Mindfulness in Pregnancy

Study Overview
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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.

Official Title
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The Effect of an Auditory Mindfulness Intervention During NST Appointments on Depression and Anxiety in Pregnant Women

Conditions
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Anxiety, Depression, Mindfulness

Intervention / Treatment
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* Behavioral: Mindfulness Auditory Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Intervention Group<br>Participants in this group will listen to a short mindfulness audio clip during 6 of their NST appointments. | Behavioral: Mindfulness Auditory Intervention<br>* 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.<br>|
| No Intervention: Control Group<br>Participants in this group will have the regular standard of care for their NST appointments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory Score | We are looking for the members of our intervention group to see a change in their scores on the Beck Anxiety Inventory after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the full-course of the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure anxiety symptoms, and total scores range from 0-36. Lower scores indicate lower levels of anxiety symptoms, and thus a better outcome. | Over the course of 6 intervention sessions, followed by 6 weeks postpartum | 
| Edinburgh Postnatal Depression Scale Score | We are looking for the members of our intervention group to see a change in their scores on the Edinburgh Postnatal Depression Scale after completing 6 sessions of listening to a mindfulness clip. We expect to see this score change after the intervention is complete. We also hope to see this change in score persist at the 6-week postpartum visit. This scale aims to measure depressive symptoms, and total scores range from 0-30. Lower scores indicate lower levels of depressive symptoms, and thus a better outcome. | Over the course of 6 intervention sessions, followed by 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Mindfulness, Anxiety, Depression, NST, Non-stress test