Music Use in Parturients Admitted to Labor & Delivery

NCT06969105 | Recruiting

• 1 other identifier: STUDY00005897
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Patient Satisfaction

Keywords

music; labor and delivery; parturients; anxiety; analgesia; anesthesia; pain; epidural

Outcome Measures

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.

  Baseline and 0 hours post-intervention

Secondary Outcomes (10)

• Pain Level

  Baseline to 0 hours post-intervention

• Patient Satisfaction

  0 hours post-intervention

• Anxiety

  Request of labor analgesia and 0,1 hour post-epidural catheter placement

• Pain Level

  Request of labor analgesia and 0,1 hours post-epidural catheter placement

• Blood Pressure

  Request of labor analgesia and 0,1 hours post-epidural catheter placement

Study Arms (2)

Music Group

EXPERIMENTAL

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

Other: Music

Control Group

NO INTERVENTION

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

Interventions

Music OTHER

Prior 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.

Music Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Related Publications (9)

• Tabarro CS, de Campos LB, Galli NO, Novo NF, Pereira VM. [Effect of the music in labor and newborn]. Rev Esc Enferm USP. 2010 Jun;44(2):445-52. doi: 10.1590/s0080-62342010000200029. Portuguese.

  PMID: 20642059 BACKGROUND

• Phumdoung S, Good M. Music reduces sensation and distress of labor pain. Pain Manag Nurs. 2003 Jun;4(2):54-61. doi: 10.1016/s1524-9042(02)54202-8.

  PMID: 12836149 BACKGROUND

• Simavli S, Gumus I, Kaygusuz I, Yildirim M, Usluogullari B, Kafali H. Effect of music on labor pain relief, anxiety level and postpartum analgesic requirement: a randomized controlled clinical trial. Gynecol Obstet Invest. 2014;78(4):244-50. doi: 10.1159/000365085. Epub 2014 Sep 16.

  PMID: 25227477 BACKGROUND

• Santivanez-Acosta R, Tapia-Lopez ELN, Santero M. Music Therapy in Pain and Anxiety Management during Labor: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Oct 10;56(10):526. doi: 10.3390/medicina56100526.

  PMID: 33050409 BACKGROUND

• Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x.

  PMID: 20492051 BACKGROUND

• Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. doi: 10.1097/00000542-199808000-00005.

  PMID: 9710387 BACKGROUND

• Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.

  PMID: 23894767 BACKGROUND

• 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.

  PMID: 40019185 BACKGROUND

• 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.

  PMID: 27984250 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction; Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sophia Struzziero, Medical Student

CONTACT

6178331209; sophia.struzziero@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will listen to music (intervention) and the other group will not listen to music (control).

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 13, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)