Procedural PainNCT05073497
Efficacy of Finger Puppet as a Distraction Method
A study testing Finger puppets in people with Procedural Pain and Pain, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted with the randomized controlled experimental method. The children who attended the pediatric emergency department will divide into two groups via randomization in the computer environment. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Procedural Pain, Pain, Acute Pain
- What is being tested?
- Finger puppets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 31 Mar 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
- Being between the ages of 3 and 6,
- Having body temperature at normal level (36.5-37.2oC),
- Having no disease that can cause acute or chronic pain,
- Having no auditory, mental, and neurological disability that can affect their participation,
- Having no confusion.
Who cannot join
- Being younger than 3 years old and older than 6 years old,
- Having body temperature at a higher than normal level,
- Having a disease that can cause acute or chronic pain,
- Having auditory, mental, and neurological disability that can affect their participation,
- Having confusion.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Kartal
About this study
Official title: The Effect of Finger Puppet on Children's Pain and Emotional Indicators Undergoing Venipuncture in Pediatric Emergency Department
The study will be conducted with the randomized controlled experimental method. The children who attended the pediatric emergency department will divide into two groups via randomization in the computer environment. After the randomization, children in the experimental group will play with finger puppets under the direction of the researcher during venipuncture. On the other hand, no application will perform on the children in the control group during the venipuncture. The parents will also be found next to their children in both groups during the procedure.
Read the detailed description
Many different non-pharmacological methods are used to cope with negative situations such as pain, fear and anxiety caused by invasive procedures in children. One of these non-pharmacological methods is the distraction. The American Pain Society recommends the use of distraction for pain control in children. With the distraction method, the child's pain is controlled and reduced by focusing the child's attention in another direction. Video games, virtual reality glasses, listening to music, watching cartoons, blowing balloons, reading books, playing with puppet/finger puppets are used as distraction methods. The aim of this study is to determine the effect of distraction method applied with finger puppet on the child's pain level and emotional indicators in children aged 3-6 years who applied to the pediatric emergency department and underwent venous blood collection. The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 76 children including minimum of 38 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 80 children including 40 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and Children's Emotional Manifestation Scale will use for data collection. Children and their parents who applied to the pediatric emergency unit will inform about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure. One minute before the procedure children in the experimental group will start to play with finger puppets under the direction of the researcher. The researcher will continue to distract the child's attention during the procedure with finger puppets. For distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing. Children in the control group will be given routine practices and no distraction method will be applied. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.
- Conditions
- Procedural Pain, Pain, Acute Pain
- Being tested
- Finger puppets
- Keywords
- Distraction, Finger puppet, pain management, procedural pain
- Medical subject headings
- Pain, Procedural, Pain, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger puppetsOther
In the experimental group, for distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing before and during venipuncture.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | One minute before the procedure the children in the experimental group will start to play with finger puppets under the direction of the researcher. The researcher will continue to distract the child's attention during the procedure with finger puppets. Receives: Other: Finger puppets |
| Control Group | No intervention | No intervention will perform to reduce pain in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain from before venipuncture to during venipuncture
Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.
Measured: Before venipuncture procedure and within 2 minutes after the venipuncture procedure
Secondary outcomes (1)
Change of emotional status from before venipuncture to during venipuncture
Children's emotional status will assess by the healthcare provider who performs the venipuncture procedure with the Children's Emotional Manifestation Scale. This scale was developed to objectively evaluate children's emotional behaviors towards medical procedures. In the scale, emotional indicators are evaluated according to 5 parameters (facial expression, voice, activity, interaction, cooperation level). These five parameters are scored from 1 to 5, with the lowest '5' and the highest '25' points. A high score on the scale indicates that the child displays more negative emotional behavior during the procedure.
Measured: Before venipuncture procedure and and within 2 minutes after the venipuncture procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start15 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Biruni University
- Investigators
- Zeynep Erkut, PhD, Principal investigator, Maltepe UniversityMurat Ceylan, RN, Principal investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073497
- Sponsor's protocol ID
- 2021/51-34
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2021
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Finger Puppet on Children's Pain and Emotional Indicators Undergoing Venipuncture in Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05073497
- Acronym / sponsor ID
- 2021/51-34
- Conditions
- Procedural Pain, Pain, Acute Pain
- Keywords
- Distraction, Finger puppet, pain management, procedural pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 11 Oct 2021 (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 study will be conducted with the randomized controlled experimental method. The children who attended the pediatric emergency department will divide into two groups via randomization in the computer environment. After the randomization, children in the experimental group will play with finger puppets under the direction of the researcher during venipuncture. On the other hand, no application will perform on the children in the control group during the venipuncture. The parents will also be found next to their children in both groups during the procedure.
Detailed description
Many different non-pharmacological methods are used to cope with negative situations such as pain, fear and anxiety caused by invasive procedures in children. One of these non-pharmacological methods is the distraction. The American Pain Society recommends the use of distraction for pain control in children. With the distraction method, the child's pain is controlled and reduced by focusing the child's attention in another direction. Video games, virtual reality glasses, listening to music, watching cartoons, blowing balloons, reading books, playing with puppet/finger puppets are used as distraction methods. The aim of this study is to determine the effect of distraction method applied with finger puppet on the child's pain level and emotional indicators in children aged 3-6 years who applied to the pediatric emergency department and underwent venous blood collection. The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 76 children including minimum of 38 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 80 children including 40 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and Children's Emotional Manifestation Scale will use for data collection. Children and their parents who applied to the pediatric emergency unit will inform about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure. One minute before the procedure children in the experimental group will start to play with finger puppets under the direction of the researcher. The researcher will continue to distract the child's attention during the procedure with finger puppets. For distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing. Children in the control group will be given routine practices and no distraction method will be applied. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Finger puppetsOne minute before the procedure the children in the experimental group will start to play with finger puppets under the direction of the researcher. The researcher will continue to distract the child's attention during the procedure with finger puppets. |
| Control Group | No intervention | –No intervention will perform to reduce pain in the control group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between the ages of 3 and 6,
- Having body temperature at normal level (36.5-37.2oC),
- Having no disease that can cause acute or chronic pain,
- Having no auditory, mental, and neurological disability that can affect their participation,
- Having no confusion.
Key exclusion criteria (5 listed)
- Being younger than 3 years old and older than 6 years old,
- Having body temperature at a higher than normal level,
- Having a disease that can cause acute or chronic pain,
- Having auditory, mental, and neurological disability that can affect their participation,
- Having confusion.
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 |
|---|---|---|
| Finger puppetsIn the experimental group, for distraction the researcher will put finger puppets consisting of various animal figures on his finger, and will ask the child to imitate these sounds by making animal-specific sounds that he moves with his finger. The researcher will also draw the child's attention to finger puppets by using methods such as making animals talk to each other and singing before and during venipuncture. | Other | Experimental Group |
Primary outcome
Change of pain from before venipuncture to during venipuncture
Time frame: Before venipuncture procedure and within 2 minutes after the venipuncture procedure
Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.
1 secondary outcome
Change of emotional status from before venipuncture to during venipuncture
Time frame: Before venipuncture procedure and and within 2 minutes after the venipuncture 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 1 Apr 2022.
- 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.
Zeynep Erkut, PhD principal investigator
Maltepe University
Murat Ceylan, RN principal investigator
Dr. Lutfi Kirdar Kartal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger puppets in people with Procedural Pain and Pain, run by Biruni 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: finished, as of the sponsor's last update on 1 Apr 2022. 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?
Change of pain from before venipuncture to during venipuncture (time frame: Before venipuncture procedure and within 2 minutes after the venipuncture procedure). 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 1 Apr 2022.