Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling

Официальное название

Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial

Обзор

This randomized controlled trial (RCT) study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The assessment uses different measures to assess child's anxiety, fear, pain and parent's anxiety and satisfaction during venous blood sampling.

Подробное описание

The RCT study aims to evaluate the effectiveness of multisensoral nature-based intervention compare to standard care in relieving anxiety, fear and pain in hospitalized child aged 5 to 9 years and parent's anxiety and satisfaction during venous blood sampling. The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment. The study will include children and parents in the intervention group (N=53, receiving the multisensoral nature-based intervention) and children and parents in the control group (N=53, receiving usual care). The children's blood sampling will be videotaped. The assessment uses different measures assess to child's anxiety (mYPAS = The modified Yale preoperative anxiety scale), child's fear (CFC = Children Fear Scale), child's pain (FAS = Facial Affective Scale), parent's anxiety (STAY-Y1 = The State-Trait Anxiety Inventory) and satisfaction (VAS = Visual Analogue Scale) during venous blood sampling. In addition, heart rate (HR) measurement are used to assess the child's anxiety, fear and pain. The data will be analysed using statistical methods.

Вмешательства

• Другое Multisensoral Nature-based Intervention
  The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.

Первичные конечные точки

• Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale). An external observer assesses the child's anxiety before blood sampling on video. [Срок оценки: Before blood sampling]

Вторичные конечные точки (5)

• Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling. [Срок оценки: During blood sampling]
• Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during blood sampling. [Срок оценки: During blood sampling]
• Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling. [Срок оценки: Before blood sampling]
• Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling. [Срок оценки: After blood sampling]
• Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute) during blood sampling. [Срок оценки: During blood sampling]

Критерии участия

Критерии включения

• The child is aged between 5 and 9 years old
• The child has a long-term illness (such as diabetes or rheumatism)
• The child has previous experience of venous blood sampling
• The child's level of development is age-appropriate (such as, the child is cared for at home or in day care/day nursery or attends school in the same level as the other children)
• Child and parent understand and speak the Finnish language

Критерии исключения

• The child has a diagnosis of abnormal neurological development (such as, a child has difficulty understanding spoken language or expressing emotions)
• The child has chronic pain that has lasted more than 3 months and requires strong painkillers (opiates).
• The child undergoes an examination or treatment during a check-up at the outpatient clinic that requires medical treatment similar to anesthesia
• The child is taking a sedative medication.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Финляндия · 1 центр

• Oulu Univeristy — Oulu

Публикации

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• Nilsson S, Finnstrom B, Morelius E, Forsner M. The facial affective scale as a predictor for pain unpleasantness when children undergo immunizations. Nurs Res Pract. 2014;2014:628198. doi: 10.1155/2014/628198. Epub 2014 Mar 5. PMID 24734174
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Идентификаторы

NCT: NCT05494684 · 08072402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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