Yoga in the NICU for Parents Study (YiN)

May 16, 2024 updated by: Sara Neches, Seattle Children's Hospital

Yoga in the NICU for Parents (YiN): a Clinical Pilot Study

The purpose of this proposal is to test the efficacy of yoga as a mind and body intervention to decrease stress, anxiety, and depression in parents of critically ill neonates hospitalized in the Seattle Children's and University of Washington neonatal intensive care units (NICUs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preterm infants are often critically ill and require prolonged hospitalization in neonatal intensive care units (NICUs). The care of these infants is often regionalized so that specialized treatment can be performed in centers with specific expertise. An unintended consequence of regionalization of care is the physical and emotional isolation parents experience when a child is hospitalized far from family, friends, and work. As a result of these stressors, loss of parental control, autonomy, and concern for a child's wellbeing, nearly half of NICU mothers develop anxiety, depression, or posttraumatic stress disorder, and this may persist for years.

Helping parents cope with the birth and hospitalization of a preterm infant is critical for the parents' health and wellbeing, as well as for the optimal development of the child, as parental anxiety and depression may affect parent-child bonding and result in altered child development. The practice of yoga, which encompasses physical postures (asana), but also includes breathing techniques (pranayama), and meditation (dhyana), has proven benefits in many areas of medicine and wellness including stress management, mental and emotional health and promoting sleep. Given the positive effects on both physical and emotional health, these mind and body techniques are promising as a therapeutic modality by which parental stress, anxiety and depression could be reduced.

This study is unique in that previous studies of yoga have not occurred in hospital settings and have not included subjects in an acute state of distress such as parents of critically ill hospitalized neonates. Furthermore, in the current COVID-19 environment it is important to explore ways to make yoga interventions available to families by remote access, and to test whether this approach is successful.

This will be a randomized controlled pilot study to elucidate the optimal research strategy with which to implement mind and body interventions for parents of NICU patients, at two sites (University of Washington NICU and Seattle Children's Hospital NICU). We aim to enroll 40 NICU mothers and any of their interested partners in the study. We will approach parents after day 10 of infant admission to NICU and begin participation by day 14 of NICU admission.

The investigators hypothesize that a combined program of breath work, physical practice and meditation will decrease parental stress, anxiety, and depression in the NICU.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • NICU inpatients born <32 weeks gestation at birth and/or <1500g, OR estimated length of stay ≥6 weeks
  • Parents of current NICU inpatients born <32 weeks gestation at birth and/or <1500g OR estimated length of stay ≥6 weeks
  • Parents with any level of experience with yoga (none to regular practitioner)
  • Child has been admitted to the NICU for at least 10 days
  • Parent age ≥18 years
  • Parent speaks and reads in either English or Spanish

Exclusion Criteria:

  • Expected length of stay of NICU inpatient <6 weeks
  • Parent does not speak or read in English only speaks or reads in a language other than English or Spanish
  • Parent plans to relinquish child
  • Child or parents are too unstable as assessed by the Attending Physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Parents will experience usual care including all available parental support as practiced in the specific site NICU.
Experimental: Yoga Group
In addition to usual care, the parents randomized to the intervention group will be provided a yoga mat and participate in 30-min online led yoga sessions done at least twice weekly at the parent's pace using a secure, virtual platform (website).
Behavioral: yoga classes

There will be 6 total yoga classes (one introduced per week for a 6 week period). Each yoga session will be divided into three components, which will vary in duration based on a curriculum designed specifically with the post-partum state of mothers in mind:

  1. Yoga postures (Asana) = low impact gentle postures meant to be done individually
  2. Breathing techniques (Pranayama) = deliberate modifications of breath such as rapid diaphragmatic breathing, slow/deep breathing, alternate nostril breathing, breath holding
  3. Meditation (Dhyana) = guided meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parental depression, anxiety and stress score over time
Time Frame: Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
The depression, anxiety & stress scale (DASS-21) is validated in English and Spanish and is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three sub scales (depression, anxiety and stress) contain 7 questions with answers valued on a scale of 0-3. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Each sub scale score is multiplied by 2 and totaled to generate a DASS 21 score. Analysis will include mean/SD and median of total score and comparison of median DASS 21 score between pre and post-intervention. A high score on the DASS 21 means worse depression, anxiety and stress.
Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
Measure of NICU parent stress
Time Frame: Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) is a 26-item self-report scale designed to measure the degree of stress experienced by parents during hospitalization. This scale has been validated in multiple languages including English and Spanish. Analysis will assess parents' overall level of stress engendered by the NICU environment. All individuals receive a score on each item, with those not having the experience (e.g N/A) receiving a "1" indicating no stress was experienced. Score will be generated by a total sum of: sub scale 1: Sights and Sounds (sum/5)+ sub scale 2: Infant behavior and appearance (sum/14)+ sub scale 3: Parental Role Alteration (sum/7). Analysis to include: mean/SD for each sub scale and mean/SD for total score for each participant. Mean scores on the PSS:NICU will be compared across the three time-points and between parents in each arm (intervention and control). A higher score on the PSS:NICU means higher NICU parent stress.
Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
Measure of parent-child bonding
Time Frame: Once after 6-weeks at the conclusion of the study
Postpartum Bonding Questionnaire (PBQ) was developed to detect mother-infant bonding disturbances in the postnatal period. Participants rate how often they agree with statements on a 6-point Likert scale ranging from always (score 0) to never (score 5) with low scores denoting good bonding. We plan to use 2 of the four sub scales (19-item self-report scale). A score of >/= 12 on scale 1 and >/= 13 on scale 2 indicates worse parent-child bonding.
Once after 6-weeks at the conclusion of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent Satisfaction with Yoga Intervention
Time Frame: Once after 6-weeks at the conclusion of the study
Course completion study filled out by all participants at the conclusion of the study. There will be specific questions geared to the intervention group to qualitatively assess parent satisfaction with the yoga intervention.
Once after 6-weeks at the conclusion of the study
Infant Length of Stay
Time Frame: From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks.
Length of stay (days) from admission to discharge home or transfer to other institution, as documented on the discharge or transfer summary.
From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks.
Length of assisted ventilation (days)
Time Frame: From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.
Length of time (days) that infant required either invasive or non-invasive ventilation, as documented on the discharge or transfer summary.
From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.
Breastfeeding at discharge
Time Frame: At the date of discharge to home, up to a maximum of 32 weeks.
Documentation of whether infant is doing any breastfeeding at discharge (yes/no) as documented on the discharge summary.
At the date of discharge to home, up to a maximum of 32 weeks.
Yoga class participation
Time Frame: From randomization through the conclusion of the 6-week study period
Participation in the yoga intervention will be tracked on the study website to assess number of sessions started (n)
From randomization through the conclusion of the 6-week study period
Duration of participation in yoga classes
Time Frame: From randomization through the conclusion of the 6-week study period
Participation in the yoga intervention will be tracked on the study website to assess duration of participation (minutes).
From randomization through the conclusion of the 6-week study period
Postpartum Depression
Time Frame: Up to 4 weeks after admission
The Edinburgh Postnatal Depression Scale (EPDS) has been validated in both women and men, and consists of 10 questions. The total score is determined by adding together the scores for each of the 10 items. Cut-off scores ranged from 9 to13 points with higher scores indicating worse post-partum depression. EPDS is administered to mothers by the NICU social worker between day 10-14 of admission. Participating fathers will fill out an EPDS survey as part of enrollment in this study.
Up to 4 weeks after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

Investigators

  • Principal Investigator: Sara Neches, MD, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Actual)

October 12, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003325
  • SITE00001252 (Other Identifier: University of Washington)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported after de-identification (texts, tables, figures and appendices). Study protocol, statistical analysis plan and analytic code

IPD Sharing Time Frame

beginning 3 months and ending 5 years following the article publication

IPD Sharing Access Criteria

Proposals should be directed to skneches@uw.edu. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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