Effect of Short Film Video and Video-Based Education on Fear, Pain, and Satisfaction of Children Undergoing Day Surgery

NCT05619991 | Completed

• 1 other identifier: TU-BOZKUL-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

It is aimed to investigate the effect of introducing the operating room environment with an informative video to pediatric patients aged 7-12 in the preoperative period in day surgery on pain, fear, and patient and parent satisfaction. In line with this purpose, an answer was sought to the question "How did the different education programs given to children who will undergo day surgery have an effect on fear, pain and satisfaction?" It will be conducted in a single center, parallel group, randomized controlled experimental design. The research will be carried out between December 2022 and October 2023 and it is planned to continue for 12 months. The population of the research will be children between the ages of 7-12 who will undergo a day surgery at Tarsus State Hospital, and the sample will be 90 children who meet the criteria for inclusion in the research. Considering that there may be case losses, a total of 90 children (1st experimental group \[watched video training\]:30 children, 2nd experimental group \[provided planned training\]: 30 children, control group: 30 children) will be included in the sample group. In the collection of research data; Introductory Information Form, Numerical Pain Scale, Child Fear Scale, Vital Signs Follow-up Form (Appendix 4) will be used. The application will be started after the approval of the ethics committee and the written permission of the institution for the research. Statistical package program (SPSS 20) will be used in the analysis of the research data.

Conditions

Day Surgery; Fear; Pain; Satisfaction; CHİLDREN

Outcome Measures

Primary Outcomes (5)

• Introductory Information Form

  Introductory Information Form, which was created by the researcher in line with the knowledge of the literature, consists of questions about the child's age, gender, educational status, and characteristics of the procedure (Baghele et al., 2019; Eijlers et al., 2019; Yaz \& Yılmaz, 2021).

  1 day

• Child Fear Scale

  Child Fear Scale, McKinley et al. (2003) as "The Faces Anxiety Scale" for adult patients. The same scale was adapted for pediatric patients as "Children's Fear Scale" by McMurtry et al. (2011). This Scale includes 5 different facial expressions. This scale is scored between 0 and 4, and it is stated to be a reliable and valid measurement tool in the evaluation of fear.

  1 day

• Numerical Pain Scale

  Numerical Pain Scale, this method for determining the severity of pain, aims to explain the patient's pain in numbers. Absence of pain (0) is evaluated as unbearable pain (10) on numerical scales.

  1 day

• The Vital Signs Follow-up Form

  The Vital Signs Follow-up Form was prepared to record the vital signs of children measured before and immediately after the procedure, such as heart rate, blood pressure, saturation value and respiration.

  1 day

• The Child Satisfaction Scale

  The Child Satisfaction Scale was developed by researchers in a way that children can easily understand (Çelik, 2020). The numbers between 0 and 10, which the children would indicate by circling the point corresponding to their satisfaction with the education provided, were placed on a horizontal line. On the scale, 0 points means "not at all satisfied" and 10 points means "extremely satisfied". In addition, images reflecting the degree of satisfaction have been added to the places where the scores are located. In the study, it is planned to be applied to all groups after surgery.

  1 day

Study Arms (3)

Group watching video

EXPERIMENTAL

For the Educational Video, a scenario appropriate for the age group, about the preparation for the surgery, the operating room environment and the post-operative process will be created by the researchers. Expert opinion will be taken for the suitability of the scenario.

Other: Group watching video

Scheduled training group

OTHER

For the Planned Education, a power point presentation will be prepared by the researchers, appropriate for the age group, about the preparation for the surgery, the operating room environment and the post-operative process, and the patients will be trained before the surgery.

Other: Scheduled training group

Control group

NO INTERVENTION

Before the operation, the fear and vital signs of the children in the sample will be evaluated. In the postoperative period, the pain, fear and vital signs of the children in the control group will be recorded and a questionnaire examining the satisfaction status will be applied.

Interventions

Group watching video OTHER

The video will include preparation for the surgery, the operating room environment and the post-operative process.

Group watching video

Scheduled training group OTHER

The scheduled training will include preparation for the surgery, the operating room environment and the post-operative process.

Scheduled training group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To be 7 and 12 years old
• Having day surgery
• Not having undergone previous surgery
• Not have a chronic disease
• No communication, mental or neurological problems
• Volunteering to participate in the study

You may not qualify if:

• Not be in the 7-12 age range
• Not to have day surgery
• Having had previous surgery
• have a chronic illness
• Having another chronic illness
• Have a communication, mental, or neurological problem
• Not willing to participate in the study

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (2)

Gamze Bozkul

Mersin, 33400, Turkey (Türkiye)

Location

Tarsus University

Mersin, Turkey (Türkiye)

Location

Related Publications (11)

• 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: 30449445 BACKGROUND

• 1. Atalay B, Güler R.,Haylı Ç.M.(2021). Investıgatıon Of Preoperatıve Anxıety Levels In Pedıatrıc Groups. Turkish Journal of Health Science and Life, 4(1); 24-26.

  RESULT

• 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: 31391620 RESULT

• 4. Bülbül, F., &Arıkan B. (2018).Çocuklarda ameliyat öncesi psikolojik hazırlık:Güncel Yaklaşımlar. Balikesir Saglik Bil Derg 7(3).

  RESULT

• 5. Çelik S. (2020). Pediatrik triyajda palyaço uygulamasinin çocukebeveynin anksiyete ve memnuniyetine etkisi. İstanbul Üniversitesi-Cerrahpaşa Lisansüstü Eğitim Enstitüsü, Doktora tezi, 2021.

  RESULT

• 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: 27681601 RESULT

• 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: 31356373 RESULT

• Getahun AB, Endalew NS, Mersha AT, Admass BA. Magnitude and Factors Associated with Preoperative Anxiety Among Pediatric Patients: Cross-Sectional Study. Pediatric Health Med Ther. 2020 Dec 16;11:485-494. doi: 10.2147/PHMT.S288077. eCollection 2020.

  PMID: 33364873 RESULT

• Moura LA, Dias IM, Pereira LV. Prevalence and factors associated with preoperative anxiety in children aged 5-12 years. Rev Lat Am Enfermagem. 2016 Jun 14;24:e2708. doi: 10.1590/1518-8345.0723.2708.

  PMID: 27305179 RESULT

• 10. Okyay R.D.,Ayoğlu H.(2018). Çocuklarda Postoperatif Ağrı Yönetimi. Pediatr Pract Res; 6(2):16-25.

  RESULT

• Binay Yaz S, Bal Yilmaz H. The Effects of Designing an Educational Animation Movie in Virtual Reality on Preoperative Fear and Postoperative Pain in Pediatric Patients: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):357-364. doi: 10.1016/j.jopan.2021.04.015. Epub 2022 Feb 15.

  PMID: 35177320 RESULT

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Atiye Karakul, Assoc. Prof.

  Tarsus University

  STUDY DIRECTOR

• Duygu Sönmez Düzkaya, Assoc. Prof.

  Tarsus University

  PRINCIPAL INVESTIGATOR

• Şahika Dilşen, Uzm. Dr.

  TARSUS STATE HOSPİTAL

  PRINCIPAL INVESTIGATOR

• Gamze Bozkul, Res. Ass.

  Tarsus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research asistant

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: April 10, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 22, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)