Active and Passive Distraction Techniques

July 18, 2022 updated by: Uğur Gül, Akdeniz University

Comparison of Active and Passive Distraction Techniques in Reducing Anxiety and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

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
    • Antalya
      • Kepez, Antalya, Turkey
        • Akdeniz University

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

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Group of Cartoons
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.
Other: Watching cartoons
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.
Experimental: The Group of Game
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.
Other: Video game
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.
No Intervention: Rutin Care Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Fear Scale (CFS) Measure
Time Frame: 1 year

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
1 year
Child Anxiety Scale-State (CAS-S)
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse oximetry
Time Frame: 1 year
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
1 year
Heartbeat
Time Frame: 1 year

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
1 year
Respiratory
Time Frame: 1 year
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
1 year
Spo2
Time Frame: 1 year
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
1 year

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Uğur Gül, Akdeniz Univercity

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.

General Publications

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)

December 30, 2021

Primary Completion (Actual)

February 19, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inhalation Therapy in Children

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

product manufactured in and exported from the U.S.

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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