跳至主要内容
临床试验/NCT06969105
NCT06969105招募中不适用

A Randomized Controlled Trial of Music Use in Parturients Admitted to Labor & Delivery

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年5月30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
入组人数
106
试验地点
2
主要终点
Anxiety

研究概览

简要总结

The goal of this clinical trial is to learn if music use affects anxiety or pain levels in parturients admitted to labor and delivery. It will also learn about the effect of music use on patient satisfaction. The main questions it aims to answer are:

Does music use affect anxiety levels in parturients admitted to labor and delivery? Does music use affect pain levels in parturients admitted to labor and delivery? Does music use affect patient satisfaction in parturients admitted to labor and delivery?

Researchers will compare music to a control (no music) to see if music affects anxiety levels in parturients admitted to labor and delivery.

Participants will:

Listen to music or listen to no music for a 10 minute duration in the labor and delivery unit.

Answer questions about anxiety and pain levels at a few different timepoints. Have information collected from medical charts (vital signs and cervical dilation).

Rate their satisfaction with care.

详细描述

Subjects will be asked their preferred music choice before they are randomly assigned to either the intervention music group, or the no music control group.

The study's active intervention group will be listening to the subject's preferred music for a duration of 10 minutes. The subjects will listen to their preferred music choice played from a speaker connected to an audio device, both supplied by the research team. The investigator and the patient will collaborate on patient positioning of the audio device for sound to optimize comfort and safety during the study intervention. Researchers will confirm the volume of the music and assess subject's comfort before leaving the room for 10 minutes while they listen to music. Subjects must turn off all other noises such as television, other music being played, phone calls ringer/vibration, and texting notifications will be turned off prior to initiation of the study. Phone calls and texting may be left on for subject's who request this. The study team will wait outside the door for 10 minutes, before re-entering. Nursing and providers essential to care will be notified that the subject is participating in the study to ensure no one enters the room unless medically necessary or in case of emergency during this 10-minute time period.

The Control group will not listen to music. The study team will still leave the room for 10 minutes and then re-enter to continue collecting data at each of the time points as below:

Before the intervention begins, researchers will collect from all parturient subjects' their anxiety score (on a scale of 0-10, with 0 being no anxiety), ask them to complete the STAI questionnaires on paper to collect their scores (submitted) and pain score, and record the time data was collected. Researchers will also record clinical data from the EMR for the parturient subject or ask the nurses for the data at the time they take these readings (see Data Collection Form).

If parturient subjects request labor analgesia and have an epidural catheter placed, researchers will collect the same data from parturient subjects both at the time that the request is made and within 30 minutes of the catheter being placed. The data collected from these two timepoints is an optional component of the study (see Informed Consent Form). The subjects can consent ahead of time in the ICF but may withdraw consent for these 2 data points and still be in the rest of the study as the data collected at these 2 timepoints are secondary objectives to explore. If a member of the research team is not in the room at the time this happens, researchers will not collect Anxiety, STAI or pain score and will only collect what is available from the charts, as per the Data Collection Form.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age: 18 years or older
  • •Laboring parturients or those scheduled for an induction of labor
  • •Able to provide informed consent
  • •American Society of Anesthesiologists (ASA) physical status rating of II-III

排除标准

  • •Patient refusal
  • •Impaired hearing
  • •Patient is taking at least one anxiolytic medication daily at baseline
  • •Intrauterine fetal demise
  • •Severe psychiatric disorder

研究组 & 干预措施

Music Group

Experimental

Subjects randomized to this arm will listen to music for a 10 minute duration.

干预措施: Music (Other)

Control Group

No Intervention

Subjects randomized to this arm will not listen to music for a 10 minute duration.

结局指标

主要结局

Anxiety

时间窗: Baseline and 0 hours post-intervention

Anxiety will be assessed in two ways. The first using a 0-10 numeric rating scale in which subjects rate their self-perceived anxiety level on this scale. Secondly, they will answer survey questions on the State-Trait Anxiety Inventory questionnaire.

次要结局

  • Pain Level(Request of labor analgesia and 0,1 hours post-epidural catheter placement)
  • Patient Satisfaction(0 hours post-intervention)
  • Anxiety(Request of labor analgesia and 0,1 hour post-epidural catheter placement)
  • Blood Pressure(Baseline to 0 hours post-intervention)
  • Heart Rate(Baseline to 0 hours post-intervention)
  • Oxygen Saturation(Baseline to 0 hours post-intervention)
  • Pain Level(Baseline to 0 hours post-intervention)
  • Blood Pressure(Request of labor analgesia and 0,1 hours post-epidural catheter placement)
  • Heart Rate(Request of labor analgesia and 0,1 hours post-epidural catheter placement)
  • Oxygen Saturation(Request of labor analgesia and 0,1 hours post-epidural catheter placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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