BloodlettingNCT05437146
The Effect of Therapeutic Play Applied With Puppet
A study testing puppet in people with Bloodletting, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of therapeutic play applied with a hand puppet during blood collection on pain and fear in children. The project is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Bloodletting
- What is being tested?
- puppet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2022to 28 Dec 2022
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- be between 3-6 years old
- Not having a disability related to developmental areas
- Not taking analgesics within 24 hours before application
- Being with the mother or father of the child during the procedure
Who cannot join
- Not between 3-6 years old
- Having a disability related to developmental areas
- Taking analgesics within 24 hours before admission
- Not being with the mother or father of the child during the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Therapeutic Play Applied With Puppet During Blood Collection in Children on Pain and Fear
The aim of this study is to determine the effect of therapeutic play applied with a hand puppet during blood collection on pain and fear in children. The project is a randomized controlled trial. The study includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022 and 01/01/2023. The research sample; children who apply to the unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Wong-Baker Evaluation of Facial Expressions Scale" and "Child Fear Scale" will be used in data collection.
Read the detailed description
Type of Study: The study is a randomized controlled trial. Population and Sample of the Research: The population of the research includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022-01/01/2023.
The research sample; "Children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research". In this study, "prior power analysis" was conducted to determine sample adequacy. In the Priori power analysis, "Cohen's method of reference to standard effect sizes" was chosen. In this case, in our study, the effect of the therapeutic game applied with a hand puppet during blood collection on pain and fear in children will be compared. It has been determined that 80% power can be reached. It was decided to collect data from a total of 100 individuals by including 10% backup sample in this number in case of data loss. Data collection will not be carried out simultaneously in the puppet and control groups, in case the children in the clinic are affected by the puppet toys. In order to ensure randomization, the children who met the criteria will be included in the control group in the first week, and the children who come in the second week will be taken into the puppet group, and this cycle will be continued until the end of the study, and randomization will be ensured.
Data Collection Tools to be Used in the Study: "Survey Form, Wong-Baker Facial Expression Evaluation Scale and Child Fear Scale" will be used to collect research data. As an intervention tool in the research, a hand puppet designed together with the researcher and child development specialist will be used.
Questionnaire Form: In the questionnaire form created by the researchers by scanning the literature; There are questions addressing the introductory characteristics of the research group.
Intervention Tools to be Used in the Research Hand puppet: A hand puppet designed together with the researcher and child development specialist will be used as an intervention tool in the research. In this context, the researcher received play therapy training. While the puppet is being designed, it will be ensured that it is integrated in the hospital environment and it will be ensured that the child is not alienated to the environment he/she comes from. The researcher, who received play therapy training in hand puppet practice, plans to reduce the children's fears and reduce the level of pain before the intervention. While designing the hand puppet, care will be taken to ensure that the materials to be used are antiallergenic and made of fabric that can be easily sterilized after each child the application is made.
Data Collection The researcher will stay in the pediatric blood collection unit for 1 day in order to examine the ergonomic structure of the pediatric blood collection unit before collecting the data of the puppet group and control group children. Parents were informed about the research (the purpose of the research, why the research was conducted, the use of a puppet toy to relieve the child's pain and fear, etc.), after giving verbal consent from the children and written consent from the parents. Afterwards, the data of the research will be obtained by face-to-face interview method with the children who accepted to participate in the research.
Control Group: Questionnaires and scales will be filled in the control group 5 minutes before the blood draw is done by the researcher. Only routine applications will be made. 5 minutes after the procedure, the scales will be filled again. Filling out the forms will take 5-10 minutes on average.
Puppet Group: Questionnaires and scales will be filled in 5 minutes before the blood draw is done by the researcher. It will be played with the puppet during the process. 5 minutes after the procedure, the scales will be filled again. Filling out the forms will take 5-10 minutes on average.
Evaluation of Data The processing and statistical analysis of the collected data will be done with the analysis software called SPSS (Statistical Package for the Social Sciences) for Windows 20.0.
Ethical Principles of Research In order to carry out the research, official permission from the relevant institution will be obtained from the Ethics Committee with ethical approval. Children who meet the criteria of the research group will be informed about the purpose of the study, their questions will be answered, and their verbal and written consent will be obtained. Parents and children will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed. After the blood collection process is completed, the children in the control group will be played with a puppet and the "Principle of Equality" will be tried to be fulfilled.
- Conditions
- Bloodletting
- Being tested
- puppet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
puppetBehavioural
pain and fear during blood collection
| Study group | Role | What they receive |
|---|---|---|
| Puppet | Experimental | pain and fear Receives: Behavioral: puppet |
| control | No intervention | not pain and fear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Evaluation Scale (WB-FAI)
The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Measured: 9 MONTHS
Child Fear Scale (CFS):
The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start19 Jun 2022
- Primary completion27 Oct 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodlettingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437146
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/449
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play Applied With Puppet During Blood Collection in Children on Pain and Fear
- ClinicalTrials.gov ID
- NCT05437146
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/449
- Conditions
- Bloodletting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 29 Jun 2022 (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 is to determine the effect of therapeutic play applied with a hand puppet during blood collection on pain and fear in children. The project is a randomized controlled trial. The study includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022 and 01/01/2023. The research sample; children who apply to the unit on the specified dates and meet the research criteria and volunteer to participate in the research. "Survey Form", "Wong-Baker Evaluation of Facial Expressions Scale" and "Child Fear Scale" will be used in data collection.
Detailed description
Type of Study: The study is a randomized controlled trial. Population and Sample of the Research: The population of the research includes children aged 3-6 years who came to the pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital between 01/07/2022-01/01/2023.
The research sample; "Children who apply to the blood collection unit on the specified dates and meet the research criteria and volunteer to participate in the research". In this study, "prior power analysis" was conducted to determine sample adequacy. In the Priori power analysis, "Cohen's method of reference to standard effect sizes" was chosen. In this case, in our study, the effect of the therapeutic game applied with a hand puppet during blood collection on pain and fear in children will be compared. It has been determined that 80% power can be reached. It was decided to collect data from a total of 100 individuals by including 10% backup sample in this number in case of data loss. Data collection will not be carried out simultaneously in the puppet and control groups, in case the children in the clinic are affected by the puppet toys. In order to ensure randomization, the children who met the criteria will be included in the control group in the first week, and the children who come in the second week will be taken into the puppet group, and this cycle will be continued until the end of the study, and randomization will be ensured.
Data Collection Tools to be Used in the Study: "Survey Form, Wong-Baker Facial Expression Evaluation Scale and Child Fear Scale" will be used to collect research data. As an intervention tool in the research, a hand puppet designed together with the researcher and child development specialist will be used.
Questionnaire Form: In the questionnaire form created by the researchers by scanning the literature; There are questions addressing the introductory characteristics of the research group.
Intervention Tools to be Used in the Research Hand puppet: A hand puppet designed together with the researcher and child development specialist will be used as an intervention tool in the research. In this context, the researcher received play therapy training. While the puppet is being designed, it will be ensured that it is integrated in the hospital environment and it will be ensured that the child is not alienated to the environment he/she comes from. The researcher, who received play therapy training in hand puppet practice, plans to reduce the children's fears and reduce the level of pain before the intervention. While designing the hand puppet, care will be taken to ensure that the materials to be used are antiallergenic and made of fabric that can be easily sterilized after each child the application is made.
Data Collection The researcher will stay in the pediatric blood collection unit for 1 day in order to examine the ergonomic structure of the pediatric blood collection unit before collecting the data of the puppet group and control group children. Parents were informed about the research (the purpose of the research, why the research was conducted, the use of a puppet toy to relieve the child's pain and fear, etc.), after giving verbal consent from the children and written consent from the parents. Afterwards, the data of the research will be obtained by face-to-face interview method with the children who accepted to participate in the research.
Control Group: Questionnaires and scales will be filled in the control group 5 minutes before the blood draw is done by the researcher. Only routine applications will be made. 5 minutes after the procedure, the scales will be filled again. Filling out the forms will take 5-10 minutes on average.
Puppet Group: Questionnaires and scales will be filled in 5 minutes before the blood draw is done by the researcher. It will be played with the puppet during the process. 5 minutes after the procedure, the scales will be filled again. Filling out the forms will take 5-10 minutes on average.
Evaluation of Data The processing and statistical analysis of the collected data will be done with the analysis software called SPSS (Statistical Package for the Social Sciences) for Windows 20.0.
Ethical Principles of Research In order to carry out the research, official permission from the relevant institution will be obtained from the Ethics Committee with ethical approval. Children who meet the criteria of the research group will be informed about the purpose of the study, their questions will be answered, and their verbal and written consent will be obtained. Parents and children will be informed that the data collected during the research will be processed anonymously, confidentially, and will not be used outside of the study in question, and that they can leave the study whenever they wish. Since the research is based on the use of data obtained from humans, and therefore, due to the necessity of observing personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and "Protection of Confidentiality" will be followed. After the blood collection process is completed, the children in the control group will be played with a puppet and the "Principle of Equality" will be tried to be fulfilled.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puppet | Experimental | Behavioral: puppetpain and fear |
| control | No intervention | –not pain and fear |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- be between 3-6 years old
- Not having a disability related to developmental areas
- Not taking analgesics within 24 hours before application
- Being with the mother or father of the child during the procedure
Key exclusion criteria (4 listed)
- Not between 3-6 years old
- Having a disability related to developmental areas
- Taking analgesics within 24 hours before admission
- Not being with the mother or father of the child during the procedure
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 |
|---|---|---|
| puppetpain and fear during blood collection | Behavioural | Puppet |
Primary outcome
Wong-Baker Facial Expression Evaluation Scale (WB-FAI)
Time frame: 9 MONTHS
The scale was developed in 1981 and was revised in 1983. The scale is used to define pain in the 3-18 age group. The scale indicates that the severity of pain increases from zero to five as you go from left to right. Facial expressions are included under the numbers to describe the severity of pain. It consists of 6 faces in total. While the first smiling facial expression expresses the pain-free state, the crying facial expression at the end indicates the most severe pain intensity. While applying the scale, the child is told to choose the facial expression that best describes his feelings at the moment. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, the pain tolerance decreases, and as the score decreases, the tolerance increases.
Child Fear Scale (CFS):
Time frame: 9 MONTHS
The scale was developed in 2011. The Child Fear Scale is used to determine the level of fear in children undergoing painful medical procedures. The Child Fear Scale is a scale from 0-4 showing five faces ranging from a neutral expression (0 = no worry) to the feared face (4 = serious anxiety).
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 4 Apr 2023.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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.
ARZU SARIALİOĞLU, PHD study director
Ataturk 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 puppet in people with Bloodletting, run by Ataturk 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 4 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: finished, as of the sponsor's last update on 4 Apr 2023. 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 Facial Expression Evaluation Scale (WB-FAI) (time frame: 9 MONTHS). 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?
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 4 Apr 2023.