Sequential Allocation Study of Music Duration

NCT04909736 | Completed

• 1 other identifier: 00001496
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are interested in studying the effects of varying lengths of musical exposure on patient anxiety and stress levels.

Conditions

Anxiety; Patient Satisfaction; Music Exposure

Keywords

Music, Anxiety,

Outcome Measures

Primary Outcomes (1)

• Change in anxiety through a questionnaire rating anxiety levels on a scale of 0-10

  Investigators will measure the patient's anxiety pre exposure on a scale of 0-10, with 0 being no anxiety and 10 being extreme anxiety. Anxiety will be assessed again on the same scale post musical exposure.

  baseline and up to 60 minutes after exposure.

Secondary Outcomes (3)

• General Musical Experience

  Up to 60 minutes after musical exposure

• Change in Heart Rate between baseline and at end of exposure

  baseline and up to 60 minutes after exposure.

• Change in Blood Pressure between baseline and at the end of exposure

  baseline and up to 60 minutes after exposure.

Study Arms (2)

Music Exposure

EXPERIMENTAL

Patient will listen to a specified duration of music.

Other: Music Exposure

No-Music Exposure

NO INTERVENTION

Patient will not listen to music to for specified duration of time.

Interventions

Music Exposure OTHER

Music will be played for participants.

Music Exposure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50
• Elective scheduled cesarean delivery
• Able to provide informed consent

You may not qualify if:

• Patient refusal
• Impaired hearing
• Patient taking at least one anti-anxiolytic medication on a daily basis at baseline
• No anxiety (a score of 0, on a scale of 0-10 of pre-music exposure anxiety) after consent is given.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (4)

• Conrad C. Music for healing: from magic to medicine. Lancet. 2010 Dec 11;376(9757):1980-1. doi: 10.1016/s0140-6736(10)62251-9. No abstract available.

  PMID: 21171230 BACKGROUND

• Huang ST, Good M, Zauszniewski JA. The effectiveness of music in relieving pain in cancer patients: a randomized controlled trial. Int J Nurs Stud. 2010 Nov;47(11):1354-62. doi: 10.1016/j.ijnurstu.2010.03.008. Epub 2010 Apr 18.

  PMID: 20403600 BACKGROUND

• Drzymalski DM, Lumbreras-Marquez MI, Tsen LC, Camann WR, Farber MK. The effect of patient-selected or preselected music on anxiety during cesarean delivery: a randomized controlled trial. J Matern Fetal Neonatal Med. 2020 Dec;33(24):4062-4068. doi: 10.1080/14767058.2019.1594766. Epub 2019 Mar 27.

  PMID: 30880522 BACKGROUND

• Gorges M, Zhou G, Brant R, Ansermino JM. Sequential allocation trial design in anesthesia: an introduction to methods, modeling, and clinical applications. Paediatr Anaesth. 2017 Mar;27(3):240-247. doi: 10.1111/pan.13088. Epub 2017 Feb 17.

  PMID: 28211193 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Model Details: The investigators will use a sequential allocation approach where subsequent parameters of the study are adjusted based on the accrued data. Allocation methods will follow an up and down model, where patients musical exposure time will be determined based on the success or failure of the patient immediately preceding them.

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 2, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)