Music Use in Parturients Admitted to Labor & Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTufts Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Patient refusal
Impaired hearing
Patient is taking at least one anxiolytic medication daily at baseline
Intrauterine fetal demise
Trial design
Design model
Parallel
Treatments tested in this trial
Music
Other interventionPrior to randomization, all participants will pre-select their preferred music genre. If randomized to the music group, their preferred music genre will be played for a 10 minute duration.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Music GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety
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.
Time frame
Baseline and 0 hours post-interventionSecondary outcomes
1
Pain Level
Pain will be assessed on a 0-10 numeric rating scale in which subjects rate their self-perceived level of pain.
Time frame
Baseline to 0 hours post-intervention2
Patient Satisfaction
Patient satisfaction will be assessed using a survey question asking how satisfied the patient is with their care. Subject will rate their satisfaction level as very poor, somewhat poor, average, satisfied, or very satisfied.
Time frame
0 hours post-intervention3
Anxiety
Anxiety levels will be assessed using a 0-10 numerical rating scale and on the State Trait Anxiety Inventory questionnaire. Subject will rate their self-perceived anxiety level and answer survey questions.
Time frame
Request of labor analgesia and 0,1 hour post-epidural catheter placement4
Pain Level
Pain will be assessed using a 0-10 numerical rating scale. Subject will rate their self-perceived pain level on this scale.
Time frame
Request of labor analgesia and 0,1 hours post-epidural catheter placementSponsors and contacts
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Source ClinicalTrials.gov