Clinical trial NCT05494684: Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling
Official title: Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Fear
Pain
Satisfaction
Keywords: Children
Nature-based Intervention
Venipuncture
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 53
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of the children participating in the study will be carried out using the Stratified Block Randomization-on method, which allows randomization in two groups, according to age, as follows: group 1 (5-6 years old) and group 2 (7-9 years old). This is to ensure that the intervention and control groups have the same number of children of the same age and do not differ in their starting level. The randomization lists are made by a statistician.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The child is aged between 5 and 9 years old
2. The child has a long-term illness (such as diabetes or rheumatism)
3. The child has previous experience of venous blood sampling
4. 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)
5. Child and parent understand and speak the Finnish language

Exclusion Criteria:

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

Primary outcomes:
measure: Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale). An external observer assesses the child's anxiety before blood sampling on video.
timeFrame: Before blood sampling
Secondary outcomes:
measure: Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling.
timeFrame: During blood sampling
measure: Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during blood sampling.
timeFrame: During blood sampling
measure: Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling.
timeFrame: Before blood sampling
measure: Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling.
timeFrame: After blood sampling
measure: Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute) during blood sampling.
timeFrame: During blood sampling
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu Univeristy
Study officials:
affiliation: Oulu University
name: Saija Huhtala
role: PRINCIPAL_INVESTIGATOR
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