Clinical trial NCT05322161: Yoga in the NICU for Parents Study
Official title: Yoga in the NICU for Parents (YiN): a Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Anxiety
Depression
Stress Disorder
Prematurity
Keywords: yoga
meditation
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-04-11
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in parental depression, anxiety and stress score over time
timeFrame: Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
measure: Measure of NICU parent stress
timeFrame: Administered at three time points: At randomization, after 3-weeks in the study, after 6-weeks at the conclusion of the study
measure: Measure of parent-child bonding
timeFrame: Once after 6-weeks at the conclusion of the study
Secondary outcomes:
measure: Infant Length of Stay
timeFrame: From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks.
measure: Length of assisted ventilation (days)
timeFrame: From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.
measure: Breastfeeding at discharge
timeFrame: At the date of discharge to home, up to a maximum of 32 weeks.
measure: Yoga class participation
timeFrame: From randomization through the conclusion of the 6-week study period
measure: Duration of participation in yoga classes
timeFrame: From randomization through the conclusion of the 6-week study period
measure: Postpartum Depression
timeFrame: Up to 4 weeks after admission
measure: Parent Satisfaction with Yoga Intervention
timeFrame: Once after 6-weeks at the conclusion of the study
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Sara Neches, MD
role: PRINCIPAL_INVESTIGATOR
References:
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