Breastfeeding, Nipple Pain During Lactation, Pain
Conditions
Keywords
pilot, randomized controlled trial, prenatal education, anticipatory guidance
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 \[1,3\]. 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.
Interventions
OTHEREducation 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.
Sponsors
Women's College Hospital
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding duration | 4 weeks postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding exclusivity | 2 and 4 weeks postpartum | 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. |
| Pain severity | 4 weeks postpartum | Pain severity will be measured using an 11-point numeric rating scale, where zero represents no pain, and 10 represents the worst pain imaginable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| maternal satisfaction | 2 and 4 weeks postpartum | 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. |
| breastfeeding self-efficacy | 2 and 4 weeks postpartum | 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) |
| women's attitude toward breastfeeding | 2 and 4 weeks postpartum | 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) |
Countries
Canada
Outcome results
None listed