Back to resultsDosing Music for Anxiety Reduction in Parturients
Primary Purpose
Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mozart selections
Patient-preferred music selections
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Planning on scheduled cesarean section Able to provide informed consent American Society of Anaesthesiologists (ASA) physical status score of II-III Exclusion Criteria: Patient refusal Impaired hearing Patient is taking at least one anxiolytic medication daily at baseline No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given ASA IV or higher
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mozart
Patient preference
Arm Description
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.
Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
Outcomes
Primary Outcome Measures
Anxiety Score
STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05966766
Brief Title
Dosing Music for Anxiety Reduction in Parturients
Official Title
Estimating the Effective Dose of Music Duration for Anxiety Reduction Prior to Scheduled Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical study that aims to determine the effective dose of music listening duration that is required to reduce anxiety in patients awaiting scheduled cesarean section. It will also compare types of music to accomplish this goal, both of which have been shown effective in prior studies. Methods will involve enrolling and playing music for patients awaiting scheduled C-section, and scoring their anxiety with pre- and post-music questionnaires. Music duration for each subject will be predetermined, and analysis of response will be performed to determine the effective dose 95%, or dose at which 95% of subjects should have a positive response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mozart
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient preference
Arm Type
Active Comparator
Arm Description
Subjects in this arm will listen to music from a list of pre-selected pieces of their own choosing.
Intervention Type
Other
Intervention Name(s)
Mozart selections
Intervention Description
Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections by Mozart of previously studied and shown to reduce anxiety.
Intervention Type
Other
Intervention Name(s)
Patient-preferred music selections
Intervention Description
Music will be played from a speaker connected to a media-playing device for participants to listen to for set durations of time. Music will be selections of patient choice.
Primary Outcome Measure Information:
Title
Anxiety Score
Description
STAI questionnaire consisting of rating pain and anxiety on scale of 0-10 followed by 6 questions to further qualitatively assess anxiety levels.
Time Frame
1-8 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 years or older
Planning on scheduled cesarean section
Able to provide informed consent
American Society of Anaesthesiologists (ASA) physical status score of II-III
Exclusion Criteria:
Patient refusal
Impaired hearing
Patient is taking at least one anxiolytic medication daily at baseline
No anxiety (a score of 0, on a scale of 0-10, of pre-music exposure anxiety) after consent is given
ASA IV or higher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Drzymalski, MD
Phone
617-913-8168
Email
ddrzymalski@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tristan Fong, BS
Email
tristan.fong@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
Phone
617-913-8168
Email
ddrzymalski@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Dan Drzymalski, MD
First Name & Middle Initial & Last Name & Degree
Tristan Fong, BS
12. IPD Sharing Statement
Learn more about this trial
Dosing Music for Anxiety Reduction in Parturients
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