Blood SamplingPhase 1NCT07731347
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
A Phase 1 study testing experimental group and experiment group in people with Blood Sampling and Child, Only, run by Igdir University at 1 site in Turkey (Türkiye).
Trial summary
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sampling, Child, Only, Pain
- What is being tested?
- experimental group and experiment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Dec 2026
- Phase
- Phase 1
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 5 and 7 years old,
- Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
- Having a level of consciousness suitable for communication,
- The child and their parents agreeing to participate in the study,
- Being able to communicate in Turkish.
Who cannot join
- Inability to participate in the application due to visual or hearing problems,
- Inability to administer the scales due to a developmental or neurological disease,
- Being under the influence of sedative or analgesic medication,
- Inability to complete the application during the research process,
- Lack of parental consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Igdır University
Iğdır, Iğdır, 76000
Eda Gülbetekin, 05398612688, edagulbetekin@gmail.com
About this study
Official title: The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
Read the detailed description
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.
- Conditions
- Blood Sampling, Child, Only, Pain, Fear, Nurse's Role
- Being tested
- experimental group, experiment group, Control Group
- Keywords
- Play Therapy, blood sampling, child, pain, fear, nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupCombination product
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.
The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation
experiment groupCombination product
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.
The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets
Control GroupCombination product
Before, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed.
The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: experimental group | Experimental | Distraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher.
355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation Receives: Combination Product: experimental group |
| Experimental: experimental 2 group | Experimental | Hand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method Receives: Combination Product: experiment group |
| Experimental: Experimental: Control Group | Experimental | Standart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions.
The working children will be randomly assigned to three groups:
Group 3 (Control): Routine clinical practice (without any therapeutic intervention) Receives: Combination Product: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC Pain Assessment Scale
This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child. These behaviors are scored using a scale of 0, 1, and 2 points. A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.
Measured: through study completion, an average of 1 year
Children's Fear Scale
The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions.
The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure.
Measured: through study completion, an average of 1 year
Child Anxiety Scale
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years. When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top. Then, the child is asked to indicate the level of anxiety or tension they feel with a line. The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018). The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SamplingStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Gulbetekin, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731347
- Sponsor's protocol ID
- Eda4
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Therapeutic Interventions on Pain, Anxiety and Fear During Venipuncture in Children
- ClinicalTrials.gov ID
- NCT07731347
- Acronym / sponsor ID
- Eda4
- Conditions
- Blood Sampling, Child, Only, Pain, Fear, Nurse's Role
- Keywords
- Play Therapy, blood sampling, child, pain, fear, nursing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jul 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 research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
Detailed description
This research is a three-group, randomized controlled experimental study designed to determine the effect of two different therapeutic interventions applied during blood sampling on pain, anxiety, and fear levels in children aged 5-7 years.
Children participating in the study will be randomly divided into three groups:
- Group (Experiment 1): Distraction method using betta fish observation
- Group (Experiment 2): Distraction method using hand puppets
- Group (Control): Routine clinical practice (without any therapeutic intervention) Before, during, and after blood sampling, children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be evaluated.
The obtained data will be compared using statistical analysis methods. The population of the study will consist of children aged 5-7 years who apply to the Pediatric Emergency Unit of Iğdır Dr. Nevruz Erez State Hospital and undergo venous blood sampling. The sample of the study will consist of children and their parents who meet the inclusion criteria and voluntarily agree to participate in the study. Children selected using an appropriate sampling method will be randomly assigned to three groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: experimental group | Experimental | Combination Product: experimental groupDistraction method using betta fish observation Participation in the study is entirely voluntary. After the purpose of the study is explained to the experimental group by the researcher and written and verbal permission is obtained from those who voluntarily agree to participate in the study, the pre-test data will be collected by the researcher. 355 This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling using two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 1 (Experiment 1): Distraction method using betta fish observation |
| Experimental: experimental 2 group | Experimental | Combination Product: experiment groupHand puppet distraction method This research is a carefully planned, three-group, randomized controlled study designed to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 2 (Experiment 2): Hand puppet distraction method |
| Experimental: Experimental: Control Group | Experimental | Combination Product: Control GroupStandart of care This research is a carefully planned, three-group, randomized controlled trial to determine the levels of pain, anxiety, and fear experienced by children aged 5-7 years during blood sampling with two different therapeutic interventions. The working children will be randomly assigned to three groups: Group 3 (Control): Routine clinical practice (without any therapeutic intervention) |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between 5 and 7 years old,
- Having a scheduled venous blood sampling procedure in the Pediatric Emergency Unit,
- Having a level of consciousness suitable for communication,
- The child and their parents agreeing to participate in the study,
- Being able to communicate in Turkish.
Key exclusion criteria (5 listed)
- Inability to participate in the application due to visual or hearing problems,
- Inability to administer the scales due to a developmental or neurological disease,
- Being under the influence of sedative or analgesic medication,
- Inability to complete the application during the research process,
- Lack of parental consent.
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 |
|---|---|---|
| experimental groupBefore, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 1 (Experiment 1): Distraction method using betta fish observation | Combination product | Experimental: experimental group |
| experiment groupBefore, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 2 (Experiment 2): Distraction method using hand puppets | Combination product | Experimental: experimental 2 group |
| Control GroupBefore, during, and after blood sampling, the children's pain level (FLACC scale), fear level (child fear scale), and anxiety level (child anxiety scale) will be assessed. The obtained data will be compared using statistical analysis methods. Group 3 (Control): Routine clinical practice (without any therapeutic intervention) | Combination product | Experimental: Experimental: Control Group |
Primary outcome
FLACC Pain Assessment Scale
Time frame: through study completion, an average of 1 year
This scale is a pain scale assess pain in children aged 2 months to 7 years.It evaluates leg movements, facial expression, crying, and soothing ability and activity behaviors in relation to the pain experienced by the child. These behaviors are scored using a scale of 0, 1, and 2 points. A score of '0' indicates the absence of pain, '1-3' indicates mild pain, '4-6' indicates moderate pain, and '7-10' indicates the presence of severe pain.
Children's Fear Scale
Time frame: through study completion, an average of 1 year
The scale is designed for children aged 5 to 10 years. A talented graphic artist developed visual depictions showing changes in facial muscles associated with fear, using photographs of individuals with anxious facial expressions. The scale can be used by parents, children, or researchers to assess children's fear levels. The child is presented with a scale consisting of five facial expressions, each scored between "0" and "4". A score of "0" indicates a fearless, neutral expression, while "4" represents the highest level of fear. The scores progress as follows: "0" (neutral statement/no fear), "1" (very little fear), "2" (some fear), "3" (more fear) and "4" (highest possible fear). This scale can be used to measure fear both before and during the procedure.
Child Anxiety Scale
Time frame: through study completion, an average of 1 year
The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years. When the scale is introduced to the child, it is stated that there is no anxiety, that anxiety increases as the scale moves upwards, and that the anxiety level is very high at the top. Then, the child is asked to indicate the level of anxiety or tension they feel with a line. The scale, developed by Ersig et al. (Ersig et al., 2013) in 2013, had its Turkish validity and reliability study conducted by Gerçeker et al. in 2018 (Gerçeker et al., 2018). The "Child Anxiety Scale-State (CAS-S)," which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4-10 years.
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 9 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing experimental group and experiment group in people with Blood Sampling and Child, Only, run by Igdir 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 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: looking for participants now, as of the sponsor's last update on 9 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eda Gülbetekin, Assoc. Prof. (05398612688, edagulbetekin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC Pain Assessment Scale (time frame: through study completion, an average of 1 year). The study lists 3 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 9 Sep 2026.