Patient Education on Labor Analgesia Options

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT02557555
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

The purpose of this study is to learn how the investigators can better educate pregnant patients about the options open to them for pain relief during labor. Patients will receive educational pamphlet during prenatal clinic visit and again on admission to labor and delivery. The options for analgesia will be discussed by anesthesia care provider. Patient will be asked to complete a survey on the post partum unit.

Condition or Disease	Intervention/Treatment	Phase
Labor Analgesia	Other: educational information

Detailed Description

Many analgesic options exist for laboring parturients, but labor may not be the best time to start informing patients of their options. Many patients begin the labor process with a plan in place for their analgesia. Unfortunately, internet resources regarding labor analgesia that are available to the lay parturient are poor and often lead to misconceptions about the options and their risks. A significant number of patients refuse neuraxial analgesia based on misunderstandings, concerns about the procedure, or a lack of faith in the provider. Some women want a "natural childbirth" and/or control over their labor experience. Our study aimed at providing information and alternatives for labor analgesia in a simple written format.

The investigators will provide information of available labor analgesia options (epidural, combined spinal/epidural, spinal, remifentanil patient-controlled analgesia, and intravenous opioids) to expecting mothers. Using a pamphlet written in English or Spanish disseminated to pregnant women in clinic and upon arrival in the labor and delivery unit, the procedures and their risks and benefits will be explained in simple terms. In the Labor and Delivery Unit the patients will have an opportunity to ask questions of the anesthesia care giver regarding the options for analgesia. After delivery while on F Green, patients will be asked to complete a questionnaire addressing their thoughts about the pamphlets and their overall satisfaction with their labor analgesia. The analysis will focus on the utility and effect of education materials on maternal informed consent for labor analgesia, on maternal choice of analgesia modality, and on maternal anxiety regarding their labor analgesia plan.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Outcome Measures

Primary Outcome Measures

1. Survey to Determine Utility and Effect of Educational Materials [expected average of no later than 48 hours following delivery]

   In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Postpartum women ages 18 and older

• Patients who speak and read English or Spanish

• Patients who received our informational pamphlet while pregnant or in labor

• Patients who are able to consent and make medical decisions

• Patients undergoing labor or trial of labor after cesarean delivery

• Patients who undergo cesarean delivery after trial of labor

Exclusion Criteria:

• Patients unable or unwilling to complete questionnaire

• Patients unable to consent or make medical decisions

• Patients less than 18 years of age

• Patients unable to read and speak English or Spanish

• Patients in whom any of the analgesic options were contraindicated

• Patients with a history of an anxiety disorder

• Patients with precipitous labor or late presentation that precluded an analgesic intervention

• Patients with fetal distress that precluded an analgesic intervention

• Patients planned for elective cesarean section.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Newark	New Jersey	United States	07103

Sponsors and Collaborators

• Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: Antonio Gonzalez-Fiol, MD, Rutgers, NJMS

Study Documents (Full-Text)

• Study Protocol - Apr 30, 2015
• Informed Consent Form - Apr 30, 2015
• Statistical Analysis Plan - Oct 31, 2018

More Information

Publications

None provided.

• Responsible Party: Antonio Gonzalez Fiol, Anesthesiology Department, Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT02557555
• Other Study ID Numbers: 20150001531
• First Posted: Sep 23, 2015
• Last Update Posted: Oct 7, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Agnosia

Study Results

Participant Flow

Arm/Group Title	Labor Pain Control Pamphlet
Arm/Group Description	All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil patient controlled analgesia, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
Period Title: Overall Study
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Labor Pain Control Pamphlet
Arm/Group Description	All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
Overall Participants	100
Age, Customized (Count of Participants)
18-45 years	100 100%
Sex: Female, Male (Count of Participants)
Female	100 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	100 100%
Patients completing survey (Count of Participants)
Count of Participants [Participants]	100 100%

Outcome Measures

1. Primary Outcome

Title	Survey to Determine Utility and Effect of Educational Materials
Description	In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?
Time Frame	expected average of no later than 48 hours following delivery

Outcome Measure Data

Analysis Population Description

The answers from 100 female patients, ages 18-45 admitted to the L&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet.

Arm/Group Title	Yes %	No %
Arm/Group Description	Percentage of patients responding Yes to one of the key questions of the study regarding education value of the pamphlet and anxiety level.	Percentage of patients responding no to the key questions regarding the provided pamphlet educational value or anxiety
Measure Participants	100	100
Researched options for labor pain	79	21
Pamphlet better explained options for pain	93	7
Pamphlet should be given before onset labor pain	97	3
Pamphlet information helped to reduce anxiety	90	10
Information corrected any misconception	71	29
Written information should always be available	100	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments	P-values corresponding to a test of equal proportions (yes/no- 50%/50%)
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Researched options for labor pain
	Method	Test of equal proportion (50/50)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments	P-values corresponding to a test of equal proportions (yes/no- 50%/50%)
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Pamphlet better explained options for pain
	Method	Test of equal proportion (50/50)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Pamphlet should be given before onset labor pain
	Method	Test of equal proportion (50/50)
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Pamphlet information helped to reduce anxiety
	Method	Test of equal proportion (50/50)
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments	Information corrected any misconception
	Method	Test of equal proportion (50/50)
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Yes %, No %
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Written information should always be available
	Method	Test of equal proportion (50/50)
	Comments

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Given that the patients were asked to fill up a 24 question survey, no patient was exposed to any risk. That is, there was no interventional or placebo/drug arm in this study.
Arm/Group Title	Labor Pain Control Pamphlet
Arm/Group Description	All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
All Cause Mortality
	Labor Pain Control Pamphlet
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Labor Pain Control Pamphlet
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Labor Pain Control Pamphlet
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.