Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03481166
Status:
COMPLETED
Last Update Posted:
2019-05-24
First Post:
2018-02-14
Brief Title:
Women Empowered Through Education to Breastfeed
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Empowering Women to Cope with Breastfeeding Pain a Feasibility Randomized Controlled Trial of an Educational Anticipatory Guidance Intervention
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The experience of breastfeeding-related pain is common for postpartum women but is not often anticipated as part of the postpartum experience This feasibility randomized controlled trial aims to examine the effectiveness of a nurse-led educational intervention using anticipatory guidance among pregnant women wishing to breastfeed on breastfeeding outcomes breastfeeding-related pain and maternal satisfaction
Detailed Description:
Despite the relative ubiquity of breastfeeding-related pain exploratory studies suggest women are largely unprepared for breastfeeding-related pain in the early postpartum period 1-3 In turn postpartum women often experience an incongruence between how breastfeeding is idealized by Western society and the reality of their early breastfeeding experiences Furthermore painful breastfeeding experiences serve to intensify this incongruity and may lead to disillusionment feelings of negative self-worth and premature breastfeeding cessation 13 As such the overarching goals of this one-year project are to compare usual prenatal education to anticipatory guidance to 1 examine the effectiveness of a breastfeeding education session using anticipatory guidance on breastfeeding outcomes and satisfaction during the postpartum period and 2 test the feasibility of the methods and procedures needed for the successful implementation and validity of a full-scale randomized controlled trial RCT This one-year project has 5 objectives
To fill a knowledge gap in nursing and allied health-related literature by examining the effect of a one-hour nurse-led breastfeeding education session using anticipatory guidance during pregnancy on Objective 1 breastfeeding duration and exclusivity versus those receiving usual prenatal education Objective 2 overall satisfaction with the educational experience versus those receiving usual prenatal education Objective 3 breastfeeding self-efficacy and infant feeding attitudes Objective 4 postpartum breastfeeding-related pain and Objective 5 To determine if this intervention study protocol is practical eg accrual rates satisfaction compliance sample size and to test the process resources management and scientific basis 4 for a future full-scale RCT
Forty pregnant women enrolled in prenatal classes provided by the Middlesex London Health Unit MLHU and who are intending to breastfeed will be enrolled in this feasibility randomized controlled trial
Following ethics approval interested pregnant women who have enrolled inawaiting antenatal classes at the MLHU will contact the RA to discuss the study Interested women will be screened for eligibility and if eligible and consenting baseline data will be collected Participants will then be randomized to either intervention n20 or control group n20 Randomization will be achieved by using sealed opaque sequentially numbered envelopes containing randomly generated numbers prepared by an RA external to the study An RA will open the next sequentially numbered envelope and reveal the group allocation to the participant The control group will receive usual antenatal education provided to all women who enroll in MLHU prenatal classes The intervention group will receive an additional one-hour booster session by a perinatal RN of antenatal education specifically focused on the postpartum experience of breastfeeding including anticipatory guidance around breastfeeding-related pain and management strategies To control for contamination women who have peersfamily already in the study will be excluded An emailed link to a follow-up questionnaire will be sent at 2 and 4 weeks postpartum to determine if they are breastfeeding or not breastfeeding exclusivity level of breastfeeding-related pain breastfeeding self-efficacy maternal attitudes toward infant feeding and maternal satisfaction with antenatal education
To fill a knowledge gap in nursing and allied health-related literature by examining the effect of a one-hour nurse-led breastfeeding education session using anticipatory guidance during pregnancy on Objective 1 breastfeeding duration and exclusivity versus those receiving usual prenatal education Objective 2 overall satisfaction with the educational experience versus those receiving usual prenatal education Objective 3 breastfeeding self-efficacy and infant feeding attitudes Objective 4 postpartum breastfeeding-related pain and Objective 5 To determine if this intervention study protocol is practical eg accrual rates satisfaction compliance sample size and to test the process resources management and scientific basis 4 for a future full-scale RCT
Forty pregnant women enrolled in prenatal classes provided by the Middlesex London Health Unit MLHU and who are intending to breastfeed will be enrolled in this feasibility randomized controlled trial
Following ethics approval interested pregnant women who have enrolled inawaiting antenatal classes at the MLHU will contact the RA to discuss the study Interested women will be screened for eligibility and if eligible and consenting baseline data will be collected Participants will then be randomized to either intervention n20 or control group n20 Randomization will be achieved by using sealed opaque sequentially numbered envelopes containing randomly generated numbers prepared by an RA external to the study An RA will open the next sequentially numbered envelope and reveal the group allocation to the participant The control group will receive usual antenatal education provided to all women who enroll in MLHU prenatal classes The intervention group will receive an additional one-hour booster session by a perinatal RN of antenatal education specifically focused on the postpartum experience of breastfeeding including anticipatory guidance around breastfeeding-related pain and management strategies To control for contamination women who have peersfamily already in the study will be excluded An emailed link to a follow-up questionnaire will be sent at 2 and 4 weeks postpartum to determine if they are breastfeeding or not breastfeeding exclusivity level of breastfeeding-related pain breastfeeding self-efficacy maternal attitudes toward infant feeding and maternal satisfaction with antenatal education
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None