AnxietyNCT05494684
Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling
A study testing Multisensoral Nature-based Intervention in people with Anxiety and Fear, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- What is being tested?
- Multisensoral Nature-based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University
Oulu
Tarja Pölkki, PhD, Professor, +358505794454, tarja.polkki@oulu.fi
About this study
Official title: Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial
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. The study also measures the time spent on blood sampling.
Read the 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 study also measures the time spent on blood sampling.The data will be analysed using statistical methods.
- Conditions
- Anxiety, Fear, Pain, Satifaction
- Being tested
- Multisensoral Nature-based Intervention
- Keywords
- Multisensory nature-based intervention, anxiety, fear, pain, blood sampling, RCT
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensoral Nature-based InterventionOther
The intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Children and parents receive a multisensoral nature-based intervention during venous blood sampling. Receives: Other: Multisensoral Nature-based Intervention |
| Control Group | No intervention | The control group receives the usual standard care during venous blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Anxiety is assessed immediately before the blood sampling procedure. The child's blood sampling procedure is video-recorded. An external assessor evaluates the child's anxiety based on the video recording.
Secondary outcomes (6)
Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling.
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 during blood sampling. 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).
Measured: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during 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 during blood sampling. 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).
Measured: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling.
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 blood sampling. The scale has been tested for validity and relational validity (Nilsson et al. 2014).
Measured: The parent's anxiety is assessed immediately before the child's blood sampling procedure.
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).
Measured: The parent's satisfaction is assessed immediately after the child's blood sampling procedure.
Child's anxiety, fear and pain with physiological measure: Heart Rate (HR, beats per minute) during blood sampling.
The child's heart rate (HR, beats per minute) is measured during blood sampling.
Measured: The child's heart rate is monitored during the blood sampling procedure, from baseline until the procedure is completed. A heart rate monitor is attached to the child's foot.
Time spent on blood sampling
The clock records the time taken to collect the blood sample.
Measured: The duration of the child's blood sampling procedure is measured from baseline until the end of the procedure. This information is obtained from the child's heart rate monitor and the video recording.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children aged 5-9 with chronic illnesses who are participating in the study will be randomized into intervention and control groups. The randomization list will be prepared by a statistician.
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saija Huhtala, University of Oulu
- Investigators
- Saija Huhtala, Principal investigator, Oulu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494684
- Sponsor's protocol ID
- 08072402
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9322455McMurtry 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.
PubMed 21806301McKinley 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.
PubMed 15043242McGrath 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.
PubMed 8783307Nguyen 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.
PubMed 20386063Nilsson 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.
PubMed 24734174Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. doi: 10.1016/0304-3959(84)90836-4.
PubMed 6462728
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children Aged 5 to 9 Years During Venous Blood Sampling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494684
- Acronym / sponsor ID
- 08072402
- Conditions
- Anxiety, Fear, Pain, Satifaction
- Keywords
- Multisensory nature-based intervention, anxiety, fear, pain, blood sampling, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The study also measures the time spent on 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 study also measures the time spent on blood sampling.The data will be analysed using statistical methods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Children aged 5-9 with chronic illnesses who are participating in the study will be randomized into intervention and control groups. The randomization list will be prepared by a statistician.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Multisensoral Nature-based InterventionChildren and parents receive a multisensoral nature-based intervention during venous blood sampling. |
| Control Group | No intervention | –The control group receives the usual standard care during venous blood sampling |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensoral Nature-based InterventionThe intervention includes a multi-sensory nature experience using natural materials and a virtually created natural environment. | Other | Intervention Group |
Primary outcome
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: Anxiety is assessed immediately before the blood sampling procedure. The child's blood sampling procedure is video-recorded. An external assessor evaluates the child's anxiety based on the video recording.
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).
6 secondary outcomes
Fear measured with CFS (Children Fear Scale). Child and parent assessment of fear during blood sampling.
Time frame: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Pain measured with FAS (Facial Affective Scale). Child and parent assessment of pain during blood sampling.
Time frame: The child's fear is assessed during blood sampling. The child and their parent are asked about the child's fear immediately after the blood sampling procedure.
Parent's anxiety with STAI-Y1 (The State-Trait Anxiety Inventory). Parent self-assessment of own anxiety before blood sampling.
Time frame: The parent's anxiety is assessed immediately before the child's blood sampling procedure.
Parent's satisfaction with VAS (A Visual Analogue Scale). Parent self-assessment of own satisfaction after blood sampling.
Time frame: The parent's satisfaction is assessed immediately after the child's blood sampling procedure.
Child's anxiety, fear and pain with physiological measure: Heart Rate (HR, beats per minute) during blood sampling.
Time frame: The child's heart rate is monitored during the blood sampling procedure, from baseline until the procedure is completed. A heart rate monitor is attached to the child's foot.
Time spent on blood sampling
Time frame: The duration of the child's blood sampling procedure is measured from baseline until the end of the procedure. This information is obtained from the child's heart rate monitor and the video recording.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 9322455Kain 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.
- Background: PubMed 21806301McMurtry 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.
- Background: PubMed 15043242McKinley 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.
- Background: PubMed 8783307McGrath 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.
- Background: PubMed 20386063Nguyen 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.
- Background: PubMed 24734174Nilsson 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.
- Background: PubMed 6462728Abu-Saad H. Assessing children's responses to pain. Pain. 1984 Jun;19(2):163-71. doi: 10.1016/0304-3959(84)90836-4.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saija Huhtala principal investigator
Oulu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensoral Nature-based Intervention in people with Anxiety and Fear, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saija Huhtala, MHSc, PhD candidate (+358440807763, saijahuhtala76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Anxiety is assessed immediately before the blood sampling procedure. The child's blood sampling procedure is video-recorded. An external assessor evaluates the child's anxiety based on the video recording.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494684, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.