Yoga in the NICU for Parents Study

NCT05322161 | Completed

• 2 other identifiers: STUDY00003325SITE00001252
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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).

Conditions

Postpartum Depression; Anxiety; Depression; Stress Disorder; Prematurity

Keywords

yoga; meditation

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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 Outcomes (7)

• Infant Length of Stay

  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)

  From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.

• Breastfeeding at discharge

  At the date of discharge to home, up to a maximum of 32 weeks.

• Yoga class participation

  From randomization through the conclusion of the 6-week study period

• Duration of participation in yoga classes

  From randomization through the conclusion of the 6-week study period

Study Arms (2)

Control

NO INTERVENTION

Parents will experience usual care including all available parental support as practiced in the specific site NICU.

Yoga Group

EXPERIMENTAL

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

Interventions

yoga classes BEHAVIORAL

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

Yoga Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (2)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (15)

• Treyvaud K, Spittle A, Anderson PJ, O'Brien K. A multilayered approach is needed in the NICU to support parents after the preterm birth of their infant. Early Hum Dev. 2019 Dec;139:104838. doi: 10.1016/j.earlhumdev.2019.104838. Epub 2019 Aug 27.

  PMID: 31471000 BACKGROUND

• Yaari M, Treyvaud K, Lee KJ, Doyle LW, Anderson PJ. Preterm Birth and Maternal Mental Health: Longitudinal Trajectories and Predictors. J Pediatr Psychol. 2019 Jul 1;44(6):736-747. doi: 10.1093/jpepsy/jsz019.

  PMID: 30977828 BACKGROUND

• Pace CC, Spittle AJ, Molesworth CM, Lee KJ, Northam EA, Cheong JL, Davis PG, Doyle LW, Treyvaud K, Anderson PJ. Evolution of Depression and Anxiety Symptoms in Parents of Very Preterm Infants During the Newborn Period. JAMA Pediatr. 2016 Sep 1;170(9):863-70. doi: 10.1001/jamapediatrics.2016.0810.

  PMID: 27428766 BACKGROUND

• Winter L, Colditz PB, Sanders MR, Boyd RN, Pritchard M, Gray PH, Whittingham K, Forrest K, Leeks R, Webb L, Marquart L, Taylor K, Macey J. Depression, posttraumatic stress and relationship distress in parents of very preterm infants. Arch Womens Ment Health. 2018 Aug;21(4):445-451. doi: 10.1007/s00737-018-0821-6. Epub 2018 Mar 3.

  PMID: 29502280 BACKGROUND

• Moehler E, Brunner R, Wiebel A, Reck C, Resch F. Maternal depressive symptoms in the postnatal period are associated with long-term impairment of mother-child bonding. Arch Womens Ment Health. 2006 Sep;9(5):273-8. doi: 10.1007/s00737-006-0149-5. Epub 2006 Sep 8.

  PMID: 16937313 BACKGROUND

• Treyvaud K, Anderson VA, Lee KJ, Woodward LJ, Newnham C, Inder TE, Doyle LW, Anderson PJ. Parental mental health and early social-emotional development of children born very preterm. J Pediatr Psychol. 2010 Aug;35(7):768-77. doi: 10.1093/jpepsy/jsp109. Epub 2009 Dec 2.

  PMID: 19955253 BACKGROUND

• Treyvaud K, Anderson VA, Howard K, Bear M, Hunt RW, Doyle LW, Inder TE, Woodward L, Anderson PJ. Parenting behavior is associated with the early neurobehavioral development of very preterm children. Pediatrics. 2009 Feb;123(2):555-61. doi: 10.1542/peds.2008-0477.

  PMID: 19171622 BACKGROUND

• Kerstis B, Aarts C, Tillman C, Persson H, Engstrom G, Edlund B, Ohrvik J, Sylven S, Skalkidou A. Association between parental depressive symptoms and impaired bonding with the infant. Arch Womens Ment Health. 2016 Feb;19(1):87-94. doi: 10.1007/s00737-015-0522-3. Epub 2015 Apr 10.

  PMID: 25854998 BACKGROUND

• de Cock ESA, Henrichs J, Klimstra TA, Janneke B M Maas A, Vreeswijk CMJM, Meeus WHJ, van Bakel HJA. Longitudinal Associations Between Parental Bonding, Parenting Stress, and Executive Functioning in Toddlerhood. J Child Fam Stud. 2017;26(6):1723-1733. doi: 10.1007/s10826-017-0679-7. Epub 2017 Feb 27.

  PMID: 28572718 BACKGROUND

• Trkulja V, Baric H. Current Research on Complementary and Alternative Medicine (CAM) in the Treatment of Anxiety Disorders: An Evidence-Based Review. Adv Exp Med Biol. 2020;1191:415-449. doi: 10.1007/978-981-32-9705-0_22.

  PMID: 32002940 BACKGROUND

• Cramer H, Lauche R, Anheyer D, Pilkington K, de Manincor M, Dobos G, Ward L. Yoga for anxiety: A systematic review and meta-analysis of randomized controlled trials. Depress Anxiety. 2018 Sep;35(9):830-843. doi: 10.1002/da.22762. Epub 2018 Apr 26.

  PMID: 29697885 BACKGROUND

• Cramer H, Anheyer D, Saha FJ, Dobos G. Yoga for posttraumatic stress disorder - a systematic review and meta-analysis. BMC Psychiatry. 2018 Mar 22;18(1):72. doi: 10.1186/s12888-018-1650-x.

  PMID: 29566652 BACKGROUND

• Cramer H, Anheyer D, Lauche R, Dobos G. A systematic review of yoga for major depressive disorder. J Affect Disord. 2017 Apr 15;213:70-77. doi: 10.1016/j.jad.2017.02.006. Epub 2017 Feb 7.

  PMID: 28192737 BACKGROUND

• Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.

  PMID: 16673041 BACKGROUND

• Matthey S, Barnett B, Kavanagh DJ, Howie P. Validation of the Edinburgh Postnatal Depression Scale for men, and comparison of item endorsement with their partners. J Affect Disord. 2001 May;64(2-3):175-84. doi: 10.1016/s0165-0327(00)00236-6.

  PMID: 11313084 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Depression; Stress Disorders, Traumatic; Premature Birth

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Sara Neches, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group receives standard of care for parent support. Interventional group receives virtual yoga classes in addition to standard of care for parent support.

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: April 11, 2022
• Study Start: September 29, 2021
• Primary Completion: October 12, 2023
• Study Completion: January 31, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: beginning 3 months and ending 5 years following the article publication
• Access Criteria: Proposals should be directed to skneches@uw.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)