跳至主要内容
临床试验/NCT06353243
NCT06353243招募中不适用

Pilot of the Bilateral Infant Stimulation Study (BLISS): A Parent Provided Positive-Touch Intervention Targeting Stress in the Neonatal Intensive Care Unity (NICU)

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Parental distress

研究概览

简要总结

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

详细描述

Objectives:

  1. Examine the effect of a bilateral alternating stimulation (BAS) NICU intervention on parental anxiety and psychological distress in the NICU using biological and self-report measurements.
  2. Examine the effect of a bilateral alternating stimulation NICU intervention on infants' physiological stress response after parental engagement in the BAS intervention with the infant.

This is a pilot study of bilateral alternating stimulation (BAS) examining the effectiveness as a therapeutic intervention for parental and infant stress in the NICU. It is a single arm design. Participants include parents and their infant that is currently admitted to the NICU. All participants will engage in parent-neonate intervention session, following this, infants will complete a delayed comparison arm (control session) with the interventionist. Infants currently admitted to NICU will be screened for eligibility, and if eligible, the families will be approached for enrollment. Families that enroll will be scheduled for one study session. During study session, parents will wear a heart rate monitor, complete psychologic scales of anxiety, stress, and feelings of closeness to thier infant, parents will be trained on the intervention and then engage in the intervention with their infant. Continuous vital signs will be collected for infant throughout the study session. After the intervention, parents will complete psychologic scales and satisfaction scales. Infants will then be scheduled for follow-up session where an interventionist will engage infant in intervention and vital signs will be collected throughout.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •admitted to the NICU at the time of study
  • •greater than 34 weeks gestational age and less than 43 weeks gestational age
  • •within 4 weeks of admission to NICU at time of initial contact
  • •have parent or legal guardian willing and able to participate in the study

排除标准

  • •those who are less than 3 days postop from surgical procedures
  • •current use of psychotropic medications or medications that affect the central nervous system (CNS)
  • •CNS anomaly.

研究组 & 干预措施

Bilateral alternating Stimulation

Experimental

positive touch intervention provided by parent to infant using alternating stimulation

干预措施: Bilateral alternating stimulation (Behavioral)

结局指标

主要结局

Parental distress

时间窗: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention

Distress Thermometer

Physiologic stress response

时间窗: total length of recording approximately 20 minutes for each participate, analysis will look at several minute epochs prior to and following intervention

heart rate variability variable- the root mean square of successive differences (RMSSD) which reflects vagal tone

Parental anxiety

时间窗: Administered immediately prior to engagement in study intervention activities and within 2 minutes post intervention

Visual Analog Scale- Anxiety (VAS-A). The VAS scale asks participants to rate current anxiety on a horizontal line ranging from "calm" and "anxious" with scores between 0-100, with higher scores indicating higher levels of anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristen Mackiewicz Seghete

Principle Investigator

Oregon Health and Science University

研究点 (1)

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