AnxietyNCT06361069
Reducing Anxiety in Children Undergoing Day Surgery
A study testing distraction cards, kaleidoscope and finger puppet in people with Anxiety and Child, Only, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anxiety, Child, Only, Surgery
- What is being tested?
- distraction cards, kaleidoscope and finger puppet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Jan 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-12 years
- scheduled for day surgery
- devoid of prior surgical experiences
- willingly consented to participation.
Who cannot join
- children undergoing major surgeries (e.g., cardiac procedures)
- emergency surgical interventions
- individuals with mental retardation
- as well as those with visual or auditory impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Finger Puppets, Distraction Cards and Kaleidoscope for Reducing Anxiety in Children Undergoing Day Surgery
Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.
Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data.
Read the detailed description
This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.
The study was carried out from April 2023 to January 2024, involving children aged 6-12 years admitted to the pediatric clinic of a teaching and research hospital for day surgery (tonsillectomy, circumcisio, adenotonsillectomy etc.). Notably, the nursing care provided at the hospital does not incorporate distraction techniques aimed at alleviating anxiety in children.
Sample The sample required for the study was calculated using the G*Power (3.1.9.4) computer program. Based on the Type I error of 5%, Type II error of 99%, SD = 6.20, and Type I error of 5% in the study by Dehghan et al. (2017), the desired effect size for this study was 0.55 and the total required sample size was 64 children (approximately 21 children for each group) (Dehghan et al., 2017). A total of 85 children, comprising 20 children in the control group, 22 in the finger puppet intervention group, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group, was recruited from the pediatric clinic between April 2023 and January 2024, meeting the study's inclusion criteria. Notably, no randomization method was employed in the selection process.
- Conditions
- Anxiety, Child, Only, Surgery
- Being tested
- distraction cards, kaleidoscope and finger puppet
- Keywords
- Anxiety, Child, Day surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distraction cards, kaleidoscope and finger puppetOther
A kaleidoscope, characterized by vibrant patterns visible through rotation of its cylinders, operates on the principle of light refraction, producing dynamic and ever-changing visual displays.
Distraction cards feature an array of images and shapes, each measuring approximately 5-8 cm in length. These intricate designs are discernible only upon careful examination of the cards.
Puppets, as a therapeutic intervention tool, significantly influence children's personal, social, and emotional development, facilitating their comfortable expression of emotions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 20 children in the control group |
| Experimental group | Experimental | 22 in the finger puppet, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group Receives: Other: distraction cards, kaleidoscope and finger puppet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Apr 2023
- Primary completion1 Aug 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Akdeniz Kudubeş, Bilecik Seyh Edebali Universitesi
- Investigators
- ASLI AKDENİZ KUDUBEŞ, phd, Principal investigator, BİLECİK ŞEYH EDEBALİ UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361069
- Sponsor's protocol ID
- aslıakdeniz
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 11 Apr 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Finger Puppets, Distraction Cards and Kaleidoscope for Reducing Anxiety in Children Undergoing Day Surgery
- ClinicalTrials.gov ID
- NCT06361069
- Acronym / sponsor ID
- aslıakdeniz
- Conditions
- Anxiety, Child, Only, Surgery
- Keywords
- Anxiety, Child, Day surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 11 Apr 2024 (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.
Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.
Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data.
Detailed description
This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.
The study was carried out from April 2023 to January 2024, involving children aged 6-12 years admitted to the pediatric clinic of a teaching and research hospital for day surgery (tonsillectomy, circumcisio, adenotonsillectomy etc.). Notably, the nursing care provided at the hospital does not incorporate distraction techniques aimed at alleviating anxiety in children.
Sample The sample required for the study was calculated using the G*Power (3.1.9.4) computer program. Based on the Type I error of 5%, Type II error of 99%, SD = 6.20, and Type I error of 5% in the study by Dehghan et al. (2017), the desired effect size for this study was 0.55 and the total required sample size was 64 children (approximately 21 children for each group) (Dehghan et al., 2017). A total of 85 children, comprising 20 children in the control group, 22 in the finger puppet intervention group, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group, was recruited from the pediatric clinic between April 2023 and January 2024, meeting the study's inclusion criteria. Notably, no randomization method was employed in the selection process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –20 children in the control group |
| Experimental group | Experimental | Other: distraction cards, kaleidoscope and finger puppet22 in the finger puppet, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 6-12 years
- scheduled for day surgery
- devoid of prior surgical experiences
- willingly consented to participation.
Key exclusion criteria (4 listed)
- children undergoing major surgeries (e.g., cardiac procedures)
- emergency surgical interventions
- individuals with mental retardation
- as well as those with visual or auditory impairments.
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 |
|---|---|---|
| distraction cards, kaleidoscope and finger puppetA kaleidoscope, characterized by vibrant patterns visible through rotation of its cylinders, operates on the principle of light refraction, producing dynamic and ever-changing visual displays. Distraction cards feature an array of images and shapes, each measuring approximately 5-8 cm in length. These intricate designs are discernible only upon careful examination of the cards. Puppets, as a therapeutic intervention tool, significantly influence children's personal, social, and emotional development, facilitating their comfortable expression of emotions. | Other | Experimental group |
Primary outcome
Anxiety
Time frame: up to 10 months
This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery
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 11 Apr 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.
ASLI AKDENİZ KUDUBEŞ, phd principal investigator
BİLECİK ŞEYH EDEBALİ 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 distraction cards, kaleidoscope and finger puppet in people with Anxiety and Child, Only, run by Bilecik Seyh Edebali Universitesi 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 11 Apr 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?
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?
Anxiety (time frame: up to 10 months). 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 11 Apr 2024.