Child, OnlyNCT05242939
Active and Passive Distraction Techniques
A study testing Video game and Watching cartoons in people with Child, Only and Inhalation Therapy; Complications, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Inhalation Therapy; Complications
- What is being tested?
- Video game and Watching cartoons
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child, Only, Inhalation Therapy; Complications
- Being tested
- Video game, Watching cartoons
- Keywords
- inhalation therapy, child, fear, cartoon, video game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gameOther
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.
Watching cartoonsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start30 Dec 2021
- Primary completion19 Feb 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur Gül, Akdeniz University
- Investigators
- Uğur Gül, Principal investigator, Akdeniz Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242939
- Sponsor's protocol ID
- Inhalation Therapy in Children
- Status last verified
- Jul 2022
- First submitted
- 28 Dec 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32289071Amirav 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.
PubMed 20338620Ari 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.
PubMed 21859275Aydin 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.
PubMed 27112434Fernandes 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.
PubMed 20348361DiBlasi 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.
PubMed 26070582Durak 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.
PubMed 33742204Ersig 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.
PubMed 24094126Tufekci 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.
PubMed 19583650Kwok 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.
PubMed 24270011Mutlu 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.
PubMed 25817062Risaw 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.
PubMed 28378139Inan 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.
PubMed 30362982
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active and Passive Distraction Techniques in Reducing Anxiety and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05242939
- Acronym / sponsor ID
- Inhalation Therapy in Children
- Conditions
- Child, Only, Inhalation Therapy; Complications
- Keywords
- inhalation therapy, child, fear, cartoon, video game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Group of Cartoons | Experimental | Other: Watching cartoonsThe 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. |
| The Group of Game | Experimental | Other: Video game723 / 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. |
| 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Having a neurological disorder,
- Congenital anomaly,
- Growth and development retardation,
- Hearing impaired,
- Having visual impairment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video gameThe 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. | Other | The Group of Game |
| Watching cartoonsThe 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. | Other | The Group of Cartoons |
Primary outcome
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
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.
4 secondary outcomes
Pulse oximetry
Time frame: 1 year
Heartbeat
Time frame: 1 year
Respiratory
Time frame: 1 year
Spo2
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 32289071Alhaider 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.
- Background: PubMed 20338620Amirav 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.
- Background: PubMed 21859275Ari 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.
- Background: PubMed 27112434Aydin 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.
- Background: PubMed 20348361Fernandes 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.
- Background: PubMed 26070582DiBlasi 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.
- Background: PubMed 33742204Durak 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.
- Background: PubMed 24094126Ersig 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.
- Background: PubMed 19583650Tufekci 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.
- Background: PubMed 24270011Kwok 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.
- Background: PubMed 25817062Mutlu 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.
- Background: PubMed 28378139Risaw 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.
- Effectiveness Of '' Animated Cartoons '' As A Distraction Strategy On Behavior Response To Pain Perception Among Children Undergoing. VenipunctureLink provided by the sponsor.
- The Effect of Distraction Technique on the Pain of Dressing Change among 3-6 Year-old ChildrenLink provided by the sponsor.
- Effects of Distraction on Physiologic Indices and Pain Intensity in children aged 3-6 Undergoing IV InjectionLink provided by the sponsor.
- Primary out comeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uğur Gül principal investigator
Akdeniz Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game and Watching cartoons in people with Child, Only and Inhalation Therapy; Complications, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (CFS) Measure (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242939, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.