Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety
- Sponsor
- University of Oulu
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale). An external observer assesses the child's anxiety before blood sampling on video.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Saija Huhtala
Principal Investigator
University of Oulu
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale). An external observer assesses the child's anxiety before blood sampling on video.
Time Frame: Before blood sampling
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).
Secondary Outcomes
- Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling.(During blood sampling)
- Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during blood sampling.(During blood sampling)
- Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling.(Before blood sampling)
- Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling.(After blood sampling)
- Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute) during blood sampling.(During blood sampling)