Designing Animated Movie for Preoperative Period

NCT04176822 | Completed

• 2 other identifiers: SYazEge
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery. Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.

Conditions

Postoperative Pain; Fear; Surgery; Pain; Nursing Caries; Nurse's Role; Clinical Anxiety; Patient; Pediatric

Keywords

pediatric surgery; preoperative preparation; animation; fear; pain; nursing

Outcome Measures

Primary Outcomes (2)

• Change of Children's Preoperative Fear

  "Children's Fear Scale" (CFS) was developed and adapted by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale, graded between 0 and 4, ("0" is none fear, "4" is maximum fear) is a reliable and valid measurement tool for assessing fear. It includes measuring and evaluating preoperative fears of children.

  15 minutes (2 measurements are made-before and after intervention)

• Change of Children's Postopeartive Pain

  "Wong-Baker FACES Pain Rating Scale" This scale includes six different facial expressions and is scored between 0 and 10 ("0" is none pain, "10" is maximum pain). It is a reliable and valid measurement tool for acute pain assessment, and it does not require words or numeric value. It includes measuring and evaluating postoperative pains of children.

  15 minutes (2 measurements are made-immediately after surgery and 1 hour after surgery) = total 90 minutes

Study Arms (3)

Educational Animated Movie Group

EXPERIMENTAL

All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched an educational animated movie through VR Goggles. The educational animated movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.

Other: Educational animated movie group

Documentary Movie Group

EXPERIMENTAL

All of the children's and parents' written and verbal informed consent were obtained before the study. Parents who did not want to participate in the study were assured that this would not have any adverse effect on their child's treatment. In the morning of surgery, the researcher administered the "Child and Family Identification Data Form" to the parents of children who had the following parameters. Later, both the child and the parents were asked to complete the "Children's Fear Scale". Children included in the study groups with randomization watched a documentary movie through VR Goggles. The documentary movie lasted around 3-4 minutes each. After watching the movie, children and parents were asked to complete the Children's Fear Scale again. Children, parents, and nurses were asked to grade the pain of the child with Wong-Baker FACES Pain Rating Scale when the children returned to their room and after 1 hour in the postoperative period.

Other: Documentary movie group

Control Group

NO INTERVENTION

No intervention was made, pain and fear levels were measured using scales only.

Interventions

Educational animated movie group OTHER

Watching educational animation movie which were designed by the researcher before operation for fear and pain.

Educational Animated Movie Group

Documentary movie group OTHER

Watching documentary movie about trees before operation for fear and pain.

Documentary Movie Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• First surgery
• Daily surgery and uncomplicated surgery
• Agree to participate in the study
• Speaking Turkish

You may not qualify if:

• Refusal to participate in the study
• A genetic/congenital disease
• A chronic disease
• Second or more surgery
• Not speaking Turkish

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, PhD

Model Details: There are 3 independent working groups.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 25, 2019
• Study Start: September 4, 2017
• Primary Completion: September 28, 2018
• Study Completion: March 12, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)