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

Study Overview
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Brief Summary
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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
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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) and oxygen saturation (O2) measurements are used to assess the child's anxiety, fear and pain. The data will be analysed using statistical methods.

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

Conditions
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Anxiety, Fear, Pain, Satisfaction

Intervention / Treatment
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* Other: Multisensoral Nature-based Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Children and parents receive a multisensoral nature-based intervention during venous blood sampling. | Other: Multisensoral Nature-based Intervention<br>* The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.<br>|
| No Intervention: Control Group<br>The control group receives the usual standard care during venous blood sampling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video. | The mYPAS (modifield Yale preoperative anxiety scale) was developed for external observers to assess a child's anxiety before and after a procedure and is suitable for measuring anxiety in children aged 2-16 years. The Modifield Yale preoperative scale measures the child's activity, voice, emotional expression and parental need (1-4/4, 1-6/6, 1-4/4, 1-4/4 points). Each item is scored separately and the total score is multiplied by 20. The lowest score for child anxiety is 1 and the highest score is 100. The scale has been tested for validity and relational validity (Kain X.N. et al. 1997). | Pre-intervention. Through study completion, an average of 1 year | 
| Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video. | The mYPAS (modifield Yale preoperative anxiety scale) was developed for external observers to assess a child's anxiety before and after a procedure and is suitable for measuring anxiety in children aged 2-16 years. The Modifield Yale preoperative scale measures the child's activity, voice, emotional expression and parental need (1-4/4, 1-6/6, 1-4/4, 1-4/4 points). Each item is scored separately and the total score is multiplied by 20. The lowest score for child anxiety is 1 and the highest score is 100. The scale has been tested for validity and relational validity (Kain X.N. et al. 1997). | After intervention. Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear. | The Children Fear Scale (CFS) is a modified version of the anxiety scale (McKinley et al. 2004). The five-item, gender-neutral, visual face scale measures fear in children aged 5-10 years and can be used pre- and post-procedure. Images are viewed from left to right, from non-fearful faces to very fearful faces (0-4 points). On the Children Fear Scale, unafraid faces score 0 points and very fearful faces score 4 points. The validity and relative validity of the scale have been tested (McMurtry et al. 2011). | Pre-intervention | 
| Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear. | The Children Fear Scale (CFS) is a modified version of the anxiety scale (McKinley et al. 2004). The five-item, gender-neutral, visual face scale measures fear in children aged 5-10 years and can be used pre- and post-procedure. Images are viewed from left to right, from non-fearful faces to very fearful faces (0-4 points). On the Children Fear Scale, unafraid faces score 0 points and very fearful faces score 4 points. The validity and relative validity of the scale have been tested (McMurtry et al. 2011). | Immediately after intervention | 
| Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain after blood sampling. | The Facial Affective Scale (FAS) (McGrath et al. 1996) measures the intensity of pain in children over 5 years of age and can be used after surgery. The Facial Affective Scale assesses a child's pain using nine facial images, presented in order from the happiest face (0.04 points) to the saddest face (0.97 points). A happy face (0.04 points) indicates no pain and a sad face (0.97 points) indicates very painful. The FAS score assesses the child's emotional or affective response to the experience of pain (Nguyen et al. 2010). The scale has been tested for validity and relative validity (Nilsson et al. 2014). | Immediately after intervention | 
| Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety. | The State-Trait Anxiety Inventory (STAI-Y1) measures an adult's anxiety, tension, fear and worry at the moment. The State-Trait Anxiety Inventory is a 4-point Likert scale (not at all anxious, number 1, somewhat anxious, number 2, moderately anxious, number 3, and very anxious, number 4) with 20 different questions. The State-Trait Anxiety Inventory STAI-Y1 measures situational anxiety (Copyright © 1983 by Charles D. Spielberger), in which the parent selects the number that best describes their own feelings at the moment. This study measures parent anxiety before and after the intervention. The scale has been tested for validity and relational validity (Nilsson et al. 2014). | Pre-intervention | 
| Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety. | The State-Trait Anxiety Inventory (STAI-Y1) measures an adult's anxiety, tension, fear and worry at the moment. The State-Trait Anxiety Inventory is a 4-point Likert scale (not at all anxious, number 1, somewhat anxious, number 2, moderately anxious, number 3, and very anxious, number 4) with 20 different questions. The State-Trait Anxiety Inventory STAI-Y1 measures situational anxiety (Copyright © 1983 by Charles D. Spielberger), in which the parent selects the number that best describes their own feelings at the moment. This study measures parent anxiety before and after the intervention. The scale has been tested for validity and relational validity (Nilsson et al. 2014). | Immediately after intervention | 
| Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling. | The VAS (A Visual Analogue Scale) assesses parent satisfaction on a scale of 0-10 after a blood sampling, where 0 means not at all satisfied and 10 means very satisfied.The scale has been tested for validity and relational validity (Abu-Saad 1984). | Immediately after intervention | 
| Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values. | The investigator measures the child's heart rate (HR) before the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next. | Pre-intervention | 
| Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values. | The investigator measures the child's heart rate (HR) after the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next. | Immediately after intervention | 
| Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values. | The principal investigator measures the oxygen saturation (O2) before the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next. | Pre-intervention | 
| Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values. | The principal investigator measures the oxygen saturation (O2) after the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next. | Immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Nature-based Intervention, Venipuncture