Yoga in the NICU for Parents Study (YiN)
Primary Purpose
Postpartum Depression, Anxiety, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
yoga classes
Sponsored by
About this trial
This is an interventional other trial for Postpartum Depression focused on measuring yoga, meditation
Eligibility Criteria
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
Sites / Locations
- Seattle Children's HospitalRecruiting
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Yoga Group
Arm Description
Parents will experience usual care including all available parental support as practiced in the specific site NICU.
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).
Outcomes
Primary Outcome Measures
Change in parental depression, anxiety and stress score over time
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.
Measure of NICU parent stress
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.
Measure of parent-child bonding
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.
Secondary Outcome Measures
Infant Length of Stay
Length of stay (days) from admission to discharge home or transfer to other institution, as documented on the discharge or transfer summary.
Length of assisted ventilation (days)
Length of time (days) that infant required either invasive or non-invasive ventilation, as documented on the discharge or transfer summary.
Breastfeeding at discharge
Documentation of whether infant is doing any breastfeeding at discharge (yes/no) as documented on the discharge summary.
Yoga class participation
Participation in the yoga intervention will be tracked on the study website to assess number of sessions started (n)
Duration of participation in yoga classes
Participation in the yoga intervention will be tracked on the study website to assess duration of participation (minutes).
Postpartum Depression
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.
Parent Satisfaction with Yoga Intervention
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.
Full Information
NCT ID
NCT05322161
First Posted
March 3, 2022
Last Updated
June 18, 2023
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT05322161
Brief Title
Yoga in the NICU for Parents Study
Acronym
YiN
Official Title
Yoga in the NICU for Parents (YiN): a Clinical Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Anxiety, Depression, Stress Disorder, Prematurity
Keywords
yoga, meditation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group receives standard of care for parent support. Interventional group receives virtual yoga classes in addition to standard of care for parent support.
Masking
Investigator
Masking Description
Investigator is blinded to study allocation (yoga or control group) prior to enrollment. Once participant is randomized the investigator will know which group the participant is in.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents will experience usual care including all available parental support as practiced in the specific site NICU.
Arm Title
Yoga Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
yoga classes
Intervention Description
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:
Yoga postures (Asana) = low impact gentle postures meant to be done individually
Breathing techniques (Pranayama) = deliberate modifications of breath such as rapid diaphragmatic breathing, slow/deep breathing, alternate nostril breathing, breath holding
Meditation (Dhyana) = guided meditation
Primary Outcome Measure Information:
Title
Change in parental depression, anxiety and stress score over time
Description
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.
Time Frame
Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
Title
Measure of NICU parent stress
Description
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.
Time Frame
Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
Title
Measure of parent-child bonding
Description
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.
Time Frame
Once after 6-weeks at the conclusion of the study
Secondary Outcome Measure Information:
Title
Infant Length of Stay
Description
Length of stay (days) from admission to discharge home or transfer to other institution, as documented on the discharge or transfer summary.
Time Frame
From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks.
Title
Length of assisted ventilation (days)
Description
Length of time (days) that infant required either invasive or non-invasive ventilation, as documented on the discharge or transfer summary.
Time Frame
From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.
Title
Breastfeeding at discharge
Description
Documentation of whether infant is doing any breastfeeding at discharge (yes/no) as documented on the discharge summary.
Time Frame
At the date of discharge to home, up to a maximum of 32 weeks.
Title
Yoga class participation
Description
Participation in the yoga intervention will be tracked on the study website to assess number of sessions started (n)
Time Frame
From randomization through the conclusion of the 6-week study period
Title
Duration of participation in yoga classes
Description
Participation in the yoga intervention will be tracked on the study website to assess duration of participation (minutes).
Time Frame
From randomization through the conclusion of the 6-week study period
Title
Postpartum Depression
Description
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.
Time Frame
Up to 4 weeks after admission
Title
Parent Satisfaction with Yoga Intervention
Description
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.
Time Frame
Once after 6-weeks at the conclusion of the study
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara K Neches, MD
Phone
206-884-8517
Email
skneches@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Juul, MD, PhD
Phone
206-221-6814
Email
sjuul@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Neches, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeenia Billimoria, MD
Email
zeenia.billimoria@seattlechildrens.org
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirtikumar Upadhyay, MD
Email
kupadhya@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
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Citation
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Yoga in the NICU for Parents Study
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