The BSM Intervention for Acute Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Pain+4 MoreThe BSM Intervention - Behavioral
Eligibility
18 - 45
Female
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Study Summary

This trial is testing a self-management intervention for breastfeeding and breast and nipple pain to see if it decreases pain intensity and interference and increases breastfeeding exclusivity.

Eligible Conditions
  • Acute Pain
  • Parent-Child Relationship
  • Exclusive Breastfeeding
  • Maternal Distress
  • Self-Efficacy

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: Baseline to 24 weeks

Baseline to 24 weeks
Breast and nipple pain severity measured by Brief Pain Inventory pain intensity summary score from baseline to 24 weeks.
Breast and nipple pain severity measured by a self-report visual analogue scale from baseline to 24 weeks.
Percentage of participants who continue to breastfeeding from baseline to 24 weeks via self-report
Baseline to 24 weeks.
Breast and nipple pain severity measured by Brief Pain Inventory pain interference summary score from baseline to 24 weeks.

Trial Safety

Trial Design

2 Treatment Groups

Attention Control
1 of 2
The BSM Intervention
1 of 2

Active Control

Experimental Treatment

222 Total Participants · 2 Treatment Groups

Primary Treatment: The BSM Intervention · No Placebo Group · N/A

The BSM Intervention
Behavioral
Experimental Group · 1 Intervention: The BSM Intervention · Intervention Types: Behavioral
Attention Control
Behavioral
ActiveComparator Group · 1 Intervention: Attention Control · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 24 weeks

Who is running the clinical trial?

UConn HealthOTHER
197 Previous Clinical Trials
58,076 Total Patients Enrolled
University of ConnecticutLead Sponsor
161 Previous Clinical Trials
156,344 Total Patients Enrolled
Hartford HealthCareOTHER
6 Previous Clinical Trials
674 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
529 Previous Clinical Trials
10,287,508 Total Patients Enrolled
2 Trials studying Acute Pain
473 Patients Enrolled for Acute Pain
Ruth F Lucas, PhDPrincipal InvestigatorUniversity of Connecticut

Eligibility Criteria

Age 18 - 45 · Female Participants · 1 Total Inclusion Criteria

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References