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

Official title

Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial

Overview

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.

Interventions

• Other Multisensoral Nature-based Intervention
  The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.

Primary outcome measures

• 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]

Secondary outcome measures (5)

• Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling. [Time frame: During blood sampling]
• Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during blood sampling. [Time frame: During blood sampling]
• Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling. [Time frame: Before blood sampling]
• Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling. [Time frame: After blood sampling]
• Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute) during blood sampling. [Time frame: During blood sampling]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Finland · 1 center

• Oulu Univeristy — Oulu

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05494684 · 08072402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗