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Active and Passive Distraction Techniques

Primary Purpose

Child, Only, Inhalation Therapy; Complications

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video game
Watching cartoons
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child, Only focused on measuring inhalation therapy, child, fear, cartoon, video game

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children aged 4-7 years
  2. Children who have not undergone any painful procedures before the procedure
  3. Parents with smartphones
  4. Children and parents who can speak and understand Turkish
  5. Children of parents who agreed to participate in the study and whose written consent form was obtained from them will be included in the study.

Exclusion Criteria:

  1. Having a neurological disorder,
  2. Congenital anomaly,
  3. Growth and development retardation,
  4. Hearing impaired,
  5. Having visual impairment,
  6. Having a chronic disease,
  7. Using anti-epileptic drugs in the last 6 hours,
  8. Children with suspected COVID-19 will not be included in the study.

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

The Group of Cartoons

The Group of Game

Rutin Care Group

Arm Description

The cartoons that are suitable for the child's age and gender will be watched. The child will be asked which cartoon he would like to watch. The cartoon is 5 min from the application. It will be started to be watched first and will continue until the application is finished. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher. Due to the COVID-19 pandemic, cartoons will be watched on the parent's phone. Parents who do not have an internet connection will also be provided with internet access by the researcher. The child will watch cartoons on their parent's phone.

723 / 5.000 Çeviri sonuçları The group whose video games will be played will be told to choose the game they want before the process. Due to the COVID-19 pandemic, video games will be played on the parent's phone. Parents who do not have an internet connection will also be provided with internet access by the researcher. The child will play the video game on their parent's phone.

In the control group, the institution's routine nebula application will be performed and no intervention will be made. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher.

Outcomes

Primary Outcome Measures

Child Fear Scale (CFS) Measure
The Child Fear Scale is aimed at children between the ages of 4-10 and was used to evaluate the anxiety in children before and during the procedure. The CLS, which was translated into Turkish by Gerceker et al. (2018) and whose validity and reliability studies were conducted in Turkish, was developed by McKinley et al. The mean score of the CLS, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). CLS can also be scored by parents and researchers. The CLS consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety). The Child Fear Scale score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Child Anxiety Scale-State (CAS-S)
The Child Anxiety Scale-Status (CAS-S) scale, developed by Ersig et al. to measure the anxiety levels of children aged 4-10. Validity and reliability study was conducted for children aged 10 years, and the validity index was found to be 1.00 for the Child Anxiety Scale-State Scale.The ÇAS-S scale is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. On this scale for 4-10 year olds, children may say, "Imagine all your anxious or angry feelings are on the bulb or the bottom of the thermometer" or "If you're a little worried or nervous, emotions may run a little higher on the thermometer. If you are very, very anxious or nervous, the emotions can run high. Put a line on the thermometer to show how worried or angry you are." In order to measure state anxiety (CAS-S), the child is asked to mark what he feels "at the moment". The score can vary between 0 - 10.

Secondary Outcome Measures

Pulse oximetry
Pulse oximetry is a portable monitor that displays peak heart rate and oxygen saturation values together. Heartbeat will be checked with the Nellcor device attached to the baby's right index finger. Pulse oximetry score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Heartbeat
Heartbeat will be checked with the Nellcor device attached to the baby's right index finger. Heratbeat score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Respiratory
Participant's respiration will be measured by the researcher. Respiratory score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Spo2
Spo2 will be checked with the Nellcor device attached to the baby's right index. Spo2 score will be recorded five minutes before the intervention, during intervention and five minutes after intervention

Full Information

First Posted
December 28, 2021
Last Updated
July 18, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05242939
Brief Title
Active and Passive Distraction Techniques
Official Title
Comparison of Active and Passive Distraction Techniques in Reducing Anxiety and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Treatment methods with nebulizers are used in the treatment of many diseases such as asthma, bronchitis, bronchiolitis and cystic fibrosis in children. Because inhalation therapy with a face mask is scary for children, it can be difficult to provide this therapy effectively and safely. Adaptation of the child and family is important for the success of inhalation therapy. Distraction techniques are among the most commonly used cognitive/behavioral methods. It determines the effect of "playing video games" and "watching cartoons" methods, which are active distraction methods during inhalation therapy, on the level of fear and anxiety.
Detailed Description
Hospitalization can be a threatening and stressful experience for children. Unfamiliar with the environment and medical procedures and unaware of the reasons for hospitalization can result in children's anger, uncertainty, anxiety and feelings of helplessness. Anxiety and fear are the most frequently reported among these negative reactions. In addition, high levels of anxiety and fear can be harmful to children's physiological and psychological health. Excessive anxiety and fear also inhibit children's effectiveness in coping with medical treatment and increase their negative emotions. It is thought that the levels of anxiety and fear in children will increase even more when they apply to the emergency services, especially in acute situations. Children who present to the emergency department with respiratory distress and cough can be given inhalation therapy as a result of physical examination and other tests. Today, inhalation therapy with a nebulizer is one of the most common and frequently used methods. Treatment methods with nebulizers are used in the treatment of many diseases such as asthma, bronchitis, bronchiolitis and cystic fibrosis in children. Because inhalation therapy with a face mask is scary for children, it can be difficult to provide this therapy effectively and safely. Adaptation of the child and family is important for the success of inhalation therapy. Evidence-based distraction methods can be used to provide effective inhalation and reduce fear of children. Recent research has focused on the use of non-pharmacological methods in the management of pain in children. Non-pharmacological methods used to manage pain and anxiety in children fall into three main groups; supportive methods, cognitive/behavioral methods, and physical methods. Distraction techniques are among the most commonly used cognitive/behavioral methods. It has been reported that distraction cards, watching cartoons, using kaleidoscope, and listening to music reduce pain, anxiety and fear levels. It is noteworthy that similar studies mostly focused on invasive applications. On the other hand, it is stated that studies on the effect of non-pharmacological methods in inhalation therapy, which is one of the common non-invasive procedures in children, are still limited. Another aim of this study is; This study determines the effect of "playing video games" and "watching cartoons" methods, which are active distraction methods during inhalation therapy, on the level of fear and anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Only, Inhalation Therapy; Complications
Keywords
inhalation therapy, child, fear, cartoon, video game

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Group of Cartoons
Arm Type
Experimental
Arm Description
The cartoons that are suitable for the child's age and gender will be watched. The child will be asked which cartoon he would like to watch. The cartoon is 5 min from the application. It will be started to be watched first and will continue until the application is finished. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher. Due to the COVID-19 pandemic, cartoons will be watched on the parent's phone. Parents who do not have an internet connection will also be provided with internet access by the researcher. The child will watch cartoons on their parent's phone.
Arm Title
The Group of Game
Arm Type
Experimental
Arm Description
723 / 5.000 Çeviri sonuçları The group whose video games will be played will be told to choose the game they want before the process. Due to the COVID-19 pandemic, video games will be played on the parent's phone. Parents who do not have an internet connection will also be provided with internet access by the researcher. The child will play the video game on their parent's phone.
Arm Title
Rutin Care Group
Arm Type
No Intervention
Arm Description
In the control group, the institution's routine nebula application will be performed and no intervention will be made. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher.
Intervention Type
Other
Intervention Name(s)
Video game
Intervention Description
The child will be allowed to play the game they want to play throughout the entire procedure, starting 5 minutes before the inhalation therapy. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher.
Intervention Type
Other
Intervention Name(s)
Watching cartoons
Intervention Description
The cartoon is 5 min from the application. It will be started to be watched first and will continue until the application is finished. Vital signs (pulse, respiration and SPo2), Child Fear Scale and Child Anxiety Scale-State Statement Scale (CAS-D) will be evaluated by the researcher and the child before, immediately and 5 minutes after the application and recorded in the intervention follow-up form by the researcher.
Primary Outcome Measure Information:
Title
Child Fear Scale (CFS) Measure
Description
The Child Fear Scale is aimed at children between the ages of 4-10 and was used to evaluate the anxiety in children before and during the procedure. The CLS, which was translated into Turkish by Gerceker et al. (2018) and whose validity and reliability studies were conducted in Turkish, was developed by McKinley et al. The mean score of the CLS, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). CLS can also be scored by parents and researchers. The CLS consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety). The Child Fear Scale score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Time Frame
1 year
Title
Child Anxiety Scale-State (CAS-S)
Description
The Child Anxiety Scale-Status (CAS-S) scale, developed by Ersig et al. to measure the anxiety levels of children aged 4-10. Validity and reliability study was conducted for children aged 10 years, and the validity index was found to be 1.00 for the Child Anxiety Scale-State Scale.The ÇAS-S scale is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. On this scale for 4-10 year olds, children may say, "Imagine all your anxious or angry feelings are on the bulb or the bottom of the thermometer" or "If you're a little worried or nervous, emotions may run a little higher on the thermometer. If you are very, very anxious or nervous, the emotions can run high. Put a line on the thermometer to show how worried or angry you are." In order to measure state anxiety (CAS-S), the child is asked to mark what he feels "at the moment". The score can vary between 0 - 10.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pulse oximetry
Description
Pulse oximetry is a portable monitor that displays peak heart rate and oxygen saturation values together. Heartbeat will be checked with the Nellcor device attached to the baby's right index finger. Pulse oximetry score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Time Frame
1 year
Title
Heartbeat
Description
Heartbeat will be checked with the Nellcor device attached to the baby's right index finger. Heratbeat score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Time Frame
1 year
Title
Respiratory
Description
Participant's respiration will be measured by the researcher. Respiratory score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Time Frame
1 year
Title
Spo2
Description
Spo2 will be checked with the Nellcor device attached to the baby's right index. Spo2 score will be recorded five minutes before the intervention, during intervention and five minutes after intervention
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 4-7 years Children who have not undergone any painful procedures before the procedure Parents with smartphones Children and parents who can speak and understand Turkish Children of parents who agreed to participate in the study and whose written consent form was obtained from them will be included in the study. Exclusion Criteria: Having a neurological disorder, Congenital anomaly, Growth and development retardation, Hearing impaired, Having visual impairment, Having a chronic disease, Using anti-epileptic drugs in the last 6 hours, Children with suspected COVID-19 will not be included in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uğur Gül
Organizational Affiliation
Akdeniz Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Kepez
State/Province
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32289071
Citation
Alhaider SA, Alshehri HA, Al-Eid K. Replacing nebulizers by MDI-spacers for bronchodilator and inhaled corticosteroid administration: Impact on the utilization of hospital resources. Int J Pediatr Adolesc Med. 2014 Sep;1(1):26-30. doi: 10.1016/j.ijpam.2014.09.002. Epub 2014 Oct 22.
Results Reference
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20338620
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Amirav I, Newhouse MT, Minocchieri S, Castro-Rodriguez JA, Schuepp KG. Factors that affect the efficacy of inhaled corticosteroids for infants and young children. J Allergy Clin Immunol. 2010 Jun;125(6):1206-11. doi: 10.1016/j.jaci.2010.01.034. Epub 2010 Mar 24.
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21859275
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Ari A, Fink JB. Guidelines for aerosol devices in infants, children and adults: which to choose, why and how to achieve effective aerosol therapy. Expert Rev Respir Med. 2011 Aug;5(4):561-72. doi: 10.1586/ers.11.49.
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PubMed Identifier
27112434
Citation
Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
result
Links:
URL
https://nrfninechd.com/effectiveness-of-animated-cartoons-as-a-distraction-strategy-on-behavior-response-to-pain-perception-among-children-undergoing-venipuncture/
Description
Effectiveness Of '' Animated Cartoons '' As A Distraction Strategy On Behavior Response To Pain Perception Among Children Undergoing. Venipuncture
URL
https://ijp.mums.ac.ir/article_6699_54b321fedd9302a43ce53253b6115a47.pdf
Description
The Effect of Distraction Technique on the Pain of Dressing Change among 3-6 Year-old Children
URL
https://eds.p.ebscohost.com/eds/pdfviewer/pdfviewer?vid=0&sid=66b76973-d10b-4e04-9fd8-5b00941ee69a%40redis
Description
Effects of Distraction on Physiologic Indices and Pain Intensity in children aged 3-6 Undergoing IV Injection
URL
https://dergipark.org.tr/tr/download/article-file/752838
Description
Primary out come

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Active and Passive Distraction Techniques

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