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Идёт набор NCT06252883

Impact of Serial Bedside Video Calls on Stress Level in Parents of Infants Admitted to NICU

Без фазы С лечением Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Serial bedside video call communication.
Кому может быть актуально
Состояния в реестре: Stress. Базовые параметры: 7 Days — 60 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Impact of Serial Bedside Video Call Communication on Stress Level in Parents of Infants Admitted to NICU.

Обзор

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.

Подробное описание

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):

PSS-NICU

Assessment 3 (6-8 weeks of life):

MSPSS, PSS-NICU, STAI Y-1, STAI Y-2

Socio-demographic data

Infant Clinical severity Score: This quantifies the degree of infant clinical severity at the time of assessment for our study. This score is not intended to portray mortality or morbidity.

Multidimensional Scale of Perceived Social support (MSPSS)

Parental stressor Scale- Neonatal Intensive Care unit (PSS-NICU) 3 subtype

State- Trait-Anxiety-Inventory Form Y-1 - is a well validated form used to measure one's anxiety state at a specific moment in time.

State- Trait-Anxiety-Inventory Form Y-2 - is a well validated tool that requires the individual to describe how they generally feel.

Вмешательства

  • Другое Serial bedside video call communication
    Bedside video call with audio features, given to NICU parent/guardian 2-3 days a week for an 8-week period or till infant is discharged, whichever comes first.

Первичные конечные точки

  • Change in the stress level of parents of infants admitted to NICU more than 7 days. [Срок оценки: 8 weeks after infant's enrollment or till infant is discharged, whichever comes first.]
Вторичные конечные точки (5)
  • Assess other contributing factors to parental stress such as anxiety. (Exploratory) [Срок оценки: From date of enrollment to date of last assessment, assessed up to 8weeks.]
  • Parental anxiety state at discharge time (Exploratory) [Срок оценки: From date of enrollment to date of last assessment, assessed up to 8weeks.]
  • Assess other contributing factors to parental stress such as perceived support system. (Exploratory) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From date of enrollment to date of last assessment, assessed up to 8weeks.]

Критерии участия

Критерии включения

\- Newborns with 7 days or more of NICU stay

Exclusion Criteria: Infant with

  • intrauterine drug exposure
  • major critical congenital cardiac anomaly
  • major neurologic anomaly
  • chromosomal disorder.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • John H. Stroger Hospital of Cook County — Chicago

Публикации

  • Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52. PMID 8506163
  • Greene MM, Rossman B, Patra K, Kratovil AL, Janes JE, Meier PP. Depression, anxiety, and perinatal-specific posttraumatic distress in mothers of very low birth weight infants in the neonatal intensive care unit. J Dev Behav Pediatr. 2015 Jun;36(5):362-70. doi: 10.1097/DBP.0000000000000174. PMID 26039191
  • Ionio C, Mascheroni E, Colombo C, Castoldi F, Lista G. Stress and feelings in mothers and fathers in NICU: identifying risk factors for early interventions. Prim Health Care Res Dev. 2019 Jun 7;20:e81. doi: 10.1017/S1463423619000021. PMID 32799977
  • Okito O, Yui Y, Wallace L, Knapp K, Streisand R, Tully C, Fratantoni K, Soghier L. Parental resilience and psychological distress in the neonatal intensive care unit. J Perinatol. 2022 Nov;42(11):1504-1511. doi: 10.1038/s41372-022-01478-3. Epub 2022 Aug 4. PMID 35927487
  • Gibson R, Kilcullen M. The Impact of Web-Cameras on Parent-Infant Attachment in the Neonatal Intensive Care Unit. J Pediatr Nurs. 2020 May-Jun;52:e77-e83. doi: 10.1016/j.pedn.2020.01.009. Epub 2020 Feb 1. PMID 32014335

Идентификаторы

NCT: NCT06252883 · 24-004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗