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

NCT ID: NCT05494684

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

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.

Conditions

Anxiety; Fear; Pain; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Children and parents receive a multisensoral nature-based intervention during venous blood sampling.

Group Type: EXPERIMENTAL

Multisensoral Nature-based Intervention

Intervention Type: OTHER

The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.

Control Group

The control group receives the usual standard care during venous blood sampling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multisensoral Nature-based Intervention

The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Saija Huhtala

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saija Huhtala

Role: PRINCIPAL_INVESTIGATOR

Oulu University

Locations

Oulu Univeristy

Oulu, , Finland

Countries

Finland

Central Contacts

Huhtala

Role: CONTACT

saijahuhtala76@gmail.com

+358440807763

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

08072402

Identifier Type: -

Identifier Source: org_study_id