An interventional study of Multisensoral Nature-based Intervention in Anxiety, Fear and Pain, sponsored by University of Oulu. Recruiting at 1 site in Finland. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Oulu · Not applicable, Interventional, and Supportive care
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. The study also measures the time spent on blood sampling.
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 study also measures the time spent on blood sampling.The data will be analysed using statistical methods.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 106 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Children and parents receive a multisensoral nature-based intervention during venous blood sampling.
Other: Multisensoral Nature-based Intervention
The control group receives the usual standard care during venous blood sampling
The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.
Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale). An external observer assesses the child's anxiety before blood sampling on video.
The mYPAS (modifield Yale preoperative anxiety scale) was developed for external observers to assess a child's anxiety before blood sampling 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).
Time frame: Anxiety is assessed immediately before the blood sampling procedure. The child's blood sampling procedure is video-recorded. An external assessor evaluates the child's anxiety based on the video recording.
Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling.
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 during blood sampling. 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).
Time frame: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during 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 during blood sampling. 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).
Time frame: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling.
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 blood sampling. The scale has been tested for validity and relational validity (Nilsson et al. 2014).
Time frame: The parent's anxiety is assessed immediately before the child's blood sampling procedure.
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).
Time frame: The parent's satisfaction is assessed immediately after the child's blood sampling procedure.
Child's anxiety, fear and pain with physiological measure: Heart Rate (HR, beats per minute) during blood sampling.
The child's heart rate (HR, beats per minute) is measured during blood sampling.
Time frame: The child's heart rate is monitored during the blood sampling procedure, from baseline until the procedure is completed. A heart rate monitor is attached to the child's foot.
Time spent on blood sampling
The clock records the time taken to collect the blood sample.
Time frame: The duration of the child's blood sampling procedure is measured from baseline until the end of the procedure. This information is obtained from the child's heart rate monitor and the video recording.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 18 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: start Aug 2025 → Dec 2026, primary completion Dec 2026 → Jun 2028 and completion Dec 2026 → Jun 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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