Trial Outcomes & Findings for The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy (NCT NCT01834027)
NCT ID: NCT01834027
Last Updated: 2016-04-15
Results Overview
Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU
Results posted on
2016-04-15
Participant Flow
Participant milestones
| Measure |
Jazz Music
Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
|
No Music
The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Jazz on Postoperative Pain and Stress in Patients Undergoing Elective Hysterectomy
Baseline characteristics by cohort
| Measure |
Jazz Music
n=28 Participants
Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
|
No Music
n=28 Participants
The patients in this group will have noise-cancelling headphones but no music will be played.
No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years of age
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Age, Customized
>=18 and <=75 years
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
56 participants
n=206 Participants
|
|
Age, Customized
> 75 years of age
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
56 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACUMean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry
Outcome measures
| Measure |
Jazz Music
n=28 Participants
Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
|
No Music
n=28 Participants
The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU
|
|---|---|---|
|
Change in Heart Rate From Baseline on Arrival in PACU
5 minutes after baseline measurement
|
-3.39 beats per minute
Interval -7.03 to -0.25
|
-5.11 beats per minute
Interval -8.75 to -1.47
|
|
Change in Heart Rate From Baseline on Arrival in PACU
10 minutes after baseline measurement
|
-4.18 beats per minute
Interval -8.37 to 0.02
|
-4.71 beats per minute
Interval -8.91 to -0.52
|
|
Change in Heart Rate From Baseline on Arrival in PACU
15 minutes after baseline measurement
|
-5.21 beats per minute
Interval -9.67 to -0.75
|
-6.46 beats per minute
Interval -10.93 to -1.98
|
|
Change in Heart Rate From Baseline on Arrival in PACU
2- minutes after baseline measurement
|
-6.29 beats per minute
Interval -11.23 to -1.34
|
-6.61 beats per minute
Interval -11.57 to -1.66
|
|
Change in Heart Rate From Baseline on Arrival in PACU
25 minutes aqfter baseline measurement
|
-6.68 beats per minute
Interval -11.57 to -1.79
|
-8.58 beats per minute
Interval -13.49 to -3.67
|
|
Change in Heart Rate From Baseline on Arrival in PACU
30 minutes after baseline measurement
|
-5.71 beats per minute
Interval -10.74 to -0.96
|
-5.36 beats per minute
Interval -10.11 to -0.6
|
SECONDARY outcome
Timeframe: Once, at 30 minutes after the patient entered the PACUPopulation: 2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.
Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.
Outcome measures
| Measure |
Jazz Music
n=26 Participants
Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
|
No Music
n=27 Participants
The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU
|
|---|---|---|
|
Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU
|
0.1 units on a scale
Standard Deviation 0.92
|
0 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 10, 20 , and 30 minutes after baseline measurementThe patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.
Outcome measures
| Measure |
Jazz Music
n=28 Participants
Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.
Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
|
No Music
n=28 Participants
The patients in this group with have headphones but no music will be played.
No music: In this group nu music will be played in PACU
|
|---|---|---|
|
Mean Difference in Patient's Perception of Pain From Baseline
30 minutes after baseline measurement
|
0.77 units on a scale
Interval -0.83 to 2.36
|
-.03 units on a scale
Interval -1.92 to 1.33
|
|
Mean Difference in Patient's Perception of Pain From Baseline
10 minutes after baseline measurement
|
1.04 units on a scale
Interval -0.28 to 2.35
|
-0.95 units on a scale
Interval -2.31 to 0.4
|
|
Mean Difference in Patient's Perception of Pain From Baseline
20 minutes after baseline measurement
|
0.61 units on a scale
Interval -0.8 to 2.02
|
-0.16 units on a scale
Interval -1.61 to 1.28
|
SECONDARY outcome
Timeframe: 60 minutesnon-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes
Outcome measures
Outcome data not reported
Adverse Events
Jazz Music
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Music
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place