Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in the stress level of parents of infants admitted to NICU more than 7 days.
研究概览
简要总结
The goal of this randomized prospective interventional study is to determine if serial bedside video calls w/audio feature to NICU parents in addition to the routine phone and/or bedside updates can reduce parental stress level. The main question it aims to answer is if the impact of audio-visual calls to nicu parents can improve parent-infant relationship in the form of reduced parental anxiety/stress level.
Participants will be parents of infants admitted to NICU for more than seven (7) days.
Parents in Group A will receive serial video call communication, 2-3 days a week in addition to the daily phone and/or bedside updates.
Parents in Group B will receive daily phone and/or bedside updates per our NICU routine.
Parents will complete a series of questionnaires (PSS-NICU, STAI Y-1 & 2 and MSPSS) at 3 designated periods during an 8-week time frame.
Researchers will compare Group A (intervention group) and Group B (control group) to see if there is any difference in the stress levels in relation to the intervention (serial video calls) at the end of the study time frame.
详细描述
The NICU can be a stressful environment for new mothers and fathers irrespective of whether NICU stay was anticipated or not. Parental role alteration remains one of the major parental stressors. Our NICU practices family centered care, with efforts to reduce NICU associated stress by daily updates (via phone and in person/by bedside), encouraging parent-infant skin to skin as infant's clinical state permits, allowing physical touch of baby with hands to stimulate bonding, amongst other practices. Studies have looked at stress as well as psychological distress in relation with parental resilience in the NICU, but none have looked at stress level in NICU parents in relation to their infant's clinical status at the time of assessment while adding an intervention. Our study, to the best of our knowledge, will be the first to evaluate the impact of serial bedside video call w/audio feature to NICU parents, permitting audio interaction with their infant, with an interval assessment of parent's stress level.
Parents will be randomized into 2 groups. The parent/guardian designated at the time of initial enrollment/consenting will be asked to complete the forms at subsequent assessments and participate in the study intervention. Data collection will be at 3 points during an 8-week period. Parental assessment will be done when they are visiting their infant. Parents will receive the following questionnaires during the 3 assessments and Infant clinical severity score will be completed at all assessments by the research investigator.
Assessment 1 (7-10 days of life):
Socio-demographic sheet, MSPSS, PSS-NICU
Assessment 2 (14-21 days of life):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Newborns with 7 days or more of NICU stay
排除标准
- •Infant with
- •intrauterine drug exposure
- •major critical congenital cardiac anomaly
- •major neurologic anomaly
- •chromosomal disorder.
研究组 & 干预措施
GROUP A (intervention group)
Parents in this group will receive bedside video call 2-3 days a week in addition to the routine NICU phone update and/or bedside update using the NICU iPad w/ "Doximity" app.
干预措施: Serial bedside video call communication (Other)
Group B (control group)
Parents in this group will receive the routine phone and/or bedside updates done in our NICU already without the intervention (serial video calls).
结局指标
主要结局
Change in the stress level of parents of infants admitted to NICU more than 7 days.
时间窗: 8 weeks after infant's enrollment or till infant is discharged, whichever comes first.
Statistical analysis of the questionnaire evaluating stress (PSS-NICU) at the 3 points of assessments during the study will be done and compared between the two groups for effect/impact of the intervention. 26 questions are rated on a 5 -point Likert scale to measure parental stress in 3 sub-areas of the questionnaire: Infant's appearance and behavior, Sights and sounds and Parental role alteration. Each scenario described is rated on a scale of 1("Not at all stressful") to 5 ("Extremely stressful") and the total score is then averaged to obtain the final score rated as 1 to 5 with higher scores indicative of high stress level.
次要结局
- Assess other contributing factors to parental stress such as perceived support system. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
- Assess other contributing factors to anxiety such as change in the infant's clinical condition (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
- Parental anxiety state at discharge time (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
- Assess other contributing factors to parental stress such as anxiety. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)
- Assess other contributing factors to anxiety such as parental demographic factors and socioeconomic status. (Exploratory)(From date of enrollment to date of last assessment, assessed up to 8weeks.)