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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05494684
• Other study ID #: 08072402
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2022
• Source: University of Oulu
• Contact: Huhtala
• Phone: +358440807763
• Email: saijahuhtala76[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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) and oxygen saturation (O2) measurements are used to assess the child's anxiety, fear and pain. The data will be analysed using statistical methods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 53
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Fear
• Pain
• Satisfaction

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu Univeristy	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (7)

Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nguyen TN, Nilsson S, Hellström 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. — View Citation

Nilsson S, Finnström B, Mörelius 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video.	The mYPAS (modifield Yale preoperative anxiety scale) was developed for external observers to assess a child's anxiety before and after a procedure 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).	Pre-intervention. Through study completion, an average of 1 year
Primary	Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video.	The mYPAS (modifield Yale preoperative anxiety scale) was developed for external observers to assess a child's anxiety before and after a procedure 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).	After intervention. Through study completion, an average of 1 year
Secondary	Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear.	The Children Fear Scale (CFS) is a modified version of the anxiety scale (McKinley et al. 2004). The five-item, gender-neutral, visual face scale measures fear in children aged 5-10 years and can be used pre- and post-procedure. Images are viewed from left to right, from non-fearful faces to very fearful faces (0-4 points). On the Children Fear Scale, unafraid faces score 0 points and very fearful faces score 4 points. The validity and relative validity of the scale have been tested (McMurtry et al. 2011).	Pre-intervention
Secondary	Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear.	The Children Fear Scale (CFS) is a modified version of the anxiety scale (McKinley et al. 2004). The five-item, gender-neutral, visual face scale measures fear in children aged 5-10 years and can be used pre- and post-procedure. Images are viewed from left to right, from non-fearful faces to very fearful faces (0-4 points). On the Children Fear Scale, unafraid faces score 0 points and very fearful faces score 4 points. The validity and relative validity of the scale have been tested (McMurtry et al. 2011).	Immediately after intervention
Secondary	Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain after blood sampling.	The Facial Affective Scale (FAS) (McGrath et al. 1996) measures the intensity of pain in children over 5 years of age and can be used after surgery. The Facial Affective Scale assesses a child's pain using nine facial images, presented in order from the happiest face (0.04 points) to the saddest face (0.97 points). A happy face (0.04 points) indicates no pain and a sad face (0.97 points) indicates very painful. The FAS score assesses the child's emotional or affective response to the experience of pain (Nguyen et al. 2010). The scale has been tested for validity and relative validity (Nilsson et al. 2014).	Immediately after intervention
Secondary	Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety.	The State-Trait Anxiety Inventory (STAI-Y1) measures an adult's anxiety, tension, fear and worry at the moment. The State-Trait Anxiety Inventory is a 4-point Likert scale (not at all anxious, number 1, somewhat anxious, number 2, moderately anxious, number 3, and very anxious, number 4) with 20 different questions. The State-Trait Anxiety Inventory STAI-Y1 measures situational anxiety (Copyright © 1983 by Charles D. Spielberger), in which the parent selects the number that best describes their own feelings at the moment. This study measures parent anxiety before and after the intervention. The scale has been tested for validity and relational validity (Nilsson et al. 2014).	Pre-intervention
Secondary	Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety.	The State-Trait Anxiety Inventory (STAI-Y1) measures an adult's anxiety, tension, fear and worry at the moment. The State-Trait Anxiety Inventory is a 4-point Likert scale (not at all anxious, number 1, somewhat anxious, number 2, moderately anxious, number 3, and very anxious, number 4) with 20 different questions. The State-Trait Anxiety Inventory STAI-Y1 measures situational anxiety (Copyright © 1983 by Charles D. Spielberger), in which the parent selects the number that best describes their own feelings at the moment. This study measures parent anxiety before and after the intervention. The scale has been tested for validity and relational validity (Nilsson et al. 2014).	Immediately after intervention
Secondary	Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling.	The VAS (A Visual Analogue Scale) assesses parent satisfaction on a scale of 0-10 after a blood sampling, where 0 means not at all satisfied and 10 means very satisfied.The scale has been tested for validity and relational validity (Abu-Saad 1984).	Immediately after intervention
Secondary	Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values.	The investigator measures the child's heart rate (HR) before the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next.	Pre-intervention
Secondary	Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values.	The investigator measures the child's heart rate (HR) after the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next.	Immediately after intervention
Secondary	Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values.	The principal investigator measures the oxygen saturation (O2) before the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next.	Pre-intervention
Secondary	Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values.	The principal investigator measures the oxygen saturation (O2) after the blood sampling. A small measuring device is placed on the child's fingertip, which does not cause physical pain and is only on the child's fingertip for a short time (about 1min.) The investigator stands next to the child and parent and proactively tells the child about the measuring device and what happens next.	Immediately after intervention