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Active, not recruitingNCT06339866Updated Apr 2, 2024

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

An interventional study of The Effect of Two Different Video Interventions on Pain and Anxiety in Children with Adenotonsillectomy: A Randomized Controlled Study in Pain After Adenotonsillectomy, sponsored by Zonguldak Bulent Ecevit University. Active, not recruiting at 1 site in Turkey. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Jun 2023, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain After Adenotonsillectomy

Keywords

  • pain,adenotonsillectomy,anxiety,children
03

In context

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    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

    Time frame: 6 months

07

Study locations

1 site
  • Mihriye
    Zonguldak, 67600, Turkey
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339866
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
mihriye koca (Master student, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Apr 1, 2024
Start date
Jun 25, 2023
Primary completion
Jun 25, 2024 (estimated)
Completion
Jun 25, 2024 (estimated)
Last update
Apr 2, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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