Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

NCT ID: NCT05400382

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-03-31

Brief Summary

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This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Detailed Description

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This clinical trial will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Conditions

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Depression, Unipolar Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness

Receiving mobile, self-guided mindfulness intervention

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Meditation training to help reduce stress and reactivity to pain and other stressors.

Treatment as usual with monitoring

Receiving treatment as usual with monitoring by study PI and investigators.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness

Meditation training to help reduce stress and reactivity to pain and other stressors.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness meditation

Eligibility Criteria

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Inclusion Criteria

* 18-45 years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish

Exclusion Criteria

* Women who screen 10 or higher on the EPDS
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Southern Illinois University

OTHER

Sponsor Role collaborator

Arrowhead Regional Medical Center

OTHER

Sponsor Role collaborator

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Sandraluz Lara-Cinisomo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sandraluz Lara-Cinisomo, Ph.D.

Role: CONTACT

217-300-3512

Other Identifiers

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MaMiDaPP

Identifier Type: -

Identifier Source: org_study_id

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