- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05400382
Maternal Mindfulness: Depression and Postpartum Pain (MaMiDaPP)
Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Postpartum pain affects approximately 92% of women and is a risk factor for postpartum depression (PPD). Cesarean delivery is associated with elevated risk for both postpartum pain and PPD, and women who experience persistent postpartum pain are at increased risk of developing depressive symptoms. PPD may contribute to withdrawal, emotional detachment, and hostility, which can negatively affect mother-infant interactions, including breastfeeding. These risks underscore the urgent need for an effective non-pharmacologic intervention to reduce post-cesarean delivery pain and prevent PPD. The objective of this study is to optimize a mobile, self-guided 8-week Mindfulness-Based Stress Reduction (MBSR) intervention for non-depressed women at risk for PPD who have a planned cesarean delivery. The investigators will conduct a single-group open trial of women (N = 20), including Latinas (English- and Spanish-speaking), Asian, African American, and non-Hispanic White women. The study is testing two primary hypotheses: (1) the 8-week mobile MBI will demonstrate high feasibility and acceptability among a diverse sample of women, shown by meeting target recruitment, enrollment, and retention benchmarks and (2) participants will demonstrate reductions in reported pain scores and depressive symptoms from pre- to post-intervention. In addition, the study will evaluate recruitment, enrollment, dosage, safety, and retention metrics and survey participants about intervention features, facilitators, barriers, satisfaction, and recommendations.
Participants will be recruited through community partners, including the Champaign-Urbana Public Health District and the University YMCA, using flyers, partner-supported distribution of study information, and email announcements. Interested individuals will complete an online eligibility screener accessed through a QR code or URL on recruitment materials. Eligible participants will include women with an Edinburgh Postnatal Depression Scale score of 5-13 who have a planned singleton cesarean delivery, are within 18-45 years of age, and have no chronic pain condition. Individuals who meet initial eligibility criteria will be contacted by phone to confirm participant authenticity, then sent a REDCap link to complete electronic consent and a background questionnaire. After enrollment, participants will meet briefly with a trained research assistant to review access to the intervention platform and address any questions or concerns. Recruitment and enrollment will occur during the third trimester of pregnancy, and the intervention will begin during the first week following cesarean delivery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sandraluz Lara-Cinisomo, Ph.D.
- Telefonnummer: 217-300-3512
- E-post: laracini@illinois.edu
Studiesteder
-
-
Illinois
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Champaign, Illinois, Forente stater, 61820
- Rekruttering
- University of Illinois Urbana-Champaign
-
Ta kontakt med:
- Sandraluz Lara-Cinisomo, Ph.D
- Telefonnummer: 217-300-3512
- E-post: laracini@illinois.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
- Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White.
- Scheduled to undergo a planned cesarean delivery.
- Be of 18-45 years of age
- Have a singleton pregnancy
- Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
- A history of depression
- Have no chronic pain condition (e.g., fibromyalgia)
- Own a computer, smartphone, or tablet
- Have a reliable internet access to complete the online surveys.
- Be proficient in English or Spanish.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Mindfulness
Receiving mobile, self-guided mindfulness intervention
|
Meditation training to help reduce stress and reactivity to pain and other stressors.
Andre navn:
|
|
Ingen inngripen: Treatment as usual with monitoring
Receiving treatment as usual with monitoring by study PI and investigators.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-operative pain
Tidsramme: 1 week postpartum and 8 weeks postpartum
|
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
|
1 week postpartum and 8 weeks postpartum
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Postpartum depression
Tidsramme: 1 week postpartum and 8 weeks postpartum
|
Edinburgh Postnatal Depression Scale (EPDS); participant reported depressive symptoms.
Those who score above 13 are likely to be suffering from a depressive illness of varying severity.
|
1 week postpartum and 8 weeks postpartum
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Psykiske lidelser
- Postoperative komplikasjoner
- Patologiske prosesser
- Atferdssymptomer
- Stemningsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Smerte
- Smerter, postoperativt
- Depresjon
- Depressiv lidelse
- Atferdsterapi
- Psykoterapi
- Atferdsdisipliner og aktiviteter
- Kognitiv atferdsterapi
- Mindfulness
Andre studie-ID-numre
- MaMiDaPP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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