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

NCT ID: NCT05619991

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-08-22

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.

Detailed Description

In this study, 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. It will be conducted in a single center, parallel group, randomized controlled experimental design. Randomization will be provided by randomly and evenly distributing the patients who meet the sample selection criteria into 3 groups (1st experimental group, 2nd experimental group and 3rd group control group) through a program in the computer environment. (http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). The application will be started after the approval of the ethics committee and the written permission of the institution for the research.

Stage 1: The information content to be included in the video will be determined by the researchers, taking the opinions of the experts on the subject, appropriate for the level of the child in the 7-12 age group, for daily surgical intervention (about preparation for surgery, the operating room environment and the post-operative process), and video content will be created. .

Stage 2: In line with the suggestions from researchers and experts, an informative video will be prepared for day surgery (preparation for surgery, operating room environment and the post-operative process) appropriate for the level of the child in the 7-12 age group.

Stage 3: A pilot study will be conducted with 10 children in order to evaluate the data collection forms to be used before the research and the suitability of video education for children.

Stage 4: The children in the sample group and their parents will be informed about the method followed in practice and the research, and verbal and written consent will be obtained.

Stage 5: The introductory information form in the research will be applied to the children in the sample group.

Stage 6: Patients who meet the sample selection criteria will be randomly and equally distributed into 2 groups (1st experimental group, 2nd experimental control group and 3rd group control group) through a program in the computer environment, and randomization will be achieved.

(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html). Stage 7: The children in the experimental group will be shown an informative video prepared.

Stage 8: Before the operation, the fear and vital signs of the children in the sample will be evaluated.

Stage 9: In the postoperative period, pain, fear, vital signs of the children in the experimental and control groups will be recorded and a questionnaire examining the satisfaction status will be applied.

Written approval from Mersin University Clinical Research Ethics Committee, written institutional permission from Tarsus State Hospital, and informed written consent from parents and children will be obtained before the research data begins to be collected. The population of the research will be children between the ages of 7-12 who will undergo outpatient surgery in Tarsus State Hospital, and the sample will be 90 children who meet the criteria for inclusion in the research. Randomization was made between the control and treatment groups by stratification in terms of children, gender and age variables. According to this randomization method, homogeneity is achieved between the groups (Kanik, Taşdelen, & Erdoǧan, 2011). The sample of the research was determined by G power power analysis by consulting a statistician. In the study, power analysis was performed to determine the number of people to work in two groups. The power of the test was calculated with the G*Power 3.1 program. For the power of the work to exceed 80%; 5% significance level and 0.80 effect level; It is necessary to reach a total of 78 people, with a minimum of 26 people in the groups (t=2009; Effect size d=0.80). 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.

Conditions

Day Surgery; Fear; Pain; Satisfaction; CHİLDREN

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group watching video

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.

Group Type: EXPERIMENTAL

Group watching video

Intervention Type: OTHER

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

Scheduled training group

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.

Group Type: OTHER

Scheduled training group

Intervention Type: OTHER

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group watching video

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

Intervention Type: OTHER

Scheduled training group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarsus University

OTHER

Sponsor Role: lead

Responsible Party

Gamze BOZKUL

Research asistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atiye Karakul, Assoc. Prof.

Role: STUDY_DIRECTOR

Tarsus University

Duygu Sönmez Düzkaya, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tarsus University

Şahika Dilşen, Uzm. Dr.

Role: PRINCIPAL_INVESTIGATOR

TARSUS STATE HOSPİTAL

Gamze Bozkul, Res. Ass.

Role: PRINCIPAL_INVESTIGATOR

Tarsus University

Locations

Gamze Bozkul

Mersin, , Turkey (Türkiye)

Tarsus University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30449445 (View on PubMed)

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.

Reference Type: 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.

Reference Type: RESULT

PMID: 31391620 (View on PubMed)

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

Reference Type: RESULT

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

Reference Type: 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.

Reference Type: RESULT

PMID: 27681601 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31356373 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33364873 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27305179 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 35177320 (View on PubMed)

Other Identifiers

TU-BOZKUL-001

Identifier Type: -

Identifier Source: org_study_id