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临床试验/NCT07410923
NCT07410923已完成不适用

The Effect of Short Film and Video-Based Education on the Intensive Care Unit Introduction for Parents of Premature Infants on Stress, Care Participation, and Satisfaction Levels

Mersin University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年2月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Parental Stress Levels at T0

研究概览

简要总结

The primary objective of this single-center, parallel-group, randomized controlled experimental study is to evaluate the effect of short film and video-based education on the intensive care unit orientation provided to parents of premature infants, specifically assessing its impact on stress levels as the primary outcome and satisfaction and level of involvement in care as secondary outcomes. Using the block randomization method, 72 parents will be assigned to three different groups ("Routine Care" n=24, "Routine Care + Short Film-based Education" n=24, "Routine Care + Video-based Education" n=24).

Research Hypotheses:

Primary Hypothesis:

H1/1: There is a difference between the mean stress scores of parents by group.

Secondary Hypotheses:

H1/2: There is a difference between the mean scores of parents' participation in care according to groups.

H1/3: There is a difference between the mean scores of parents' satisfaction according to groups.

详细描述

The primary objective of this single-center, parallel-group, randomized controlled experimental study is to evaluate the effect of short film and video-based education on the intensive care unit orientation provided to parents of premature infants, specifically assessing its impact on stress levels as the primary outcome and satisfaction and level of involvement in care as secondary outcomes. Using the block randomization method, 72 parents will be assigned to three different groups ("Routine Care" n=24, "Routine Care + Short Film-based Education" n=24, "Routine Care + Video-based Education" n=24).

Research Hypotheses:

Primary Hypothesis:

H1/1: There is a difference between the mean stress scores of parents by group.

Secondary Hypotheses:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to use a smartphone
  • Access to the internet
  • Willingness to participate in the study
  • Gestational age of the baby is less than 37 weeks
  • The baby has been newly admitted to the neonatal intensive care unit
  • The baby is expected to remain in the unit for at least another week
  • The baby's general condition is stable

排除标准

  • Having intellectual limitations
  • Having a mental health issue
  • Having a baby with a major congenital anomaly or defect
  • Having a baby in the terminal stage

研究组 & 干预措施

Routine Care

Active Comparator

verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment

干预措施: routine care (Other)

Short Film-Based Education

Experimental

Short Film-Based Education + verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment

干预措施: Short Film-Based Education (Behavioral)

Video-Based Education

Experimental

Video-Based Education + verbal information about baby's general condition, treatment process, unit environment, rules, medical equipment and devices, healthcare team, basic procedures, etc. + showing and introducing the baby and the NICU environment

干预措施: Video-based Education (Behavioral)

结局指标

主要结局

Parental Stress Levels at T0

时间窗: The baby's admission to the neonatal intensive care unit within 48-72 hours

PSS:NICU is a 5-point Likert scale consisting of three dimensions and a total of 34 items. The dimensions are "Visual and Auditory Stimuli (6 items)" in the unit, the baby's "Appearance and Behavior (17 items)", and the parent's "Relationship and Roles (11 items)". It is scored on a scale of "1 = Not at all stressed...5 = Extremely stressed." A higher scale score indicates an increase in parental stress levels.

Parental Stress Levels at T1

时间窗: The seventh to tenth days of the baby's admission to the neonatal intensive care unit

PSS:NICU is a 5-point Likert scale consisting of three dimensions and a total of 34 items. The dimensions are "Visual and Auditory Stimuli (6 items)" in the unit, the baby's "Appearance and Behavior (17 items)", and the parent's "Relationship and Roles (11 items)". It is scored on a scale of "1 = Not at all stressed...5 = Extremely stressed." A higher scale score indicates an increase in parental stress levels.

次要结局

  • Participation in Care by EMPATHIC-N at T0(The baby's admission to the neonatal intensive care unit within 48-72 hours)
  • Participation in Care by EMPATHIC-N at T1(The seventh to tenth days of the baby's admission to the neonatal intensive care unit)
  • Parental Satisfaction at T0(The baby's admission to the neonatal intensive care unit within 48-72 hours)
  • Parental Satisfaction at T1(The seventh to tenth days of the baby's admission to the neonatal intensive care unit)

研究者

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

Guzide UGUCU

Res. Asst., RN, MScN, PhD

Mersin University

研究点 (1)

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