Blood CollectionNCT07044713
Use of Hand Puppets and Image Watching and Coloring Books for Children in During Blood Collection Procedures
A study testing Hand Puppet and The Visual Viewing and Coloring Book in people with Blood Collection, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare a hand puppet with image viewing and a coloring book for children in reducing children's pain and fear during blood collection. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Blood Collection
- What is being tested?
- Hand Puppet and The Visual Viewing and Coloring Book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 3-6 years old
- Taking blood samples at once
- No visual-auditory and speech disorders
- Being open to communication and
- Being accompanied by a parent.
Who cannot join
- Having a chronic disease
- Having a visual-auditory and speech disorder
- History of sedative, analgesic or narcotic substance use within 24 hours before admission
- Children whose parents do not agree to participate in the study.
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
Kilis Prof. Dr. Alaeddin Yavaşca State Hospital
Kilis, Central, 79000
Elif Simay KOÇ, 2, +903488142666, elifsimay.koc@kilis.edu.tr
About this study
Official title: A Comparison of the Use of Hand Puppets and Image Watching and Coloring Books for Children in Reducing Pain and Fear During Blood Collection Procedures
The aim of this study was to compare a hand puppet with image viewing and a coloring book for children in reducing children's pain and fear during blood collection.
Read the detailed description
Ninety volunteer children aged 3-6 coming for blood collection will be randomly divided into three groups: hand puppet, viewing and painting the image, and control group. Children will be assessed before, during, and after the procedure. Pain related to blood collection will be assessed with the Wong-Baker Faces Pain Scale, and fear will be assessed with the Child Fear Scale. In addition, children's demographic data will be recorded in the Information Form.
- Conditions
- Blood Collection
- Being tested
- Hand Puppet, The Visual Viewing and Coloring Book
- Keywords
- blood collection, fear, child, pain, hand puppet, Tracing and Painting the Image
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand PuppetOther
Children who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the hand puppet group. The scales will be filled out by the nurse and the child five minutes before the blood collection. The researcher will benefit from the experiences of the child development specialist and preschool teacher before the research on puppet scenarios. In the interview room outside the blood collection unit, the child's parent will be asked to tell the researcher about the things the child enjoys and likes. The researcher will show the child puppet characters on various themes and the child will be asked to choose the puppet character he/she wants before the blood collection. The puppet scenarios will be improvised in light of the information received from the child's mother and father during the demonstration and will be shaped according to the child's wishes. In this way, the child will turn the scary hospital environment into an entertaining environm
The Visual Viewing and Coloring BookOther
Children who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the coloring group. The scales will be filled out by the nurse and the child five minutes before the blood is drawn. The Visual Viewing and Coloring Book consists of pictures that require coloring. The children will be given a book before the blood is drawn and will be asked to draw or color a picture as they prefer during the procedure. The fear scale will be assessed by the nurse and the child five minutes before, during, and five minutes after the procedure. The pain scale will be assessed by the nurse and the child during and five minutes after the procedure. The child will be shown the facial expressions on both the fear scale and the pain scale and asked which one it is, and the score corresponding to the facial expression he/she indicates will be recorded. Mothers will stay with their children during the treatment proce
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Before blood collection, the child will be shown games with hand puppets and will be asked to watch the image and color with the Coloring Book. Receives: Other: Hand Puppet; Other: The Visual Viewing and Coloring Book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
It is a form consisting of 7 questions in total, including the child's age, gender, previous hospital experience, if any, how many times the child has been hospitalized, whether the parents have prepared for the blood collection process beforehand, experience of having blood drawn in the last six months, and reactions to the blood collection process. It was prepared by researchers in accordance with the literature.
Measured: Baseline
Wong Baker Face Pain Scale
Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales. In our study, the child will be shown the facial expressions on the pain scale and asked which one it is, and the score co
Measured: Baseline and up to 4 weeks
Child Fear Scale
The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure. In our study, the child will be shown the facial expressions on the
Measured: Baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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 Blood CollectionStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Akay, Artvin Coruh University
- Investigators
- Gamze AKAY, 1, Principal investigator, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044713
- Sponsor's protocol ID
- Hand Puppets, Image Watching
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oluc T, Sarialioglu A. The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure. J Pediatr Nurs. 2023 Sep-Oct;72:e80-e86. doi: 10.1016/j.pedn.2023.06.012. Epub 2023 Jun 15.
PubMed 37330277
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Use of Hand Puppets and Image Watching and Coloring Books for Children in Reducing Pain and Fear During Blood Collection Procedures
- ClinicalTrials.gov ID
- NCT07044713
- Acronym / sponsor ID
- Hand Puppets, Image Watching
- Conditions
- Blood Collection
- Keywords
- blood collection, fear, child, pain, hand puppet, Tracing and Painting the Image
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 1 Jul 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.
The aim of this study was to compare a hand puppet with image viewing and a coloring book for children in reducing children's pain and fear during blood collection.
Detailed description
Ninety volunteer children aged 3-6 coming for blood collection will be randomly divided into three groups: hand puppet, viewing and painting the image, and control group. Children will be assessed before, during, and after the procedure. Pain related to blood collection will be assessed with the Wong-Baker Faces Pain Scale, and fear will be assessed with the Child Fear Scale. In addition, children's demographic data will be recorded in the Information Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Hand Puppet, Other: The Visual Viewing and Coloring BookBefore blood collection, the child will be shown games with hand puppets and will be asked to watch the image and color with the Coloring Book. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between 3-6 years old
- Taking blood samples at once
- No visual-auditory and speech disorders
- Being open to communication and
- Being accompanied by a parent.
Key exclusion criteria (4 listed)
- Having a chronic disease
- Having a visual-auditory and speech disorder
- History of sedative, analgesic or narcotic substance use within 24 hours before admission
- Children whose parents do not agree to participate in the study.
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 |
|---|---|---|
| Hand PuppetChildren who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the hand puppet group. The scales will be filled out by the nurse and the child five minutes before the blood collection. The researcher will benefit from the experiences of the child development specialist and preschool teacher before the research on puppet scenarios. In the interview room outside the blood collection unit, the child's parent will be asked to tell the researcher about the things the child enjoys and likes. The researcher will show the child puppet characters on various themes and the child will be asked to choose the puppet character he/she wants before the blood collection. The puppet scenarios will be improvised in light of the information received from the child's mother and father during the demonstration and will be shaped according to the child's wishes. In this way, the child will turn the scary hospital environment into an entertaining environm | Other | Experimental Group |
| The Visual Viewing and Coloring BookChildren who come to the hospital's blood collection unit and meet the research criteria will be randomly assigned to the coloring group. The scales will be filled out by the nurse and the child five minutes before the blood is drawn. The Visual Viewing and Coloring Book consists of pictures that require coloring. The children will be given a book before the blood is drawn and will be asked to draw or color a picture as they prefer during the procedure. The fear scale will be assessed by the nurse and the child five minutes before, during, and five minutes after the procedure. The pain scale will be assessed by the nurse and the child during and five minutes after the procedure. The child will be shown the facial expressions on both the fear scale and the pain scale and asked which one it is, and the score corresponding to the facial expression he/she indicates will be recorded. Mothers will stay with their children during the treatment proce | Other | Experimental Group |
Primary outcome
Patient Identification Form
Time frame: Baseline
It is a form consisting of 7 questions in total, including the child's age, gender, previous hospital experience, if any, how many times the child has been hospitalized, whether the parents have prepared for the blood collection process beforehand, experience of having blood drawn in the last six months, and reactions to the blood collection process. It was prepared by researchers in accordance with the literature.
Wong Baker Face Pain Scale
Time frame: Baseline and up to 4 weeks
Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales. In our study, the child will be shown the facial expressions on the pain scale and asked which one it is, and the score co
Child Fear Scale
Time frame: Baseline and up to 4 weeks
The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure. In our study, the child will be shown the facial expressions on the
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 1 Jul 2025.
- Results publication: PubMed 37330277Oluc T, Sarialioglu A. The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure. J Pediatr Nurs. 2023 Sep-Oct;72:e80-e86. doi: 10.1016/j.pedn.2023.06.012. Epub 2023 Jun 15.
- Randomized Controlled TrialLink provided by the sponsor.
- 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.
Gamze AKAY, 1 principal investigator
Artvin Coruh 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 Hand Puppet and The Visual Viewing and Coloring Book in people with Blood Collection, run by Artvin Coruh 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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 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?
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 Gamze AKAY, 1 (+905314536661, gamzeakay_25@artvin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT07044713, 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 1 Jul 2025.