Yoga in the NICU for Parents Study (YiN)

Seattle Children's Healthcare System logo

Seattle Children's Healthcare System

Status

Completed

Conditions

Prematurity
Stress Disorder
Depression
Anxiety
Postpartum Depression

Treatments

Behavioral: yoga classes

Study type

Interventional

Funder types

Other

Identifiers

NCT05322161
STUDY00003325
SITE00001252 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

51 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups

Control
No Intervention group
Description:
Parents will experience usual care including all available parental support as practiced in the specific site NICU.
Yoga Group
Experimental group
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).
Treatment:
Behavioral: yoga classes

Trial documents
1

Trial contacts and locations

2

Loading...

Central trial contact

Sandra Juul, MD, PhD; Sara K Neches, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems