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

Sponsor
University of Oulu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05494684
Collaborator
(none)
53
1
2
21
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Multisensoral Nature-based Intervention
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Masking Description:
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 environment is masked and sounds are silenced on video (nature intervention includes nature sounds) so that the assessor does not know whether the child is in the intervention or control group, in order to reduce measurement bias. The video camera is pre-installed in the blood sampling room and positioned so that it does not attract attention.
Primary Purpose:
Treatment
Official Title:
Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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

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

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video. [Pre-intervention. Through study completion, an average of 1 year]

    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).

  2. Anxiety measured with mYPAS (the modifield Yale preoperative anxiety scale), change is being assessed. An external observer assesses the child's anxiety on video. [After intervention. Through study completion, an average of 1 year]

    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).

Secondary Outcome Measures

  1. Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear. [Pre-intervention]

    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).

  2. Fear measured with CFS (Children Fear Scale), change is being assessed. Child an parent assessment of fear. [Immediately after intervention]

    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).

  3. Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain after blood sampling. [Immediately after intervention]

    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).

  4. Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety. [Pre-intervention]

    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).

  5. Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory), change is being assessed. Parent self-assessment of own anxiety. [Immediately after intervention]

    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).

  6. Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling. [Immediately after intervention]

    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).

  7. Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values. [Pre-intervention]

    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.

  8. Child's anxiety, fear and pain with physiological measures: Heart Rate (HR, beats per minute), change is being assessed. Principal investigator measures values. [Immediately after intervention]

    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.

  9. Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values. [Pre-intervention]

    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.

  10. Child's anxiety, fear and pain with physiological measures: Oxygen saturation (02), change is being assessed. Principal investigator measures values. [Immediately after intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oulu Univeristy Oulu Finland

Sponsors and Collaborators

  • University of Oulu

Investigators

  • Principal Investigator: Saija Huhtala, Oulu University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Saija Huhtala, Principal Investigator, University of Oulu
ClinicalTrials.gov Identifier:
NCT05494684
Other Study ID Numbers:
  • 08072402
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saija Huhtala, Principal Investigator, University of Oulu

Study Results

No Results Posted as of Aug 15, 2022