NCT06339047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

March 24, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

anxietyfearpainday surgery

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    1 day

Study Arms (3)

Projector Kaleidoscope

EXPERIMENTAL

Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction into the operating room.

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.

Other: Cartoon

Control

NO INTERVENTION

Routine care will be given

Interventions

Children in the projector kaleidoscope group will be watched for approximately 5 minutes before induction in the operating room.

Projector Kaleidoscope
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.

Cartoon

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (15)

  • 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.

    PMID: 36658058BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31391620BACKGROUND
  • 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.

    PMID: 30449445BACKGROUND
  • Bülbül, F., &Arıkan B. (2018). Çocuklarda ameliyat öncesi psikolojik hazırlık:Güncel Yaklaşımlar. Balıkesır Health Scıences Journal, 7(3), 101-107.

    BACKGROUND
  • 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.

    PMID: 27681601BACKGROUND
  • 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.

    PMID: 31356373BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32236681BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 36011459BACKGROUND
  • 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.

    PMID: 21806301BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29624026BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 1, 2024

Study Start

June 1, 2024

Primary Completion

November 19, 2024

Study Completion

November 19, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations