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

U

University of Oulu

Status

Not yet enrolling

Conditions

Fear
Satisfaction
Anxiety
Pain

Treatments

Other: Multisensoral Nature-based Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05494684
08072402

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 estimated patients

Sex

All

Ages

5 to 9 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

53 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Children and parents receive a multisensoral nature-based intervention during venous blood sampling.
Treatment:
Other: Multisensoral Nature-based Intervention
Control Group
No Intervention group
Description:
The control group receives the usual standard care during venous blood sampling

Trial contacts and locations

1

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Central trial contact

Huhtala

Data sourced from clinicaltrials.gov

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