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Self-Management Intervention for Breastfeeding Pain (PROMPT Trial)
PROMPT Trial 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.
PROMPT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PROMPT Trial Design
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Who is running the clinical trial?
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- You are younger than 18 or older than 45 years old.Your baby was born with health problems or birth defects.You have a history of serious mental health issues, like major depression or schizophrenia, which may make it harder for you to take care of yourself.Gave birth to a baby within the last 48 hours who was full-term (at least 37 weeks gestational age)You have received basic education about breastfeeding during your prenatal care.You have skin conditions on your less-used arm that could affect the accuracy of nerve function tests.You are between 18 and 45 years old.Evaluated by a breastfeeding expert while breastfeeding.
- Group 1: The BSM Intervention
- Group 2: Attention Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are individuals aged 45+ eligible for participation in this investigation?
"As outlined in the entrance requirements, individuals with ages between 18 and 45 are eligible to participate."
Are participants being taken for this medical experiment at present?
"Affirmative. Information on clinicaltrials.gov verifies that this research project, which was first posted in March 16th 2022, is actively recruiting participants. Specifically, 222 individuals need to be recruited at 2 separate medical sites."
Could I be eligible to partake in this medical investigation?
"To qualify for entry into the trial, patients must have acute pain and be between 18 - 45 years old. Currently 222 individuals are accepted to take part in this clinical study."
What is the current enrollment numbers of this research study?
"Affirmative. Clinical trials data affirms that this study is presently searching for volunteers, having been posted on March 16th 2022 and updated most recently in June 15th 2022. Recruitment will target 222 patients split between 2 sites."
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