Pain, AcuteSC-puppetNCT06013501
The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia
A study testing puppet show in people with Pain, Acute and Fear, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pain, Acute, Fear
- What is being tested?
- puppet show
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2023to 3 Dec 2024
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child <3 and >7 years old
- Medically unstable (dehydration, septic shock, sedation)
- Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study.
Who cannot join
- Not exposed to any other interventional procedure before (same day) subcutaneous intervention
- Not expressing any pain before subcutaneous intervention
- Heart rate to be within age-appropriate limits
- Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago)
- Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment)
- The child and family do not know Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülçin Özalp Gerçeker
Izmir, 35100
Gülçin Ö Gerçeker, 05306411368, gulcinozalp@gmail.com
About this study
Official title: The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
This study aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.
Read the detailed description
Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.
- Conditions
- Pain, Acute, Fear
- Being tested
- puppet show
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
puppet showBehavioural
puppet show to the child before and during subcutaneous application
| Study group | Role | What they receive |
|---|---|---|
| Puppet Show Group | Experimental | puppet show before and during subcutaneous injection Receives: Behavioral: puppet show |
| Control group | No intervention | standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure-related pain with Wong Baker Pain Rating Scale
pain assessment with Wong Baker Pain Rating Scale by child
Measured: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
procedure-related fear with Child Fear Scale
fear assessment with Child Fear Scale by child and parent
Measured: change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse
Measured: change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
Secondary outcomes (1)
Heart rate
Heart rate measurement
Measured: change from the heart rate at 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start3 Jan 2023
- Primary completion3 Dec 2024 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Crossover
- Model description
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, pHD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013501
- Sponsor's protocol ID
- SC-puppet
- Acronym
- SC-puppet
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2023
- Last updated
- 5 Feb 2024
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06013501
- Acronym / sponsor ID
- SC-puppet / SC-puppet
- Conditions
- Pain, Acute, Fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 28 Aug 2023 (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 aim to evaluate the effect of puppet show applied during subcutaneous injection to children aged 3-7 years with leukemia on the level of pain and fear experienced by children due to the intervention.
Detailed description
Before and during subcutaneous injection administration to the children in the study group There will be a puppet show. No distraction method will be applied to the children in the control group and the clinical A subcutaneous injection will be administered in accordance with the routine. Pain and fear assessment of children in both groups will be evaluated by the clinical nurse during the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised
| Arm | Type | Receives |
|---|---|---|
| Puppet Show Group | Experimental | Behavioral: puppet showpuppet show before and during subcutaneous injection |
| Control group | No intervention | –standart care |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child <3 and >7 years old
- Medically unstable (dehydration, septic shock, sedation)
- Children who are being treated for leukemia in the Pediatric Hematology Service will be included in the study.
Key exclusion criteria (6 listed)
- Not exposed to any other interventional procedure before (same day) subcutaneous intervention
- Not expressing any pain before subcutaneous intervention
- Heart rate to be within age-appropriate limits
- Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the subcutaneous intervention (5 minutes ago)
- Having a disability that cannot perceive the attempt and communicate (down syndrome, speech disorder, visual impairment)
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 |
|---|---|---|
| puppet showpuppet show to the child before and during subcutaneous application | Behavioural | Puppet Show Group |
Primary outcome
procedure-related pain with Wong Baker Pain Rating Scale
Time frame: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
pain assessment with Wong Baker Pain Rating Scale by child
procedure-related fear with Child Fear Scale
Time frame: change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
fear assessment with Child Fear Scale by child and parent
procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
Time frame: change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse
1 secondary outcome
Heart rate
Time frame: change from the heart rate at 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
Gülçin Özalp Gerçeker, pHD principal investigator
Dokuz Eylul 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 show in people with Pain, Acute and Fear, run by Dokuz Eylul 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülçin Özalp Gerçeker, pHD (905306411368, gulcinozalp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure-related pain with Wong Baker Pain Rating Scale (time frame: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)). 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 5 Feb 2024.