Therapeutic Cuddling in Critically Ill Children

Официальное название

Therapeutic Cuddling in Critically Ill Kids (THE ChICKS) Pilot Feasibility Randomized Controlled Trial

Обзор

2.1 CONTEXT Pain and agitation are common comorbidities of pediatric critical illness due to both underlying disease processes and ICU related therapies. These are associated with both short and long term negative sequelae including increased mortality, length of stay, rates of ICU delirium, worse sleep, increased anxiety, depression, and chronic pain. The current standard of care to manage PICU associated pain and agitation is the use of analgosedation (e.g. opioids and benzodiazepines) these too are associated with increased time on the ventilator, length of stay, ICU delirium, and long term mental health and negative neuro-cognitive outcomes. Despite recommendations for increased use of non-pharmacologic therapies in the prevention and management of PICU associated pain, agitation, delirium, and analgosedation exposure, there are currently know therapies with clear evidence of efficacy. Therapeutic cuddling (e.g. kangaroo care, clothed cuddling, comfort holding, etc.) has been shown to decrease pain and anxiety in critically ill neonates, and healthy children and adults. Positive affective touch and hugging has known physiologic benefits and has been associated with decreased pain, improved immunity, and decreased mortality. Despite the potential for this intervention to aid in the prevention and management of PICU associated pain, agitation, delirium and analgosedation exposure, little data exists on efficacy of therapeutic cuddling in critically ill children. 2.2 OBJECTIVES 2.2.1 Primary Determine the feasibility of screening, consent, randomization, and retention of participants in a pragmatic RCT of therapeutic cuddling versus standard of care in the Alberta Children's Hospital Pediatric Intensive Care Unit. 2.2.2 Secondary 1. Determine treatment fidelity of participants randomized to the intervention arm. 2. Determine the prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm. 3. Determine the feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence). 4. Describe the experience of patients, caregivers, and healthcare professionals in delivering/receiving the therapeutic cuddling intervention. 2.3 STUDY DESIGN Pilot feasibility randomized controlled trial of a structured co-designed therapeutic cuddling intervention as compared to the standard of care in a single tertiary care PICU. 2.4 DURATION 6 months to 1 year 2.5 LOCATION, DEPARTMENTS, AND FACILITY WHERE RESEARCH WILL BE UNDERTAKEN The pediatric intensive care unit at the Alberta Children's Hospital 2.6 SAMPLE SIZE A total sample size of 112 participants (56 per arm)

Вмешательства

• Другое Therapeutic cuddling
  In bed or out of bed cuddling provided by a caregiver that involves at least two points of body contact with at least one providing pressure (e.g. arm over the torso or child in lap of parent)
• Другое Standard of care
  Cuddling or not as decided by the care team.

Первичные конечные точки

• Feasibility of randomization [Срок оценки: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]
• Feasibility of consent [Срок оценки: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]
• Ability to retain participants [Срок оценки: From PICU admission to end of enrollment period (96 hours) or PICU discharge whichever occurs first]

Вторичные конечные точки (5)

• Prevalence of the therapeutic cuddling intervention in those randomized to the standard of care arm [Срок оценки: From enrollment up to 14 study days or PICU discharge, whichever occurs first.]
• Feasibility of measurement of key outcomes and co-variates (i.e., pain, agitation, sedation, delirium, analgosedation exposure, parental presence) [Срок оценки: From enrollment up to 14 study days or PICU discharge whichever occurs first]
• Describe the experience of patients in receiving the therapeutic cuddling intervention [Срок оценки: Until the end of the study period, expected to complete within 18 months.]
• Describe the experiences of parents with therapeutic cuddling [Срок оценки: Until the end of the study period, expected to completed within 18 months.]
• Experience of HCP with delivering Therapeutic Cuddling [Срок оценки: Until study completion, an average of 18 months]

Критерии участия

Критерии включения

\- expected duration of admission of > 48 hours.

Критерии исключения

• Previously enrolled

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

Лечение

Центры проведения

Канада · 1 центр

• Alberta Children's Hospital — Calgary

Идентификаторы

NCT: NCT07562048 · REB25-0180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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