Trial Outcomes & Findings for Pain Relief Satisfaction With New Educational Materials (NCT NCT03698773)
NCT ID: NCT03698773
Last Updated: 2024-08-27
Results Overview
Satisfaction as measured by agreement with Likert scale questionnaire item "I was satisfied with my choice for pain control in labor" where 1 = strongly disagree, 3 = neither agree nor disagree, and 5 = strongly agree. High scores indicate high satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Following delivery and prior to discharge, up to two days
Results posted on
2024-08-27
Participant Flow
Participant milestones
| Measure |
Baseline Group
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine information: Access to routine pain-control information
|
Website Group
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to website: Access to informational website: thepainlesspush.com
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
56
|
|
Overall Study
COMPLETED
|
48
|
55
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Baseline Group
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine information: Access to routine pain-control information
|
Website Group
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to website: Access to informational website: thepainlesspush.com
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Group
n=50 Participants
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine information: Access to routine pain-control information
|
Website Group
n=56 Participants
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to website: Access to informational website: thepainlesspush.com
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=50 Participants
|
29 years
n=56 Participants
|
29 years
n=106 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
56 Participants
n=56 Participants
|
106 Participants
n=106 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=106 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
56 participants
n=56 Participants
|
106 participants
n=106 Participants
|
|
Language preference
English
|
39 Participants
n=50 Participants
|
43 Participants
n=56 Participants
|
82 Participants
n=106 Participants
|
|
Language preference
Spanish
|
9 Participants
n=50 Participants
|
12 Participants
n=56 Participants
|
21 Participants
n=106 Participants
|
|
Language preference
Unknown
|
2 Participants
n=50 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=106 Participants
|
|
Had chosen preferred labor analgesia type before hospital arrival
|
40 Participants
n=50 Participants
|
42 Participants
n=56 Participants
|
82 Participants
n=106 Participants
|
|
Arrived at hospital desiring labor epidural
|
27 Participants
n=50 Participants
|
29 Participants
n=56 Participants
|
56 Participants
n=106 Participants
|
PRIMARY outcome
Timeframe: Following delivery and prior to discharge, up to two daysPopulation: Data on this outcome are available for n=97 participants total. A total of 9 participants (4 in the Baseline group and 5 in the Website group) did not provide data on the primary outcome.
Satisfaction as measured by agreement with Likert scale questionnaire item "I was satisfied with my choice for pain control in labor" where 1 = strongly disagree, 3 = neither agree nor disagree, and 5 = strongly agree. High scores indicate high satisfaction.
Outcome measures
| Measure |
Baseline Group
n=46 Participants
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine information: Access to routine pain-control information
|
Website Group
n=51 Participants
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to website: Access to informational website: thepainlesspush.com
|
|---|---|---|
|
Patient Satisfaction With Pain Control in Labor
|
5 score on a scale
Interval 3.0 to 5.0
|
5 score on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: On day of deliveryNumber of patients receiving epidural analgesia
Outcome measures
| Measure |
Baseline Group
n=48 Participants
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine information: Access to routine pain-control information
|
Website Group
n=55 Participants
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to website: Access to informational website: thepainlesspush.com
|
|---|---|---|
|
Epidural Analgesia Utilization Rate
|
41 Participants
|
46 Participants
|
Adverse Events
Baseline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Website Group
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
Research Officer
University of New Mexico Anesthesiology Department
Phone: 505-272-2610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place