Clinical trial NCT06339047: The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Fear
Pain
Surgery
Keywords: anxiety
fear
pain
day surgery
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled experimental study
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 4-10
* Having outpatient surgery
* Volunteering to participate in the study

Exclusion Criteria:

* Having had a previous surgical intervention
* Having a chronic disease
* The child has visual, hearing, and mental disabilities

Primary outcomes:
measure: Anxiety
timeFrame: 1 day
measure: Fear
timeFrame: 1 day
measure: Pain after surgery
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus State Hospital
Study officials:
References:
citation: 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.
citation: Atalay, 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.
citation: 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.
citation: Bartik 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.
citation: Bülbül, F., &Arıkan B. (2018). Çocuklarda ameliyat öncesi psikolojik hazırlık:Güncel Yaklaşımlar. Balıkesır Health Scıences Journal, 7(3), 101-107.
citation: 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.
citation: Eijlers 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.
citation: Ersig, 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.
citation: 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.
citation: Gerçeker, 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.
citation: 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.
citation: McMurtry 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.
citation: Tadesse, 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
citation: 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.
citation: Yaz, 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