Anxiety and FearNCT06339047
The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children
A study testing Projector Kaleidoscope and Cartoon in people with Anxiety and Fear and Pain, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria. The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Anxiety and Fear, Pain, Surgery
- What is being tested?
- Projector Kaleidoscope and Cartoon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 19 Nov 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 4-10
- Having outpatient surgery
- Volunteering to participate in the study
Who cannot join
- Having had a previous surgical intervention
- Having a chronic disease
- The child has visual, hearing, and mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Projector Kaleidoscope and Cartoons in the Operating Room on Anxiety, Fear and Pain in Children Aged 4-10 Who Will Undergo Outpatient Surgery
The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.
The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.
In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used.
Read the detailed description
The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.
The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.
In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale, and Vital Signs Follow-up Form will be used.
Collection of Data The research will be implemented after ethics committee approval and written institutional permission are obtained.
Stage 1: By consulting experts on the subject, the researchers will create a pool of cartoons suitable for the level of children in the 4-10 age group that they can watch. The created children's cartoon pool will be sent to people who are experts in the field (child development specialists, child psychiatrists, and pediatric nurses).
Stage 2: Data collection forms to be used before the research. A pilot study will be conducted with 10 children to evaluate the suitability of the cartoon for children.
Stage 3: The children and their parents in the sample group will be informed about the method followed in the application and the research, and their verbal and written permissions will be obtained.
Stage 4: The introductory information form in the research will be applied to the children in the sample group.
Stage 5: Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria to 3 groups (1st experimental group, 2nd experimental control group and 3rd group control group) through a computer program.
(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). Stage 6: Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room. Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.
Stage 7: Before the surgery, the anxiety, fear and vital signs of the children in the sample will be evaluated. Children's fear assessment will be done by both the child and the nurse. Since parents are not allowed into the operating room, the evaluation will be made only by the child and the nurse.
Stage 8: In the postoperative period, the anxiety, fear, vital signs and pain of the children in the experimental and control groups will be recorded. Children's fear and pain assessment will be done by the child, nurse and parent.
Analysis of Research Data:
The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean, and standard deviation) will be used when evaluating the data. The suitability of the data used for normal distribution will be checked with kurtosis and skewness values. In comparing quantitative data with normally distributed data, an independent t-test will be used for the difference between two independent groups. In comparing more than two dependent groups, analysis of variance will be applied in repeated measurements and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data in non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.
- Conditions
- Anxiety and Fear, Pain, Surgery
- Being tested
- Projector Kaleidoscope, Cartoon
- Keywords
- anxiety, fear, pain, day surgery
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Projector KaleidoscopeOther
Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room.
CartoonOther
Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Projector Kaleidoscope | Experimental | Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction into the operating room. Receives: Other: Projector Kaleidoscope |
| Cartoon | Experimental | Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes. Receives: Other: Cartoon |
| Control | No intervention | Routine care will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Child Anxiety Scale-State scale will be used. The scale is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer" or "If you're a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0 and 10
Measured: 1 day
Fear
"Children's Fear Scale" will be used. This Scale includes 5 different facial expressions. This scale is scored between 0-4 and is stated to be a reliable and valid measurement tool in the assessment of fear.
Measured: 1 day
Pain after surgery
The Wong-Baker scale will be used. There are six facial expressions scored from zero to five. The Wong-Baker Scale has faces that indicate increasing pain intensity from zero to five from left to right.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jun 2024
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Anxiety and FearStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339047
- Sponsor's protocol ID
- 2024/09
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbasnia F, Aghebati N, Miri HH, Etezadpour M. Effects of Patient Education and Distraction Approaches Using Virtual Reality on Pre-operative Anxiety and Post-operative Pain in Patients Undergoing Laparoscopic Cholecystectomy. Pain Manag Nurs. 2023 Jun;24(3):280-288. doi: 10.1016/j.pmn.2022.12.006. Epub 2023 Jan 17.
PubMed 36658058Atalay, B., Güler, R., & Haylı, Ç.M.(2021). Investıgatıon of preoperatıve anxıety levels ın pedıatrıc groups. Turkish Journal of Health Science and Life, 4(1), 24-26.
Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.
PubMed 31391620Bartik K, Toruner EK. Effectiveness of a Preoperative Preparation Program on Children's Emotional States and Parental Anxiety. J Perianesth Nurs. 2018 Dec;33(6):972-980. doi: 10.1016/j.jopan.2017.09.008. Epub 2017 Nov 20.
PubMed 30449445Bülbül, F., &Arıkan B. (2018). Çocuklarda ameliyat öncesi psikolojik hazırlık:Güncel Yaklaşımlar. Balıkesır Health Scıences Journal, 7(3), 101-107.
Chartrand J, Tourigny J, MacCormick J. The effect of an educational pre-operative DVD on parents' and children's outcomes after a same-day surgery: a randomized controlled trial. J Adv Nurs. 2017 Mar;73(3):599-611. doi: 10.1111/jan.13161. Epub 2016 Oct 20.
PubMed 27681601Eijlers R, Dierckx B, Staals LM, Berghmans JM, van der Schroeff MP, Strabbing EM, Wijnen RMH, Hillegers MHJ, Legerstee JS, Utens EMWJ. Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):728-737. doi: 10.1097/EJA.0000000000001059.
PubMed 31356373Ersig, A.L.,Kleiber, C., McCarthy, A.M., ve Hanrahan, K. (2013). Validation of a clinicallyusefulmeasure of children'sstateanxietybeforemedicalprocedures. JournalforSpecialists in PediatricNursing, 18(4), 311-319.
Gai N, Naser B, Hanley J, Peliowski A, Hayes J, Aoyama K. A practical guide to acute pain management in children. J Anesth. 2020 Jun;34(3):421-433. doi: 10.1007/s00540-020-02767-x. Epub 2020 Mar 31.
PubMed 32236681Gerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyeteskalası-durumluluk ve çocuk Korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
Liu W, Xu R, Jia J, Shen Y, Li W, Bo L. Research Progress on Risk Factors of Preoperative Anxiety in Children: A Scoping Review. Int J Environ Res Public Health. 2022 Aug 9;19(16):9828. doi: 10.3390/ijerph19169828.
PubMed 36011459McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Tadesse, M., Ahmed, S., Regassa, T., Girma, T., Hailu, S., Mohammed, A., &Mohammed, S. (2022). Effect of preoperativeanxiety on postoperativepain on patientsundergoingelectivesurgery: Prospectivecohortstudy. Annals of MedicineandSurgery, 73, 103190
Stamenkovic DM, Rancic NK, Latas MB, Neskovic V, Rondovic GM, Wu JD, Cattano D. Preoperative anxiety and implications on postoperative recovery: what can we do to change our history. Minerva Anestesiol. 2018 Nov;84(11):1307-1317. doi: 10.23736/S0375-9393.18.12520-X. Epub 2018 Apr 5.
PubMed 29624026Yaz, Ş. B.,&Yilmaz, H. B. (2022). Theeffects of designing an educationalanimationmovie in virtualreality on preoperativefearandpostoperativepain in pediatricpatients: A Randomizedcontrolledtrial. Journal of PeriAnesthesiaNursing,37 (3), 357-364
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Projector Kaleidoscope and Cartoons in the Operating Room on Anxiety, Fear and Pain in Children Aged 4-10 Who Will Undergo Outpatient Surgery
- ClinicalTrials.gov ID
- NCT06339047
- Acronym / sponsor ID
- 2024/09
- Conditions
- Anxiety and Fear, Pain, Surgery
- Keywords
- anxiety, fear, pain, day surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 1 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.
The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.
The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.
In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used.
Detailed description
The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.
The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.
In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale, and Vital Signs Follow-up Form will be used.
Collection of Data The research will be implemented after ethics committee approval and written institutional permission are obtained.
Stage 1: By consulting experts on the subject, the researchers will create a pool of cartoons suitable for the level of children in the 4-10 age group that they can watch. The created children's cartoon pool will be sent to people who are experts in the field (child development specialists, child psychiatrists, and pediatric nurses).
Stage 2: Data collection forms to be used before the research. A pilot study will be conducted with 10 children to evaluate the suitability of the cartoon for children.
Stage 3: The children and their parents in the sample group will be informed about the method followed in the application and the research, and their verbal and written permissions will be obtained.
Stage 4: The introductory information form in the research will be applied to the children in the sample group.
Stage 5: Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria to 3 groups (1st experimental group, 2nd experimental control group and 3rd group control group) through a computer program.
(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). Stage 6: Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room. Children in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes.
Stage 7: Before the surgery, the anxiety, fear and vital signs of the children in the sample will be evaluated. Children's fear assessment will be done by both the child and the nurse. Since parents are not allowed into the operating room, the evaluation will be made only by the child and the nurse.
Stage 8: In the postoperative period, the anxiety, fear, vital signs and pain of the children in the experimental and control groups will be recorded. Children's fear and pain assessment will be done by the child, nurse and parent.
Analysis of Research Data:
The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean, and standard deviation) will be used when evaluating the data. The suitability of the data used for normal distribution will be checked with kurtosis and skewness values. In comparing quantitative data with normally distributed data, an independent t-test will be used for the difference between two independent groups. In comparing more than two dependent groups, analysis of variance will be applied in repeated measurements and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data in non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Projector Kaleidoscope | Experimental | Other: Projector KaleidoscopeChildren in the projector kaleidoscope group will be watched for approximately 5 minutes before induction into the operating room. |
| Cartoon | Experimental | Other: CartoonChildren in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes. |
| Control | No intervention | –Routine care will be given |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being between the ages of 4-10
- Having outpatient surgery
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having had a previous surgical intervention
- Having a chronic disease
- The child has visual, hearing, and mental disabilities
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 |
|---|---|---|
| Projector KaleidoscopeChildren in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room. | Other | Projector Kaleidoscope |
| CartoonChildren in the cartoon group will be asked which cartoon they want to watch from the cartoon pool and will be shown the cartoon they want. The cartoon duration is approximately 5 minutes. | Other | Cartoon |
Primary outcome
Anxiety
Time frame: 1 day
Child Anxiety Scale-State scale will be used. The scale is shaped like a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer" or "If you're a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0 and 10
Fear
Time frame: 1 day
"Children's Fear Scale" will be used. This Scale includes 5 different facial expressions. This scale is scored between 0-4 and is stated to be a reliable and valid measurement tool in the assessment of fear.
Pain after surgery
Time frame: 1 day
The Wong-Baker scale will be used. There are six facial expressions scored from zero to five. The Wong-Baker Scale has faces that indicate increasing pain intensity from zero to five from left to right.
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 20 Nov 2024.
- Background: PubMed 36658058Abbasnia F, Aghebati N, Miri HH, Etezadpour M. Effects of Patient Education and Distraction Approaches Using Virtual Reality on Pre-operative Anxiety and Post-operative Pain in Patients Undergoing Laparoscopic Cholecystectomy. Pain Manag Nurs. 2023 Jun;24(3):280-288. doi: 10.1016/j.pmn.2022.12.006. Epub 2023 Jan 17.
- BackgroundAtalay, B., Güler, R., & Haylı, Ç.M.(2021). Investıgatıon of preoperatıve anxıety levels ın pedıatrıc groups. Turkish Journal of Health Science and Life, 4(1), 24-26.
- Background: PubMed 31391620Baghele A, Dave N, Dias R, Shah H. Effect of preoperative education on anxiety in children undergoing day-care surgery. Indian J Anaesth. 2019 Jul;63(7):565-570. doi: 10.4103/ija.IJA_37_19.
- Background: PubMed 30449445Bartik K, Toruner EK. Effectiveness of a Preoperative Preparation Program on Children's Emotional States and Parental Anxiety. J Perianesth Nurs. 2018 Dec;33(6):972-980. doi: 10.1016/j.jopan.2017.09.008. Epub 2017 Nov 20.
- BackgroundBülbül, F., &Arıkan B. (2018). Çocuklarda ameliyat öncesi psikolojik hazırlık:Güncel Yaklaşımlar. Balıkesır Health Scıences Journal, 7(3), 101-107.
- Background: PubMed 27681601Chartrand J, Tourigny J, MacCormick J. The effect of an educational pre-operative DVD on parents' and children's outcomes after a same-day surgery: a randomized controlled trial. J Adv Nurs. 2017 Mar;73(3):599-611. doi: 10.1111/jan.13161. Epub 2016 Oct 20.
- Background: PubMed 31356373Eijlers R, Dierckx B, Staals LM, Berghmans JM, van der Schroeff MP, Strabbing EM, Wijnen RMH, Hillegers MHJ, Legerstee JS, Utens EMWJ. Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):728-737. doi: 10.1097/EJA.0000000000001059.
- BackgroundErsig, A.L.,Kleiber, C., McCarthy, A.M., ve Hanrahan, K. (2013). Validation of a clinicallyusefulmeasure of children'sstateanxietybeforemedicalprocedures. JournalforSpecialists in PediatricNursing, 18(4), 311-319.
- Background: PubMed 32236681Gai N, Naser B, Hanley J, Peliowski A, Hayes J, Aoyama K. A practical guide to acute pain management in children. J Anesth. 2020 Jun;34(3):421-433. doi: 10.1007/s00540-020-02767-x. Epub 2020 Mar 31.
- BackgroundGerçeker, G. Ö., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyeteskalası-durumluluk ve çocuk Korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.
- Background: PubMed 36011459Liu W, Xu R, Jia J, Shen Y, Li W, Bo L. Research Progress on Risk Factors of Preoperative Anxiety in Children: A Scoping Review. Int J Environ Res Public Health. 2022 Aug 9;19(16):9828. doi: 10.3390/ijerph19169828.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Projector Kaleidoscope and Cartoon in people with Anxiety and Fear and Pain, run by Tarsus 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 3 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 20 Nov 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: 1 day). 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 NCT06339047, which also lists 15 linked publications.
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 20 Nov 2024.