Anxiety
Conditions
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.
Interventions
OTHERMozart selections
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.
OTHERPatient-preferred music selections
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.
Sponsors
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Planning on scheduled cesarean section or non-emergent unscheduled 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Score | 4-8 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STAI | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mozart 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. | 20 |
| Patient Preference Subjects in this arm listened to music from a list of pre-selected pieces of their own choosing. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Mozart | Patient Preference | Total |
|---|---|---|---|
| Age, Continuous | 32.7 Years STANDARD_DEVIATION 5.4 | 33.5 Years STANDARD_DEVIATION 4.9 | 33.0 Years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 16 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age | 38.6 Weeks STANDARD_DEVIATION 0.8 | 38.6 Weeks STANDARD_DEVIATION 0.9 | 38.6 Weeks STANDARD_DEVIATION 0.9 |
| Gravidity | 2.4 Pregnancies STANDARD_DEVIATION 1 | 3.6 Pregnancies STANDARD_DEVIATION 1.3 | 3 Pregnancies STANDARD_DEVIATION 2.2 |
| Parity | 1.1 Births STANDARD_DEVIATION 0.8 | 1.3 Births STANDARD_DEVIATION 1.4 | 1.2 Births STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Anxiety Score
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.
Time frame: 4-8 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mozart | Anxiety Score | After | 3.6 score on a scale | Standard Deviation 2.3 |
| Mozart | Anxiety Score | Before | 5.9 score on a scale | Standard Deviation 2.6 |
| Patient Preference | Anxiety Score | Before | 6.1 score on a scale | Standard Deviation 2.3 |
| Patient Preference | Anxiety Score | After | 3.1 score on a scale | Standard Deviation 2.4 |
Secondary
STAI
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.
Time frame: 4-8 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mozart | STAI | Before | 12.7 score on a scale | Standard Deviation 4.3 |
| Mozart | STAI | After | 10.3 score on a scale | Standard Deviation 3.2 |
| Patient Preference | STAI | Before | 14.4 score on a scale | Standard Deviation 4.1 |
| Patient Preference | STAI | After | 10.8 score on a scale | Standard Deviation 3.2 |