behavioral)
Control Group
Participants receive only the standard clinical procedures and routine care for embryo transfer without any music intervention.
结局指标
主要结局
State Anxiety Score
时间窗: Measured at two time points: baseline (pre-test, upon admission to the room) and 15 minutes after the embryo transfer procedure (post-test).
Measured using the Spielberger State-Trait Anxiety Inventory (STAI). Only the "State" subscale is used to assess the current level of anxiety related to the embryo transfer procedure. The score ranges from 20 to 80, where higher scores indicate higher levels of anxiety.
次要结局
未报告次要终点
研究者
helin kalır
PhD Candidate
Hasan Kalyoncu University