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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Group | Active Comparator | 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. |
|
| Website Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Access to routine information | Other | Access to routine pain-control information |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Following delivery and prior to discharge, up to two days |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Analgesia Utilization Rate | Number of patients receiving epidural analgesia | On day of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Reyes, MD | University of New Mexico Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Hospital | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Website Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Following delivery and prior to discharge, up to two days |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Officer | University of New Mexico Anesthesiology Department | 505-272-2610 | hsc-anesthesiology@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2020 | Jan 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Access to website |
| Other |
Access to informational website: thepainlesspush.com |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Language preference | Count of Participants | Participants |
|
| Had chosen preferred labor analgesia type before hospital arrival | Count of participants who had chosen a preferred type of labor analgesia during pregnancy, before arriving at the hospital for labor | Count of Participants | Participants |
|
| Arrived at hospital desiring labor epidural | Count of participants who had chosen labor epidural as the preferred type of analgesia during pregnancy, before arriving at the hospital for labor | Count of Participants | Participants |
|
| OG001 | 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 |
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| Secondary | Epidural Analgesia Utilization Rate | Number of patients receiving epidural analgesia | Posted | Count of Participants | Participants | On day of delivery |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | 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 | 0 | 43 | 0 | 43 | 0 | 43 |
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