Mindfulness to Reduce Post-cesarean Pain and Prevent Post... | NCT05400382

Studies
Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

NCT05400382

Sponsor

University of Illinois at Urbana-Champaign

Status

Unknown status

Last Update Posted

Jun 1, 2022Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Depression, Unipolar
Pain, Postoperative

Interventions

Mindfulness

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Estimated

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Mar 31, 2026Estimated

First Submitted Date

May 27, 2022

First Submission Date that Met QC Criteria

May 27, 2022

First Posted Date

Jun 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2022

Last Update Posted Date

Jun 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sandraluz Lara-Cinisomo, Associate Professor, University of Illinois at Urbana-ChampaignPrincipal Investigator

Lead Sponsor

University of Illinois at Urbana-ChampaignOTHER

Collaborators

Name	Class
University of Pittsburgh Medical Center	OTHER
Southern Illinois University	OTHER
Arrowhead Regional Medical Center	OTHER
Northwestern University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness	Experimental	Receiving mobile, self-guided mindfulness intervention	Behavioral: Mindfulness
Treatment as usual with monitoring	No Intervention	Receiving treatment as usual with monitoring by study PI and investigators.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness	Behavioral	Meditation training to help reduce stress and reactivity to pain and other stressors.	Mindfulness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postpartum depression	depressive symptoms EPDS 13 or higher	4 weeks - 6 months

Secondary Outcomes

Measure	Description	Time Frame
Post-operative pain	Post-cesarean delivery pain	4 weeks - 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Cis-gender women

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandraluz Lara-Cinisomo, Ph.D.	Contact	217-300-3512		laracini@illinois.edu

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

To be determined

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D010149	Pain, Postoperative
D003863	Depression
D010146	Pain

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D064866	Mindfulness

Ancestor Terms

ID	Term
D015928	Cognitive Behavioral Therapy
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided