Mindfulness in Pregnancy

NCT ID: NCT03635697

Last Updated: 2025-07-18

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

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-01-25

Brief Summary

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This study aims to determine if a short audio clip about mindfulness implemented during NST appointments can lower pregnant women's levels of anxiety and depression. Subjects will be placed into either the intervention group or a control group. The intervention group will be asked to listen to a short audio clip on mindfulness during their NST appointments, and the control group will receive the standard of care during NST appointments. Subjects will be asked to take two surveys about anxiety and depression three times throughout the study: before the intervention, after the intervention, and 6 weeks postpartum.

Detailed Description

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Conditions

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Anxiety Depression Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness Intervention Group

Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments.

Group Type EXPERIMENTAL

Mindfulness Auditory Intervention

Intervention Type BEHAVIORAL

This intervention is a short audio clip that focuses on the practices and principles of mindfulness. The goal of mindfulness is to bring awareness to a person's physical body as well as their thoughts and feelings.

Control Group

Participants in this group will have the regular standard of care for their NST appointments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness Auditory Intervention

This intervention is a short audio clip that focuses on the practices and principles of mindfulness. The goal of mindfulness is to bring awareness to a person's physical body as well as their thoughts and feelings.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* English as primary language
* less than 36 weeks gestational age
* at least 28 weeks gestational age

Exclusion Criteria

* Use of psychoactive medications
* Any psychiatric diagnosis with dissociative, hallucinatory, and/or delusional features
* History of suicide attempt or current suicidal ideations
* Uncontrolled substance abuse in the last 6 months
* Patients with hearing loss
* More than three no-shows to NST appointments
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher M Morosky, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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UConn Health / John Dempsey Hospital

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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18-226-1

Identifier Type: -

Identifier Source: org_study_id

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