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

NCT05494684 | Not Yet Recruiting DMC

• 1 other identifier: 08072402
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fear; Pain; Satisfaction

Keywords

Children; Nature-based Intervention; Venipuncture

Outcome Measures

Primary Outcomes (1)

• 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).

  Before blood sampling

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Multisensoral Nature-based Intervention

Control Group

NO INTERVENTION

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

Interventions

Multisensoral Nature-based Intervention OTHER

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

Intervention Group

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu Univeristy

Oulu, Finland

Location

Related Publications (7)

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• McKinley S, Stein-Parbury J, Chehelnabi A, Lovas J. Assessment of anxiety in intensive care patients by using the Faces Anxiety Scale. Am J Crit Care. 2004 Mar;13(2):146-52.

  PMID: 15043242 BACKGROUND

• McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.

  PMID: 8783307 BACKGROUND

• Nguyen TN, Nilsson S, Hellstrom AL, Bengtson A. Music therapy to reduce pain and anxiety in children with cancer undergoing lumbar puncture: a randomized clinical trial. J Pediatr Oncol Nurs. 2010 May-Jun;27(3):146-55. doi: 10.1177/1043454209355983.

  PMID: 20386063 BACKGROUND

• Nilsson S, Finnstrom B, Morelius E, Forsner M. The facial affective scale as a predictor for pain unpleasantness when children undergo immunizations. Nurs Res Pract. 2014;2014:628198. doi: 10.1155/2014/628198. Epub 2014 Mar 5.

  PMID: 24734174 BACKGROUND

• Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. doi: 10.1016/0304-3959(84)90836-4.

  PMID: 6462728 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Saija Huhtala

  Oulu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huhtala

CONTACT

+358440807763; saijahuhtala76@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The children blood sampling will be videotaped. The principal investigator videos the blood sampling, and then external observer assesses the child's anxiety (mYPAS=Modifield Yale preoperative anxiety scale) on video. The video camera is pre-installed in the blood sampling room and positioned so that it does not attract attention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)