Active and Passive Distraction Techniques

NCT05242939 | Completed

• 1 other identifier: Inhalation Therapy in Children
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Child, Only; Inhalation Therapy; Complications

Keywords

inhalation therapy; child; fear; cartoon; video game

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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.

  1 year

Secondary Outcomes (4)

• Pulse oximetry

  1 year

• Heartbeat

  1 year

• Respiratory

  1 year

• Spo2

  1 year

Study Arms (3)

The Group of Cartoons

EXPERIMENTAL

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 Group of Game

EXPERIMENTAL

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

Rutin Care Group

NO INTERVENTION

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.

Interventions

Video game OTHER

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.

The Group of Game

Watching cartoons OTHER

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.

The Group of Cartoons

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Kepez, Antalya, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 32289071 BACKGROUND

• 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.

  PMID: 20338620 BACKGROUND

• 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.

  PMID: 21859275 BACKGROUND

• 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.

  PMID: 27112434 BACKGROUND

• Fernandes SC, Arriaga P. The effects of clown intervention on worries and emotional responses in children undergoing surgery. J Health Psychol. 2010 Apr;15(3):405-15. doi: 10.1177/1359105309350231.

  PMID: 20348361 BACKGROUND

• DiBlasi RM. Clinical Controversies in Aerosol Therapy for Infants and Children. Respir Care. 2015 Jun;60(6):894-914; discussion 914-6. doi: 10.4187/respcare.04137.

  PMID: 26070582 BACKGROUND

• Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.

  PMID: 33742204 BACKGROUND

• Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.

  PMID: 24094126 BACKGROUND

• Tufekci FG, Celebioglu A, Kucukoglu S. Turkish children loved distraction: using kaleidoscope to reduce perceived pain during venipuncture. J Clin Nurs. 2009 Aug;18(15):2180-6. doi: 10.1111/j.1365-2702.2008.02775.x.

  PMID: 19583650 BACKGROUND

• Kwok PC, Chan HK. Delivery of inhalation drugs to children for asthma and other respiratory diseases. Adv Drug Deliv Rev. 2014 Jun;73:83-8. doi: 10.1016/j.addr.2013.11.007. Epub 2013 Nov 21.

  PMID: 24270011 BACKGROUND

• Mutlu B, Balci S. Effects of balloon inflation and cough trick methods on easing pain in children during the drawing of venous blood samples: a randomized controlled trial. J Spec Pediatr Nurs. 2015 Jul;20(3):178-86. doi: 10.1111/jspn.12112. Epub 2015 Mar 28.

  PMID: 25817062 BACKGROUND

• Risaw L, Narang K, Thakur JS, Ghai S, Kaur S, Bharti B. Efficacy of Flippits to Reduce Pain in Children during Venipuncture - A Randomized Controlled Trial. Indian J Pediatr. 2017 Aug;84(8):597-600. doi: 10.1007/s12098-017-2335-z. Epub 2017 Apr 5.

  PMID: 28378139 BACKGROUND

• Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

  PMID: 30362982 RESULT

Related Links

• Effectiveness Of '' Animated Cartoons '' As A Distraction Strategy On Behavior Response To Pain Perception Among Children Undergoing. Venipuncture
• The Effect of Distraction Technique on the Pain of Dressing Change among 3-6 Year-old Children
• Durumluk-sürekli kaygı envanteri el kitabı
• Effects of Distraction on Physiologic Indices and Pain Intensity in children aged 3-6 Undergoing IV Injection
• Primary out come

Study Officials

• Uğur Gül

  Akdeniz Univercity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 16, 2022
• Study Start: December 30, 2021
• Primary Completion: February 19, 2022
• Study Completion: April 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)