Women Empowered Through Education to Breastfeed

Pain Clinical Trial

Official title:

Empowering Women to Cope With Breastfeeding Pain: A Feasibility Randomized Controlled Trial of an Educational Anticipatory Guidance Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481166
• Other study ID #: 111412
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: October 2019

Study information

• Verified date: May 2019
• Source: Western University, Canada
• Contact: Kimberley T Jackson, PhD
• Phone: 519-661-2111
• Email: kim.jackson[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 [1,3]. 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 (e.g., 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 in/awaiting 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 (n=20) or control group (n=20). 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 peers/family 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

Women who self-enrolled in prenatal education classes at public health unit who:

• Can read and write in English

• Less than or equal to 32 weeks gestation (in pregnancy)

• Planning to breastfeed their infant

• 19 years of age or older

• Internet accessible

Exclusion Criteria:

• Greater than 32 weeks gestation

• have been identified as having a high-risk pregnancy

• have self-identified barriers to breastfeeding

• have peers or family already enrolled in the study

Related Conditions & MeSH terms

• Breastfeeding
• Pain

Intervention

Other:
• Education on breastfeeding pain
A Registered Nurse with specialization in antenatal and postpartum care will deliver a one-hour, group-based educational session specifically on breastfeeding-related pain, including: common causes of nipple pain, prevalence of nipple pain, impact of pain on milk ejection reflex, and common approaches to prevention and management of nipple pain.

Locations

Country	Name	City	State
Canada	Middlesex London Health Unit	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maternal satisfaction	Women's self-report of satisfaction with the education they received will be measured by asking women: "were you satisfied receiving additional breastfeeding education", "how effective was the breastfeeding education session in helping you to breastfeed your baby", "how effective was the additional breastfeeding education session in helping you to anticipate the possibility of breastfeeding pain". Responses will include descriptions on a 5 point Likert scale. For example, "1" for "very satisfied", and "5 for "very dissatisfied". There are no reliable, validated measurement tools measuring maternal satisfaction in this context.	2 and 4 weeks postpartum
Other	breastfeeding self-efficacy	Self reported maternal breastfeeding self-efficacy will be measured using the Breastfeeding self-efficacy scale short form (Dennis, 2003. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs, 32(6), 734-44)	2 and 4 weeks postpartum
Other	women's attitude toward breastfeeding	Self reported maternal attitude toward breastfeeding will be measured using the Iowa Infant Feeding Attitude Scale (De la Mora et al., 1999. The Iowa Infant Feeding Attitude Scale: Analysis of reliability and validity. Journal of Applied Social Psychology, 29(11), 2362-2380)	2 and 4 weeks postpartum
Primary	Breastfeeding duration	Breastfeeding duration will be measured by asking women if they have breastfed in the past 24 hours or not. If a participant has stopped breastfeeding, they will be asked for the last date they breastfed their infant to determine the number of days (duration) of breastfeeding.	4 weeks postpartum
Secondary	Breastfeeding exclusivity	Breastfeeding exclusivity is defined as the receipt of breast milk only with no additional food or liquid, including water. Breastfeeding exclusivity will be categorized according to the World Health Organization Infant and Young Child Feeding guidelines (2009) with the following categories: exclusive breastfeeding, predominant, complimentary feeding, breastfeeding or bottle-feeding. Among the extant breastfeeding literature, this is the most commonly utilized means to measure breastfeeding exclusivity.	2 and 4 weeks postpartum
Secondary	Pain severity	Pain severity will be measured using an 11-point numeric rating scale, where zero represents no pain, and 10 represents the worst pain imaginable.	4 weeks postpartum