Pain ManagementPIPSNCT06841289
The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use in Blood Collection Procedure
A study testing Pediatric Invasive Pictorial Shield (PIPS) and Distraction cards in people with Pain Management and Fear Anxiety, run by Dilek Kucuk Alemdar at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Pain Management, Fear Anxiety, Child
- What is being tested?
- Pediatric Invasive Pictorial Shield (PIPS) and Distraction cards
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child must be between 6-10 years old, and the child and parents must agree to participate in the study
- Blood collection is done by the same nurse
- Standard information is given to the child and family before blood collection - - The blood collection method to be used for the procedure (butterfly set
- Children should have the perception level to evaluate the pain/fear/anxiety scale (successfully complete the scale tests)
- The child does not have any auditory, mental or neurological disability that may affect the child's participation in the research
- The child has no hearing, speech or visual impairment Blood collection from the antecubital region
- Single attempt intervention.
Who cannot join
- The child has any special needs (physical, sensory or mental)
- The child is admitted to the hospital with a complaint of acute pain
- Body temperature outside the range of 36.5-37.2°C153
- Having a disease that can cause chronic pain The child has taken analgesics in the last 6 hours
- The child has a health problem that may affect the level of pain (tissue trauma, burn, fracture, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use on Pain, Fear and Anxiety in Blood Collection Procedure
This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
Read the detailed description
Invasive procedures are the most common and important sources of pain, anxiety, stress and fear for children. Painful procedures also cause reluctance to medical procedures and distrust of nurses in both children and parents. Pain, anxiety and fear from needle procedures in childhood can persist into adulthood. It may cause negative emotional effects in the long term. Therefore, it is very important to reduce or eliminate pain during stressful and uncomfortable procedures in children. Nurses should also provide atraumatic care to children by minimizing pain. Eliminating pain and improving the quality of life of children should be one of the main goals of nursing care. The methods used in pain control in children are pharmacologic and nonpharmacologic methods. One of the non-pharmacologic methods, the technique of distraction, is the concentration of attention on a stimulus other than pain. Unlike what we have previously encountered in the literature, the Pediatric Invasive Pictorial Shield (PIPS) also aims to minimize the impact of the intervention by preventing the child from seeing the procedure being performed. Distraction cards are also known to be an effective method in children. This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
- Conditions
- Pain Management, Fear Anxiety, Child
- Being tested
- Pediatric Invasive Pictorial Shield (PIPS), Distraction cards
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Invasive Pictorial Shield (PIPS)Combination product
It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side. The device is fixed on the child's arm by means of a tourniquet that can be interchangeably attached. The child asked questions about the pictures related to the stickers to distract his/her attention from the procedure. While answering these questions, the child will not see the procedures and will pay attention to the pictures, while the procedural procedure (such as blood sampling, intravenous intervention) will be performed. For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure.
Distraction cardsBehavioural
Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Invasive Pictorial Shield (PIPS) | Experimental | It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side. Receives: Combination Product: Pediatric Invasive Pictorial Shield (PIPS) |
| Distraction cards | Other | Distraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used . For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure. Receives: Behavioral: Distraction cards |
| Control | No intervention | No distraction method will be applied to the children in the control group before the blood collection procedure. After explaining the procedure according to the developmental level of the child, blood collection will be performed by the same nurse in accordance with the institutional policy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oucher Scale
Oucher is a poster-like tool designed to help children self-report the intensity of their pain. The Oucher consists of two scales: a numerical scale from 0-10 for older children and a photographic scale with six pictures for younger children. The Oucher can be used to assess pain intensity whenever the child is awake and conscious. Oucher can be used in children aged 3-12 years.
Measured: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Child Anxiety Scale-Dispositional (CAS-D)
The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children instructed to "Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer". "If you are a little worried or nervous, the emotions might go up a little on the thermometer. If you are very, very anxious or nervous, emotions all the way to the top. Put a line on the thermometer showing how anxious or nervous you are". To measure state anxiety (CAS-D), the child is asked to mark how they feel "right now". The score can vary between 0 and 10
Measured: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Child Fear Scale (CFS)
This scale is used to determine the child's level of fear. The child fear scale is a visual scale consisting of five facial expressions characterized as no reaction (0=no anxiety) and scared face (4=severe anxiety) and can be scored from 0 to 4. It is intended for children aged 5-10 years (Gerçeker et al., 2018)
Measured: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Venham Pictorial Anxiety Scale (VRAQ)
It was developed as a situational anxiety scale for children. It measures anxiety appropriate for children in stressful situations. The scale was developed by Venham et al. in 1979. The scale is used for children over 3 years of age. The scale consists of eight sections and each section two pictures. The pictures in each section are shown to the child in order. The picture with anxiety is given 1 point and the picture without anxiety is 0 point. The lowest score is 0 and the highest score is 8 points. In the scoring system from 0 to 8, as the number of points increases, the rate of anxiety increases
Measured: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Secondary outcomes (1)
Nurse-Patient Collaboration and Parental Satisfaction Form (NPPC-EMF)
Nurse-Patient Cooperation Level and Parental Satisfaction Form was developed by Aydemir in 2020. "Nurse-Patient Cooperationsection consists of two questions directed to the nurse who performed the procedure. The scope of the questioning includes rating how the patient's compliance is during the application process and whether the continuity of the application is desired. The patient is asked to rate the patient's compliance with the procedure between zero and 10 points. Zero is the worst and 10 the best compliance. The status of wanting the application again was graded with the responses of I would like, I am undecided and I do not want. In the "Satisfaction of the Patient's Parent" section, there are two questions directed to the parents regarding the satisfaction and continuity of the application. Parental satisfaction was scaled on a five-point Likert scale one to five, with one being the most dissatisfied
Measured: 5 minute after the blood collection procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start17 Feb 2025
- Primary completion15 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- The study was a randomized controlled experimental, prospective study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek Kucuk Alemdar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dilek Kucuk Alemdar, Ordu University
- Investigators
- Dilek Küçük Alemdar, Professor, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841289
- Sponsor's protocol ID
- KAEK360
- Acronym
- PIPS
- Status last verified
- Jun 2025
- First submitted
- 18 Feb 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pediatric Invasive Pictorial Shield (PIPS) and Distraction Card Use on Pain, Fear and Anxiety in Blood Collection Procedure
- ClinicalTrials.gov ID
- NCT06841289
- Acronym / sponsor ID
- PIPS / KAEK360
- Conditions
- Pain Management, Fear Anxiety, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dilek Kucuk AlemdarUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 24 Feb 2025 (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 study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
Detailed description
Invasive procedures are the most common and important sources of pain, anxiety, stress and fear for children. Painful procedures also cause reluctance to medical procedures and distrust of nurses in both children and parents. Pain, anxiety and fear from needle procedures in childhood can persist into adulthood. It may cause negative emotional effects in the long term. Therefore, it is very important to reduce or eliminate pain during stressful and uncomfortable procedures in children. Nurses should also provide atraumatic care to children by minimizing pain. Eliminating pain and improving the quality of life of children should be one of the main goals of nursing care. The methods used in pain control in children are pharmacologic and nonpharmacologic methods. One of the non-pharmacologic methods, the technique of distraction, is the concentration of attention on a stimulus other than pain. Unlike what we have previously encountered in the literature, the Pediatric Invasive Pictorial Shield (PIPS) also aims to minimize the impact of the intervention by preventing the child from seeing the procedure being performed. Distraction cards are also known to be an effective method in children. This study was planned as a randomized controlled experimental study to minimize the pain, anxiety and fear of the child during venous blood sampling in order to avoid a painful experience in the future. The research will be conducted in the Pediatric Blood Collection Unit of Giresun Gynecology and Obstetrics Training and Research Hospital in children aged 6-10 years. The research data will be collected using the "Information Form on Descriptive Characteristics of the Child and Blood Collection Procedure, Child Anxiety Scale-Disposition (CAS-D), Oucher Scale, Child Fear Scale (CFS), Venham Pictorial Anxiety Scale (VRAAS)" and Nurse-Patient Cooperation and Parent Satisfaction Form (NPPS-EMF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was a randomized controlled experimental, prospective study.
| Arm | Type | Receives |
|---|---|---|
| Pediatric Invasive Pictorial Shield (PIPS) | Experimental | Combination Product: Pediatric Invasive Pictorial Shield (PIPS)It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side. |
| Distraction cards | Other | Behavioral: Distraction cardsDistraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used . For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure. |
| Control | No intervention | –No distraction method will be applied to the children in the control group before the blood collection procedure. After explaining the procedure according to the developmental level of the child, blood collection will be performed by the same nurse in accordance with the institutional policy. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The child must be between 6-10 years old, and the child and parents must agree to participate in the study
- Blood collection is done by the same nurse
- Standard information is given to the child and family before blood collection - - The blood collection method to be used for the procedure (butterfly set
- Children should have the perception level to evaluate the pain/fear/anxiety scale (successfully complete the scale tests)
- The child does not have any auditory, mental or neurological disability that may affect the child's participation in the research
Key exclusion criteria (5 listed)
- The child has any special needs (physical, sensory or mental)
- The child is admitted to the hospital with a complaint of acute pain
- Body temperature outside the range of 36.5-37.2°C153
- Having a disease that can cause chronic pain The child has taken analgesics in the last 6 hours
- The child has a health problem that may affect the level of pain (tissue trauma, burn, fracture, etc.).
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 |
|---|---|---|
| Pediatric Invasive Pictorial Shield (PIPS)It is a device used to distract children during clinical procedures (blood sampling, invasive procedures, etc.) by making them feel less pain, stress and fear. It is an 18x15 cm 3D printed device designed to be worn around the upper arm, above the elbow, and used to hide the procedure from view and attract the child's attention with stickers printed on one side. The device is fixed on the child's arm by means of a tourniquet that can be interchangeably attached. The child asked questions about the pictures related to the stickers to distract his/her attention from the procedure. While answering these questions, the child will not see the procedures and will pay attention to the pictures, while the procedural procedure (such as blood sampling, intravenous intervention) will be performed. For the children in this group, the pain, fear will be scored 1 minute before, during and 1 minute after the blood collection procedure. | Combination product | Pediatric Invasive Pictorial Shield (PIPS) |
| Distraction cardsDistraction cards consist of picture cards with various hidden pictures and patterns. These hidden pictures and patterns can only seen by the child if he/she looks carefully. During the procedure, the child is expected to focus on the cards and answerabout the pictures and shapes on the cards. In this study, 5X8 cm cards with various pictures and shapes will be used. | Behavioural | Distraction cards |
Primary outcome
Oucher Scale
Time frame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
Oucher is a poster-like tool designed to help children self-report the intensity of their pain. The Oucher consists of two scales: a numerical scale from 0-10 for older children and a photographic scale with six pictures for younger children. The Oucher can be used to assess pain intensity whenever the child is awake and conscious. Oucher can be used in children aged 3-12 years.
Child Anxiety Scale-Dispositional (CAS-D)
Time frame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
The CAS-D is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. In this scale for children aged four to ten, children instructed to "Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer". "If you are a little worried or nervous, the emotions might go up a little on the thermometer. If you are very, very anxious or nervous, emotions all the way to the top. Put a line on the thermometer showing how anxious or nervous you are". To measure state anxiety (CAS-D), the child is asked to mark how they feel "right now". The score can vary between 0 and 10
Child Fear Scale (CFS)
Time frame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
This scale is used to determine the child's level of fear. The child fear scale is a visual scale consisting of five facial expressions characterized as no reaction (0=no anxiety) and scared face (4=severe anxiety) and can be scored from 0 to 4. It is intended for children aged 5-10 years (Gerçeker et al., 2018)
Venham Pictorial Anxiety Scale (VRAQ)
Time frame: 1 minute before, during procedure and 1 minute after the blood collection procedure.
It was developed as a situational anxiety scale for children. It measures anxiety appropriate for children in stressful situations. The scale was developed by Venham et al. in 1979. The scale is used for children over 3 years of age. The scale consists of eight sections and each section two pictures. The pictures in each section are shown to the child in order. The picture with anxiety is given 1 point and the picture without anxiety is 0 point. The lowest score is 0 and the highest score is 8 points. In the scoring system from 0 to 8, as the number of points increases, the rate of anxiety increases
1 secondary outcome
Nurse-Patient Collaboration and Parental Satisfaction Form (NPPC-EMF)
Time frame: 5 minute after the blood collection procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dilek Küçük Alemdar, Professor study director
Ordu 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 Pediatric Invasive Pictorial Shield (PIPS) and Distraction cards in people with Pain Management and Fear Anxiety, run by Dilek Kucuk Alemdar at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oucher Scale (time frame: 1 minute before, during procedure and 1 minute after the blood collection procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2025.