Trial Outcomes & Findings for Dosing Music for Anxiety Reduction in Parturients (NCT NCT05966766)

Last Updated: 2025-05-30

Results Overview

Verbally rated anxiety on numeric rating scale (NRS) of 0-10, before and after intervention. A rating of 0 meant the patient had no anxiety, while a rating of 10 meant the patient had the worst anxiety possible. Must have been at least a 1-point decrease between pre- and post-intervention scores to be considered a positive response, larger decrease meant a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

4-8 minutes

Results posted on

2025-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Mozart Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.	Patient Preference Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dosing Music for Anxiety Reduction in Parturients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mozart n=20 Participants Subjects in this arm listened to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.	Patient Preference n=20 Participants Subjects in this arm listened to music from a list of pre-selected pieces of their own choosing.	Total n=40 Participants Total of all reporting groups
Age, Continuous	32.7 Years STANDARD_DEVIATION 5.4 • n=5 Participants	33.5 Years STANDARD_DEVIATION 4.9 • n=7 Participants	33.0 Years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gestational age	38.6 Weeks STANDARD_DEVIATION 0.8 • n=5 Participants	38.6 Weeks STANDARD_DEVIATION 0.9 • n=7 Participants	38.6 Weeks STANDARD_DEVIATION 0.9 • n=5 Participants
Gravidity	2.4 Pregnancies STANDARD_DEVIATION 1 • n=5 Participants	3.6 Pregnancies STANDARD_DEVIATION 1.3 • n=7 Participants	3 Pregnancies STANDARD_DEVIATION 2.2 • n=5 Participants
Parity	1.1 Births STANDARD_DEVIATION 0.8 • n=5 Participants	1.3 Births STANDARD_DEVIATION 1.4 • n=7 Participants	1.2 Births STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 4-8 minutes

Outcome measures

Outcome measures
Measure	Mozart n=20 Participants Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.	Patient Preference n=20 Participants Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
Anxiety Score Before	5.9 score on a scale Standard Deviation 2.6	6.1 score on a scale Standard Deviation 2.3
Anxiety Score After	3.6 score on a scale Standard Deviation 2.3	3.1 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 4-8 minutes

6-question abbreviated state-trait anxiety inventory (STAI) questions asked and scored on a 6-24 point scale (higher is more anxiety) for before and after intervention. Decrease in score after intervention was considered a positive response, with larger decreases indicating better responses.

Outcome measures

Outcome measures
Measure	Mozart n=20 Participants Subjects in this arm will listen to music from a list of pre-selected pieces by Mozart that have been previously shown to have beneficial effects on anxiety.	Patient Preference n=20 Participants Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
STAI Before	12.7 score on a scale Standard Deviation 4.3	14.4 score on a scale Standard Deviation 4.1
STAI After	10.3 score on a scale Standard Deviation 3.2	10.8 score on a scale Standard Deviation 3.2

Adverse Events

Mozart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Preference

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dan Drzymalski, MD

Tufts Medical Center

Phone: 617-913-8168‬‬‬‬‬‬‬‬‬‬‬‬‬‬

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place