Procedural PainBREATHENCT07430514
Breathing Toy for Pain Relief in Pediatric Venipuncture
A study testing Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection in people with Procedural Pain and Acute Pain, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effectiveness of a realistic breathing toy distraction intervention on procedural pain, physiological parameters, and parental anxiety during venipuncture in children aged 1-3 years presenting to a pediatric emergency department. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Acute Pain, Pediatric Pain
- What is being tested?
- Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 31 May 2019
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian provided written informed consent
- Child aged 1-3 years
- No blood sampling within the previous 6 months
- Healthy children presenting for routine blood tests
- No analgesic medication within 4 hours prior to the procedure
- Child did not display fear of the breathing toy during initial introduction
- Child had intact sensory and neurological function
Who cannot join
- Chronic illness requiring regular blood sampling
- Known developmental delay or cognitive impairment
- Previous syncopal episode during blood collection
- Visual impairment
- Inability to obtain blood sample on first venipuncture attempt
- Current acute illness requiring hospitalization
Show all 9Show fewer
- Use of sedatives or anxiolytics within 24 hours prior to procedure
- Parents unable to provide informed consent in Turkish language
- Participation in another clinical trial within 30 days
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Children's Disease Training and Research Hospital
Istanbul, Istanbul, 34668
About this study
Official title: Effect of a Breathing Toy on Pain During Pediatric Venipuncture: A Randomized Controlled Trial
This randomized controlled trial evaluated the effectiveness of a realistic breathing toy distraction intervention on procedural pain, physiological parameters, and parental anxiety during venipuncture in children aged 1-3 years presenting to a pediatric emergency department.
Eighty children were randomly assigned to receive either a breathing toy distraction (experimental group, n=40) or standard care (control group, n=40) during blood collection. The breathing toy is a realistic plush dog that simulates breathing movements with its abdomen rising and falling while producing breathing sounds.
Read more
The primary outcome was pain intensity measured by the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale at 1 minute after the procedure. Secondary outcomes included heart rate, oxygen saturation, crying duration, and parental anxiety measured by the Beck Anxiety Inventory.
Results demonstrated significant reductions in pain scores (51% reduction), heart rate elevation, crying duration (72% reduction), and parental anxiety in the experimental group compared to the control group. No adverse events occurred. This simple, cost-effective intervention can be readily integrated into routine pediatric practice with minimal staff training.
Read the detailed description
BACKGROUND Young children frequently experience acute procedural pain during blood collection in emergency departments. Non-pharmacological interventions, including distraction techniques, are commonly used approaches for procedural pain management. However, evidence regarding the use of breathing simulation toys in toddlers during blood collection procedures is limited. This study aims to evaluate the effect of a breathing simulation toy on procedural pain and physiological parameters in toddlers undergoing blood sampling.
INTERVENTION The breathing toy (Perfect Petzzz brand) is a plush dog (23×9×17 cm) designed to simulate breathing movements through rhythmic abdominal rise and fall accompanied by breathing sounds. The toy complies with international toy safety standards (ASTM F963, CPSIA) and is made of hypoallergenic materials.
In the experimental group, the toy was introduced approximately 5 minutes before the blood collection procedure. The child was positioned on the parent's lap, with the toy placed on the child's lap. The child's hand was gently placed on the toy's abdomen to perceive the simulated breathing movements throughout the procedure. The researcher provided verbal guidance to help maintain the child's attention on the toy.
In the control group, children received standard care without a specific distraction intervention while positioned on the parent's lap. Parental comfort measures were allowed. Environmental conditions were kept consistent between groups.
METHODOLOGY All blood collections were performed by the same pediatric nurse using a 26-gauge butterfly needle from the antecubital vein. Two independent observers blinded to group allocation assessed pain using the FLACC scale. Physiological parameters were measured using a pulse oximeter at baseline (5 minutes before the procedure) and 1 minute after the procedure.
SAFETY For infection control, the toy's abdominal surface was covered with sterile disposable plastic film, which was replaced after each participant.
- Conditions
- Procedural Pain, Acute Pain, Pediatric Pain
- Being tested
- Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection
- Medical subject headings
- Pain, Procedural, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Simulation Plush Toy Distraction During Pediatric Blood CollectionBehavioural
A realistic plush breathing toy (Perfect Petzzz brand, 23×9×17 cm) that simulates the breathing pattern of a sleeping dog. The toy's abdomen rises and falls rhythmically while producing soft breathing sounds, creating a multi-sensory distraction experience (visual, tactile, auditory).
The toy was introduced to the child and parent approximately 5 minutes before venipuncture to allow familiarization. During the blood collection procedure, the child was positioned on the parent's lap with the toy placed on the child's lap. The researcher gently placed the child's hand on the toy's abdomen so the child could feel the simulated breathing movements. The researcher provided gentle verbal encouragement (e.g., "Feel the puppy breathing") to maintain the child's attention on the toy throughout the procedure.
The toy conforms to international toy safety standards
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Breathing Toy Distraction | Experimental | Children received a realistic breathing toy (Perfect Petzzz brand) during venipuncture. The toy was introduced 5 minutes before the procedure. The child was positioned on parent's lap with the toy on their lap. The child's hand was placed on the toy's abdomen to feel simulated breathing movements throughout the blood collection procedure. The researcher provided gentle verbal encouragement to maintain attention on the toy. Receives: Behavioral: Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection |
| No Intervention: Standard Care | No intervention | Children received standard care during venipuncture without specific distraction intervention. The child was positioned on parent's lap. Parental comfort measures (holding, talking to child) were permitted. Environmental conditions (lighting, noise, temperature) were maintained constant with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
FLACC Pain Scale: The Face, Legs, Activity, Cry, Consolability (FLACC) scale consists of five behavioral indicators, each scored 0-2 (total range 0-10), with higher scores indicating greater pain. The FLACC Scale consists of five behavioral categories, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. The Turkish version has established validity and reliability.
Measured: 1 minute post-procedure
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Pain intensity measured using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain assessment scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity. The scale consists of five behavioral indicators (face, legs, activity, cry, consolability), each scored 0-2 points. Two independent observers, blinded to group allocation, assessed FLACC scores.
Measured: 1 minute post-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 2026
- Study start1 Dec 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Eda Karadağ Aytemiz, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430514
- Sponsor's protocol ID
- KU-NURSING-2018-152
- Acronym
- BREATHE
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagnon MM, Hadjistavropoulos T, Williams J. Development and mixed-methods evaluation of a pain assessment video training program for long-term care staff. Pain Res Manag. 2013 Nov-Dec;18(6):307-12. doi: 10.1155/2013/659320. Epub 2013 Aug 16.
PubMed 23957021
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Breathing Toy on Pain During Pediatric Venipuncture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07430514
- Acronym / sponsor ID
- BREATHE / KU-NURSING-2018-152
- Conditions
- Procedural Pain, Acute Pain, Pediatric Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 24 Feb 2026 (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 evaluated the effectiveness of a realistic breathing toy distraction intervention on procedural pain, physiological parameters, and parental anxiety during venipuncture in children aged 1-3 years presenting to a pediatric emergency department.
Eighty children were randomly assigned to receive either a breathing toy distraction (experimental group, n=40) or standard care (control group, n=40) during blood collection. The breathing toy is a realistic plush dog that simulates breathing movements with its abdomen rising and falling while producing breathing sounds.
The primary outcome was pain intensity measured by the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale at 1 minute after the procedure. Secondary outcomes included heart rate, oxygen saturation, crying duration, and parental anxiety measured by the Beck Anxiety Inventory.
Results demonstrated significant reductions in pain scores (51% reduction), heart rate elevation, crying duration (72% reduction), and parental anxiety in the experimental group compared to the control group. No adverse events occurred. This simple, cost-effective intervention can be readily integrated into routine pediatric practice with minimal staff training.
Detailed description
BACKGROUND Young children frequently experience acute procedural pain during blood collection in emergency departments. Non-pharmacological interventions, including distraction techniques, are commonly used approaches for procedural pain management. However, evidence regarding the use of breathing simulation toys in toddlers during blood collection procedures is limited. This study aims to evaluate the effect of a breathing simulation toy on procedural pain and physiological parameters in toddlers undergoing blood sampling.
INTERVENTION The breathing toy (Perfect Petzzz brand) is a plush dog (23×9×17 cm) designed to simulate breathing movements through rhythmic abdominal rise and fall accompanied by breathing sounds. The toy complies with international toy safety standards (ASTM F963, CPSIA) and is made of hypoallergenic materials.
In the experimental group, the toy was introduced approximately 5 minutes before the blood collection procedure. The child was positioned on the parent's lap, with the toy placed on the child's lap. The child's hand was gently placed on the toy's abdomen to perceive the simulated breathing movements throughout the procedure. The researcher provided verbal guidance to help maintain the child's attention on the toy.
In the control group, children received standard care without a specific distraction intervention while positioned on the parent's lap. Parental comfort measures were allowed. Environmental conditions were kept consistent between groups.
METHODOLOGY All blood collections were performed by the same pediatric nurse using a 26-gauge butterfly needle from the antecubital vein. Two independent observers blinded to group allocation assessed pain using the FLACC scale. Physiological parameters were measured using a pulse oximeter at baseline (5 minutes before the procedure) and 1 minute after the procedure.
SAFETY For infection control, the toy's abdominal surface was covered with sterile disposable plastic film, which was replaced after each participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Breathing Toy Distraction | Experimental | Behavioral: Breathing Simulation Plush Toy Distraction During Pediatric Blood CollectionChildren received a realistic breathing toy (Perfect Petzzz brand) during venipuncture. The toy was introduced 5 minutes before the procedure. The child was positioned on parent's lap with the toy on their lap. The child's hand was placed on the toy's abdomen to feel simulated breathing movements throughout the blood collection procedure. The researcher provided gentle verbal encouragement to maintain attention on the toy. |
| No Intervention: Standard Care | No intervention | –Children received standard care during venipuncture without specific distraction intervention. The child was positioned on parent's lap. Parental comfort measures (holding, talking to child) were permitted. Environmental conditions (lighting, noise, temperature) were maintained constant with the experimental group. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parent or legal guardian provided written informed consent
- Child aged 1-3 years
- No blood sampling within the previous 6 months
- Healthy children presenting for routine blood tests
- No analgesic medication within 4 hours prior to the procedure
Key exclusion criteria (9 listed)
- Chronic illness requiring regular blood sampling
- Known developmental delay or cognitive impairment
- Previous syncopal episode during blood collection
- Visual impairment
- Inability to obtain blood sample on first venipuncture attempt
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 |
|---|---|---|
| Breathing Simulation Plush Toy Distraction During Pediatric Blood CollectionA realistic plush breathing toy (Perfect Petzzz brand, 23×9×17 cm) that simulates the breathing pattern of a sleeping dog. The toy's abdomen rises and falls rhythmically while producing soft breathing sounds, creating a multi-sensory distraction experience (visual, tactile, auditory). The toy was introduced to the child and parent approximately 5 minutes before venipuncture to allow familiarization. During the blood collection procedure, the child was positioned on the parent's lap with the toy placed on the child's lap. The researcher gently placed the child's hand on the toy's abdomen so the child could feel the simulated breathing movements. The researcher provided gentle verbal encouragement (e.g., "Feel the puppy breathing") to maintain the child's attention on the toy throughout the procedure. The toy conforms to international toy safety standards | Behavioural | Experimental: Breathing Toy Distraction |
Primary outcome
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time frame: 1 minute post-procedure
FLACC Pain Scale: The Face, Legs, Activity, Cry, Consolability (FLACC) scale consists of five behavioral indicators, each scored 0-2 (total range 0-10), with higher scores indicating greater pain. The FLACC Scale consists of five behavioral categories, each scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate greater pain intensity. The Turkish version has established validity and reliability.
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time frame: 1 minute post-procedure
Pain intensity measured using the Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain assessment scale. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity. The scale consists of five behavioral indicators (face, legs, activity, cry, consolability), each scored 0-2 points. Two independent observers, blinded to group allocation, assessed FLACC scores.
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 24 Feb 2026.
- Results publication: PubMed 23957021Gagnon MM, Hadjistavropoulos T, Williams J. Development and mixed-methods evaluation of a pain assessment video training program for long-term care staff. Pain Res Manag. 2013 Nov-Dec;18(6):307-12. doi: 10.1155/2013/659320. Epub 2013 Aug 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Simulation Plush Toy Distraction During Pediatric Blood Collection in people with Procedural Pain and Acute Pain, run by Koç University 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 9 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 24 Feb 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 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?
Pain Intensity During Blood Collection Assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (time frame: 1 minute post-procedure). The study lists 2 primary outcomes in all. 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 NCT07430514, which also lists 1 linked publication.
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 24 Feb 2026.