Nursing CareNCT07249723
Comparison of the Effectiveness of Two Active Distraction Techniques During Venipuncture in Children
A study testing Bubble Blowing Group and Positive Reinforcement Group in people with Nursing Care and Pain Management, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to compare the effects of two active distraction methods-bubble blowing and a material-free cognitive distraction/positive reinforcement technique-applied during venous blood sampling on pain, fear, and anxiety levels in children aged 7-12 years. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Care, Pain Management, Anxiety
- What is being tested?
- Bubble Blowing Group and Positive Reinforcement Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Jul 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 7 and 12 years,
- Literate (able to read and write),
- Having no diagnosed visual, hearing, intellectual, or neurological disorder,
- With no history of analgesic, sedative, or narcotic use within 24 hours prior to admission,
- Children who, together with their parent, volunteered to participate.
Who cannot join
- Children who do not meet the inclusion criteria,
- Children or parents who wish to withdraw from the study at any stage,
- Children from whom a blood sample could not be obtained with a single venipuncture attempt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Active Distraction Methods in Reducing Pain, Fear, and Anxiety in Children Undergoing Venous Blood Sampling
This study was conducted to compare the effects of two active distraction methods-bubble blowing and a material-free cognitive distraction/positive reinforcement technique-applied during venous blood sampling on pain, fear, and anxiety levels in children aged 7-12 years.
Read the detailed description
Distraction is an effective non-pharmacological nursing intervention used to reduce pain, fear, and anxiety in children during invasive procedures. This approach aims to decrease the child's emotional distress by diverting attention away from the perceived threat.
In particular, among children aged 7-12 years, procedure-related fear and avoidance behaviors may increase due to the impact of previous medical experiences; therefore, there is a need for comparative evaluation of effective distraction strategies tailored to this age group. While sensory-kinesthetic methods such as bubble blowing promote active participation, material-free cognitive techniques can be implemented in any setting and offer easily accessible options. However, studies directly comparing these methods remain limited.
- Conditions
- Nursing Care, Pain Management, Anxiety, Children
- Being tested
- Bubble Blowing Group, Positive Reinforcement Group
- Keywords
- Acute pain; Distraction; Bubble blowing; Positive reinforcement, Acute pain, Distraction, Bubble blowing, Positive reinforcement
- Medical subject headings
- Agnosia, Anxiety Disorders, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble Blowing GroupOther
In the Bubble Blowing Group, children were given a bubble toy during the procedure and asked to blow bubbles. This method, which requires active motor participation, was used to divert the children's attention away from the stress of the procedure.
Positive Reinforcement GroupOther
In the Positive Reinforcement Group, children performed a non-material cognitive activity of their choice during the procedure (such as counting, reciting a short poem/song, or a word game). At the end of the procedure, verbal positive reinforcement was provided (e.g., "Well done," "You were very brave").
| Study group | Role | What they receive |
|---|---|---|
| Bubble Blowing Group | Experimental | Before the procedure, each child was given a bubble toy and instructed to blow bubbles throughout the procedure. The procedure duration was recorded with a stopwatch. Post-procedural pain and anxiety were assessed using standardized scales. A single-use bubble toy was used for each child. Receives: Other: Bubble Blowing Group |
| Positive Reinforcement Group | Experimental | Before the procedure, the researcher established communication with the child, and a short cognitive activity chosen by the child (e.g., counting numbers, word game) was implemented throughout the procedure. The parent provided physical and verbal support to the child. After the procedure, the child received verbal positive reinforcement. Receives: Other: Positive Reinforcement Group |
| Standard Procedure Blood Sampling Group | No intervention | Children in the control group underwent the standard blood sampling procedure in accordance with routine clinical practice. Outcome measurements were conducted after the procedure. Once data collection was completed, children in this group also received verbal feedback. All measurements were performed immediately before and after venipuncture. A single-needle insertion technique was used, and all blood draws were performed by the same pediatric nurse, who was permanently assigned to the unit, to ensure procedural standardization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Developed by Wong and Baker (1988), this scale assesses pain intensity in children aged 3-18 years based on facial expressions, using a 0-5 scoring system. Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale (0-10; higher scores indicate worse pain).
Measured: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
Children's Fear and Anxiety Scale (CFS)
Developed by McMurtry et al. (2011) and adapted into Turkish by Gerçeker et al. (2018), this scale evaluates fear and anxiety during the procedure on a 0-4 rating scale. 0-10; higher scores indicate greater fear and anxiety.
Measured: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
Secondary outcomes (1)
Visual Analog Scale (VAS)
The VAS is a valid and reliable scale that measures pain intensity on a 0-10 cm linear line (Wewers \& Lowe, 1990). All scales were administered before and after the procedure.
Measured: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Nursing CareStudies 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Yalnızoglu Caka, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249723
- Sponsor's protocol ID
- 18.11.2025
- Other IDs
- 2209
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Czech O, Wrzeciono A, Rutkowska A, Guzik A, Kiper P, Rutkowski S. Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 23;10(15):3248. doi: 10.3390/jcm10153248.
PubMed 34362032Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
PubMed 2197679Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.
PubMed 36737707McMurtry 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 21806301Lawson SL, Hogg MM, Moore CG, Anderson WE, Osipoff PS, Runyon MS, Reynolds SL. Pediatric Pain Assessment in the Emergency Department: Patient and Caregiver Agreement Using the Wong-Baker FACES and the Faces Pain Scale-Revised. Pediatr Emerg Care. 2021 Dec 1;37(12):e950-e954. doi: 10.1097/PEC.0000000000001837.
PubMed 31335787Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
PubMed 30362982Gerçeker, G.Ö., Ayar, D., Özdemir, E. Z., & Bektaş, M. (2018). Gaining of Children's state anxiety and Children's fear scale to Turkish language. E- Journal of Dokuz Eylul University Nursing Faculty, 11(1), 9-13. https://dergipark.org.tr/tr/pub/deuhfed/issue/46786/586670
Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.
PubMed 33485746Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
PubMed 35068011Caka SY, Cebeci E, Kavi HO, Balikci N, Topal S. Comparison of the effectiveness of two active distraction methods in reducing pain, fear, and anxiety in children during venipuncture: a randomized controlled trial. BMC Pediatr. 2026 Jul 7. doi: 10.1186/s12887-026-07249-9. Online ahead of print.
PubMed 42414960
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Active Distraction Methods in Reducing Pain, Fear, and Anxiety in Children Undergoing Venous Blood Sampling
- ClinicalTrials.gov ID
- NCT07249723
- Acronym / sponsor ID
- 18.11.2025
- Conditions
- Nursing Care, Pain Management, Anxiety, Children
- Keywords
- Acute pain; Distraction; Bubble blowing; Positive reinforcement, Acute pain, Distraction, Bubble blowing, Positive reinforcement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 25 Nov 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 conducted to compare the effects of two active distraction methods-bubble blowing and a material-free cognitive distraction/positive reinforcement technique-applied during venous blood sampling on pain, fear, and anxiety levels in children aged 7-12 years.
Detailed description
Distraction is an effective non-pharmacological nursing intervention used to reduce pain, fear, and anxiety in children during invasive procedures. This approach aims to decrease the child's emotional distress by diverting attention away from the perceived threat.
In particular, among children aged 7-12 years, procedure-related fear and avoidance behaviors may increase due to the impact of previous medical experiences; therefore, there is a need for comparative evaluation of effective distraction strategies tailored to this age group. While sensory-kinesthetic methods such as bubble blowing promote active participation, material-free cognitive techniques can be implemented in any setting and offer easily accessible options. However, studies directly comparing these methods remain limited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bubble Blowing Group | Experimental | Other: Bubble Blowing GroupBefore the procedure, each child was given a bubble toy and instructed to blow bubbles throughout the procedure. The procedure duration was recorded with a stopwatch. Post-procedural pain and anxiety were assessed using standardized scales. A single-use bubble toy was used for each child. |
| Positive Reinforcement Group | Experimental | Other: Positive Reinforcement GroupBefore the procedure, the researcher established communication with the child, and a short cognitive activity chosen by the child (e.g., counting numbers, word game) was implemented throughout the procedure. The parent provided physical and verbal support to the child. After the procedure, the child received verbal positive reinforcement. |
| Standard Procedure Blood Sampling Group | No intervention | –Children in the control group underwent the standard blood sampling procedure in accordance with routine clinical practice. Outcome measurements were conducted after the procedure. Once data collection was completed, children in this group also received verbal feedback. All measurements were performed immediately before and after venipuncture. A single-needle insertion technique was used, and all blood draws were performed by the same pediatric nurse, who was permanently assigned to the unit, to ensure procedural standardization. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged between 7 and 12 years,
- Literate (able to read and write),
- Having no diagnosed visual, hearing, intellectual, or neurological disorder,
- With no history of analgesic, sedative, or narcotic use within 24 hours prior to admission,
- Children who, together with their parent, volunteered to participate.
Key exclusion criteria (3 listed)
- Children who do not meet the inclusion criteria,
- Children or parents who wish to withdraw from the study at any stage,
- Children from whom a blood sample could not be obtained with a single 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 |
|---|---|---|
| Bubble Blowing GroupIn the Bubble Blowing Group, children were given a bubble toy during the procedure and asked to blow bubbles. This method, which requires active motor participation, was used to divert the children's attention away from the stress of the procedure. | Other | Bubble Blowing Group |
| Positive Reinforcement GroupIn the Positive Reinforcement Group, children performed a non-material cognitive activity of their choice during the procedure (such as counting, reciting a short poem/song, or a word game). At the end of the procedure, verbal positive reinforcement was provided (e.g., "Well done," "You were very brave"). | Other | Positive Reinforcement Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
Developed by Wong and Baker (1988), this scale assesses pain intensity in children aged 3-18 years based on facial expressions, using a 0-5 scoring system. Pain intensity was assessed using the Wong-Baker FACES Pain Rating Scale (0-10; higher scores indicate worse pain).
Children's Fear and Anxiety Scale (CFS)
Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the procedure.
Developed by McMurtry et al. (2011) and adapted into Turkish by Gerçeker et al. (2018), this scale evaluates fear and anxiety during the procedure on a 0-4 rating scale. 0-10; higher scores indicate greater fear and anxiety.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the 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 3 Dec 2025.
- Background: PubMed 34362032Czech O, Wrzeciono A, Rutkowska A, Guzik A, Kiper P, Rutkowski S. Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jul 23;10(15):3248. doi: 10.3390/jcm10153248.
- Background: PubMed 2197679Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
- Background: PubMed 36737707Yu Z, Zhou Y, Xu X, Lin L, Le Q, Gu Y. Pharmacological and non-pharmacological interventions in management of peripheral venipuncture-related pain: a randomized clinical trial. BMC Pediatr. 2023 Feb 3;23(1):58. doi: 10.1186/s12887-023-03855-z.
- 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 31335787Lawson SL, Hogg MM, Moore CG, Anderson WE, Osipoff PS, Runyon MS, Reynolds SL. Pediatric Pain Assessment in the Emergency Department: Patient and Caregiver Agreement Using the Wong-Baker FACES and the Faces Pain Scale-Revised. Pediatr Emerg Care. 2021 Dec 1;37(12):e950-e954. doi: 10.1097/PEC.0000000000001837.
- Background: PubMed 30362982Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.
- BackgroundGerçeker, G.Ö., Ayar, D., Özdemir, E. Z., & Bektaş, M. (2018). Gaining of Children's state anxiety and Children's fear scale to Turkish language. E- Journal of Dokuz Eylul University Nursing Faculty, 11(1), 9-13. https://dergipark.org.tr/tr/pub/deuhfed/issue/46786/586670
- Background: PubMed 33485746Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.
- Background: PubMed 35068011Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.
- Derived from this study: PubMed 42414960Caka SY, Cebeci E, Kavi HO, Balikci N, Topal S. Comparison of the effectiveness of two active distraction methods in reducing pain, fear, and anxiety in children during venipuncture: a randomized controlled trial. BMC Pediatr. 2026 Jul 7. doi: 10.1186/s12887-026-07249-9. Online ahead of print.
- 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 Bubble Blowing Group and Positive Reinforcement Group in people with Nursing Care and Pain Management, run by Kocaeli 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 5 inclusion and 3 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 3 Dec 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?
Wong-Baker FACES Pain Rating Scale (WB-FACES) (time frame: A total of 2 evaluations will be made: before the procedure starts, the post-test immediately after the end of the 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 NCT07249723, which also lists 10 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 3 Dec 2025.