Yoga in the NICU for Parents (YiN): a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Measure of NICU parent stress
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measure of NICU parent stress
时间窗: 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.
Change in parental depression, anxiety and stress score over time
时间窗: 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.
Measure of parent-child bonding
时间窗: 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.
次要结局
- Length of assisted ventilation (days)(From date of admission through discharge home or transfer to another institution, up to a maximum of 32 weeks.)
- Yoga class participation(From randomization through the conclusion of the 6-week study period)
- Infant Length of Stay(From date of admission until infant discharge home or transfer to another institution, up to a maximum of 32 weeks.)
- Duration of participation in yoga classes(From randomization through the conclusion of the 6-week study period)
- Parent Satisfaction with Yoga Intervention(Once after 6-weeks at the conclusion of the study)
- Breastfeeding at discharge(At the date of discharge to home, up to a maximum of 32 weeks.)
- Postpartum Depression(Up to 4 weeks after admission)
研究者
Sara Neches
Principal Investigator
Seattle Children's Hospital