Clinical trial NCT06969105: Music Use in Parturients Admitted to Labor & Delivery
Official title: A Randomized Controlled Trial of Music Use in Parturients Admitted to Labor & Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Patient Satisfaction
Keywords: music
labor and delivery
parturients
anxiety
analgesia
anesthesia
pain
epidural
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will listen to music (intervention) and the other group will not listen to music (control).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

After the intervention (or time has passed, if they are in the control group), the same information will be collected from all participants a second time (see Data Collection Form). Parturient satisfaction will be recorded (Data Collection Form). Nurses on the subject's normal care team will be asked to assist with collecting the vitals for the data collection forms.

All procedures are occurring for research purposes only. Initial vitals collected will be done as per standard care and data will only be pulled later from charts or researchers will ask the nurses for the information as they are collecting it. Later vitals collected, if done at a time where they are not being collected for standard care, will be collected for research only - by the standard care team nurses.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Anxiety
timeFrame: Baseline and 0 hours post-intervention
Secondary outcomes:
measure: Pain Level
timeFrame: Baseline to 0 hours post-intervention
measure: Patient Satisfaction
timeFrame: 0 hours post-intervention
measure: Anxiety
timeFrame: Request of labor analgesia and 0,1 hour post-epidural catheter placement
measure: Pain Level
timeFrame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
measure: Blood Pressure
timeFrame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
measure: Heart Rate
timeFrame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
measure: Oxygen Saturation
timeFrame: Request of labor analgesia and 0,1 hours post-epidural catheter placement
measure: Blood Pressure
timeFrame: Baseline to 0 hours post-intervention
measure: Oxygen Saturation
timeFrame: Baseline to 0 hours post-intervention
measure: Heart Rate
timeFrame: Baseline to 0 hours post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
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citation: Fong TM, Drzymalski DM. The 95% Effective Duration of Music for Anxiolysis Before Elective Cesarean Delivery. A A Pract. 2025 Feb 28;19(3):e01931. doi: 10.1213/XAA.0000000000001931. eCollection 2025 Mar 1.
citation: Drzymalski DM, Tsen LC, Palanisamy A, Zhou J, Huang CC, Kodali BS. A Randomized Controlled Trial of Music Use During Epidural Catheter Placement on Laboring Parturient Anxiety, Pain, and Satisfaction. Anesth Analg. 2017 Feb;124(2):542-547. doi: 10.1213/ANE.0000000000001656.