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Pain Relief Satisfaction With New Educational Materials

Satisfaction of Pain Relief During Labor and Delivery Following Access to New Educational Materials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03698773
Enrollment
106
Registered
2018-10-09
Start date
2018-10-01
Completion date
2020-04-09
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction

Brief summary

This study compares patient satisfaction after labor and delivery with access to either the default educational materials available, or to a table computer set to display an educational website, thepainlesspush.com.

Detailed description

This is a prospective randomized controlled study. The investigators hypothesize that parturients with access to the website will exhibit greater satisfaction with labor and delivery pain control. Potential participants will be recruited from the University of New Mexico Hospital (UNMH) Labor & Delivery floor. Patients will be enrolled following an oral consent process. They will be randomized into either control group or intervention group. Control group participants will have their standard of care visit with an anesthesiologist and routine hospital pain-relief information. Intervention group participants will have their standard of care visit with an anesthesiologist, plus one hour in which to view the patient education website thepainlesspush.com, on an iPad provided by the Anesthesiology department for this purpose. After their delivery and transfer to the mother/baby unit, participants will complete a satisfaction survey brought to them by a study team member. Participants will complete the survey following their delivery and prior to discharge. The primary team will notify us with expected discharge in which we will retrieve the survey from them in their room and answer any last questions. Their active participation in the study will be complete at this time. After a participant completes the satisfaction survey, research team members will collect demographic information and relevant obstetric/medical history information from the electronic medical record.

Interventions

OTHERAccess to routine information

Access to routine pain-control information

OTHERAccess to website

Access to informational website: thepainlesspush.com

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All English- or Spanish-speaking patients who are admitted to UNMH Labor and Delivery for planned progression to active labor.

Exclusion criteria

* Age under 18 years * Patients unable to provide consent for medical procedures * Patients who do not speak either English or Spanish

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction With Pain Control in LaborFollowing delivery and prior to discharge, up to two daysSatisfaction 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.

Secondary

MeasureTime frameDescription
Epidural Analgesia Utilization RateOn day of deliveryNumber of patients receiving epidural analgesia

Countries

United States

Participant flow

Participants by arm

ArmCount
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
50
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
56
Total106

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21

Baseline characteristics

CharacteristicBaseline GroupWebsite GroupTotal
Age, Continuous28 years29 years29 years
Arrived at hospital desiring labor epidural27 Participants29 Participants56 Participants
Had chosen preferred labor analgesia type before hospital arrival40 Participants42 Participants82 Participants
Language preference
English
39 Participants43 Participants82 Participants
Language preference
Spanish
9 Participants12 Participants21 Participants
Language preference
Unknown
2 Participants1 Participants3 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
50 participants56 participants106 participants
Sex: Female, Male
Female
50 Participants56 Participants106 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 43
other
Total, other adverse events
0 / 370 / 43
serious
Total, serious adverse events
0 / 370 / 43

Outcome results

Primary

Patient Satisfaction With Pain Control in Labor

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.

Time frame: Following delivery and prior to discharge, up to two days

Population: 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.

ArmMeasureValue (MEDIAN)
Baseline GroupPatient Satisfaction With Pain Control in Labor5 score on a scale
Website GroupPatient Satisfaction With Pain Control in Labor5 score on a scale
p-value: 0.16Wilcoxon (Mann-Whitney)
Secondary

Epidural Analgesia Utilization Rate

Number of patients receiving epidural analgesia

Time frame: On day of delivery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline GroupEpidural Analgesia Utilization Rate41 Participants
Website GroupEpidural Analgesia Utilization Rate46 Participants
p-value: >0.99Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026