Clinical trial NCT05619991: Effect of Short Film Video and Video-Based Education on Fear, Pain, and Satisfaction of Children Undergoing Day Surgery
Official title: Effect of Short Film Video and Video-Based Education on Fear, Pain, and Satisfaction of Children Undergoing Day Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Day Surgery
Fear
Pain
Satisfaction
CHİLDREN
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, \&amp; 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.

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

Primary outcomes:
measure: Introductory Information Form
timeFrame: 1 day
measure: Child Fear Scale
timeFrame: 1 day
measure: Numerical Pain Scale
timeFrame: 1 day
measure: The Vital Signs Follow-up Form
timeFrame: 1 day
measure: The Child Satisfaction Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Gamze Bozkul
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
affiliation: Tarsus University
name: Atiye Karakul, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Tarsus University
name: Duygu Sönmez Düzkaya, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: TARSUS STATE HOSPİTAL
name: Şahika Dilşen, Uzm. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarsus University
name: Gamze Bozkul, Res. Ass.
role: PRINCIPAL_INVESTIGATOR
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