The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy

March 30, 2024 updated by: mihriye koca, Zonguldak Bulent Ecevit University

Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy: A Randomized Controlled Study

Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.

Type of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Technology is an indispensable part of our age and daily life . When we look at the research, it is seen that educational interventional preparation programs increase the harmony between both children, parents and health professionals. The increase in children's self-control and the elimination of unrealistic expectations may be related to the trust in healthcare professionals. Studies indicate that educational video animations are the most effective non-pharmacological method in reducing anxiety . Video animations will be useful for children because they create sound and images. It is believed that video animations with educational content that are understandable to children are essential for children's education. It is believed that animation shown to children will reduce their anxiety.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Zonguldak, Turkey, 67600
        • Mihriye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between the ages of 6-12
  • Having adenotonsillectomy surgery
  • Signing the informed consent form by the patient's legal guardian

Exclusion Criteria:

  • Not being between the ages of 6-12
  • Not having adenotonsillectomy surgery
  • Failure to sign the enformel consent form by the patient's legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group will follow the routine plan of the ward without any intervention planned.
Experimental: Educational animation group
After the patients in this group arrive at the ward (after adenotonsillectomy), the Wong Baker pain scale and Child Anxiety Scale-Status (CAS-D) will be filled out by three observers (clinic nurse, parent and child) before the educational animated movie (before analgesic application) containing the surgical process at the 3rd hour (after adenotonsillectomy) and the animation will be watched behind it, and at the end, the same scales will be filled out again by three observers and the patient's pain and anxiety level will be evaluated.
Other: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study
The population of the study will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria.
Experimental: Cartoon series group
In this group, the Wong Baker pain scale and Child Anxiety Scale-Disposition (CAS-D) will be filled out by three observers before watching cartoons at the 3rd hour post op (before analgesic administration), and the scales will be filled out again after the cartoon and anxiety and pain levels will be evaluated.
Other: The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study
The population of the study will be all patients who had adenotonsillectomy surgery between the ages of 6-12 in the Ear Nose and Throat Service of Zonguldak Bülent Ecevit University Hospital, and the sample will be all patients who had adenotonsillectomy surgery between the specified dates and who meet the inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
After the intervention, the mean score of the children in the postoperative animation and cartoon group on the Wong Baker Pain Rating Scale will be lower than those in the control group.
Time Frame: 6 months
The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst." As the score increases, the child's pain improves.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
After the intervention, the mean score of the Children's Anxiety Scale-Stability score of the children in the postoperative animation and cartoon group will be less than those in the control group.
Time Frame: 6 months
The CASS is configured as a thermometer, including a bulb chamber at the bottom and horizontal lines upwards. Each horizontal line represents one score and the thermometer has 10 points. The bulb chamber at the bottom has 0 points and indicates no anxiety. As horizontal lines rise upwards, it is interpreted as an increase in anxiety. The highest score is 10, referring to the highest anxiety
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2023

Primary Completion (Estimated)

June 25, 2024

Study Completion (Estimated)

June 25, 2024

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

March 24, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E16734702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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