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InhalationINHALATIONNCT06197646

Inhalation Therapy and Therapeutic Play

A study testing Cartoon characters inhaler mask in people with Inhalation and Respiratory Disease, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in… Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Inhalation, Respiratory Disease
What is being tested?
Cartoon characters inhaler mask
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2023to 1 Jul 2024
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 3 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Being between the ages of 3-12
  • Being in a pediatric clinic
  • Being diagnosed with respiratory system diseases
  • Being on inhaler therapy as part of routine treatment
  • Self and parent's consent to participate in the study

Who cannot join

  • Having a cognitive or neurological problem
  • Not taking inhaler therapy routinely
  • Being a foreign national

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul, Zeytınburnu, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Using Masks With Cartoon Heroes on Treatment Compliance and Parental Satisfaction in Inhaler Therapy Applications in Children

The aim of this clinical research study was to determine the effect of the use of a cartoon character mask on treatment compliance and parental satisfaction and to evaluate the effectiveness of the cartoon character mask in children receiving inhaled therapy for the treatment of respiratory system diseases in children.

The hypotheses it aims to answer are as follows:

Read more

H1: Inhalers given using a mask with a cartoon character facilitate treatment compliance.

H2: The inhaler given using a mask with a cartoon character makes treatment compliance difficult.

H3: Inhaler treatment using a mask with a cartoon hero increases parental satisfaction.

H4: Inhaler treatment using a mask with a cartoon hero decreases parental satisfaction.

H5: Inhaler treatment using a mask with a cartoon hero has a positive effect on the hospitalization process.

H6: Inhaler treatment using a mask with a cartoon hero has a positive effect on the recovery process.

H7: Compared to routine inhaler mask use, the use of masks with cartoon heroes provides a positive relationship between treatment adherence and parental satisfaction.

In the study, according to randomization, the intervention group will receive inhalers with masks, and the other group will receive inhalers routinely used in the clinic. The treatment of the children was planned by the physician, and no additional treatment was given for the study. Children's adherence to treatment and parents; satisfaction will be evaluated. The effectiveness of the masked inhaler used will be asked.

Read the detailed description

Respiratory diseases are among the most common diseases in childhood and are among the most important causes of infectious disease-related mortality and morbidity worldwide. Approximately 1 in 3 children have a lower respiratory tract infection in the first year of life. Respiratory tract infections are more common in developing countries and have a worse prognosis. According to World Health Organization data, respiratory tract infections constitute 13% of the causes of mortality in children under 5 years of age. Respiratory tract diseases are frequently seen during seasonal transitions in childhood and are caused by viral or bacterial agents. Treatment of respiratory tract diseases differs as outpatient or inpatient depending on the agent and the condition of the child. In addition to antibiotherapy, relaxing and supportive treatments are also included in the treatment. These include analgesics, antipyretics, decongestants, and antihistamines. These treatments are administered orally, parenterally, or inhaled. In inhaler treatment, medication is given by placing it into a pediatric mask with a reservoir. This treatment method is boring, frightening, and anxiety-inducing for the pediatric age group and makes it difficult to comply with the treatment. Various methods are being tried to facilitate compliance with treatment in children. One of these methods is play-based treatment activities.

Play is a form of learning that facilitates children's adaptation to the outside world by providing them with new experiences, skills, and social responsibility, and enables them to communicate by exploring their environment. Play is defined by the United Nations High Commission for Human Rights as the right of every child that contributes to the development of the child. In the literature, it is reported that play is effective in reducing the anxiety and fear of hospitalized children and is necessary to provide holistic and quality care. It has also been reported that it does not benefit their recovery by relaxing them both physically and emotionally.

Games are categorized under four headings according to their purpose: entertaining and distracting games, games that support the development of cognitive, social, and sensorimotor skills, games that teach right and wrong, provide socialization, make people aware of and accept their biological existence as men or women, and therapeutic games to relieve anxiety and tension. Games can be used in clinics as healing practices (therapeutic practices). Although therapeutic play and play therapy are used interchangeably, they are conceptually and practically quite different. The spontaneous creation of activities using toys without predetermined goals is referred to as play therapy.

Therapeutic play that activates physiological functions is used in cases where the child exhibits regressive behavior, drama therapeutic play that allows emotional discharge, and educational/creative therapeutic play is used to prepare children for procedures.

There are three types of therapeutic play:

  1. Energy Expending Play: Children show their aggressive behavior, anger, and anxiety by shouting, punching, and running. To direct these emotions in the hospital, areas for this purpose should be created or appropriate materials should be provided. In this way, their aggressive behavior, anger, and anxiety levels can be reduced.
  2. Dramatic Play: Playing by imitating life and events to understand them better is defined as dramatic play. By using dramatic play, it is ensured that the child expresses his/her feelings about the interventions to be applied in the hospital environment and major events. For this purpose, playing with medical equipment such as masks, stethoscopes, and IV sets during the game can be effective in reducing the stress of children and expressing what they feel.
  3. Creative Play: This is the type of play used to show children how each procedure is done by using materials before and after the procedures. In creative play, methods such as drawing pictures, sentence completion, and three wishes tests are used to collect information about the inner world of the child.

The main aim of the therapeutic relationship in pediatric nursing is to maintain the health, growth, and development of the child and his/her family at the highest possible level. Nurses help children and their parents to maintain their health and develop adaptation by gaining effective coping skills in case of illness or any lifestyle change.

Nurses can use play as a health care strategy for hospitalized children in three areas. The first of these areas is its use in routine practices. Secondly, it is recommended to use it in preparation for surgical or invasive interventions and finally during painful and unpleasant procedures.

For nurses, play is key to understanding the child. Therapeutic play helps children to express their feelings and thoughts verbally or non-verbally about the procedures to be applied. The nurse adapts therapeutic play to care and provides nursing care in line with the information gathered through play. Florence Nightingale, the founder of modern nursing, emphasized the necessity of play for hospitalized children. Studies have reported that therapeutic play practice contributes to holistic and specific nursing care and that therapeutic play is an effective method. However, it was found that most of them did not use it in daily nursing practices due to reasons such as lack of time.

In the last decade, it has been known that showing videos and distributing booklets and coloring books to children at the pre-anesthetic visit is beneficial. Arranging the anesthesia mask to resemble popular characters among children (such as birds, and cartoon characters), having children put the masks on their faces and look at the fun face mask in the mirror and blowing on the balloon, making it look like a magic ball, allowing children to stick the stickers they like on the anesthesia mask as a game facilitates induction of anesthesia. With pharmacological premedication appropriate to these nonpharmacological methods, anxiety can be prevented, psychological injuries can be reduced, induction of anesthesia can be facilitated, and preoperative anxiety of the child can be reduced.

Being tested
Cartoon characters inhaler mask
Keywords
inhaler therapy, children, inhalation, therapeutic play, nursing
Medical subject headings
Respiratory Aspiration, Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cartoon characters inhaler maskDevice

    Cartoon characters inhaler mask

Study groups in NCT06197646
Study groupRoleWhat they receive
Inhaler mask with cartoon charactersExperimentalInhalation therapy with cartoon characters inhaler mask and Inhaler therapy training
Receives: Device: Cartoon characters inhaler mask
Inhaler maskNo interventionInhalation therapy with the inhaler mask routinely used by the clinic and Inhaler therapy training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment compliance

    The primary outcome of the study will be to determine children's compliance with inhalation therapy with an inhaler mask.

    Measured: 6 months

Secondary outcomes (1)
  1. Effectiveness and usefulness of the treatment tool

    As a secondary result, the effectiveness and usefulness of the cartoon character mask developed within the framework of therapeutic play will be evaluated.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start1 Aug 2023
  3. Primary completion1 Nov 2023
  4. Study completion1 Jul 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled study
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06197646
Sponsor's protocol ID
23/185
Acronym
INHALATION
Status last verified
Dec 2023
First submitted
11 Dec 2023
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Once completed, the study will be published in a scientific journal. After publication, IPD will be shared upon request. Researchers will have access to the IPD. The materials and methods section will be shared upon reasonable request.

Publications

  • undefined

  • Gül, O. (2015). The effect of game on pre-school period (ages 3-6): A review of study. Turkish Journal of Sport and Exercise, 17(3), 1. https://doi.org/10.15314/tjse.

  • Ginsburg KR; American Academy of Pediatrics Committee on Communications; American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health. The importance of play in promoting healthy child development and maintaining strong parent-child bonds. Pediatrics. 2007 Jan;119(1):182-91. doi: 10.1542/peds.2006-2697.

    PubMed 17200287
  • Francischinelli, A. G., Almeida, F. A. &, & Fernandes, M. S. (2012). Routine use of therapeutic play in the care of hospitalized children: nurses' perceptions. Acta Paul Enferm, 25(1), 18-23. https://doi.org/10.1590/S0103- 21002012000100004

  • Çavuşoğlu H. (2013). Child Health Nursing. Ankara: System Ofset Printing House: p. 67-69

  • Çiftçi, E. N. (2011). The effect of visual and auditory premedication on mask induction in children. Trakya University, Faculty of Medicine, Specialization Thesis (Advisor Sevtap Hekimoğlu Şahin), Edirne.

  • Berna, I. K., Ceren, Ç., & Esenay Figen. (2013). Therapeutic play: the key to communication with the sick child. Ankara Journal of Health Sciences, 2(123), 1-10. https://doi.org/10.1501/Asbd_0000000038

  • Aydin T, Sahin L, Algin C, Kabay S, Yucel M, Hacioglu A, Yaylak F, Kilicoglu A. Do not mask the mask: use it as a premedicant. Paediatr Anaesth. 2008 Feb;18(2):107-12. doi: 10.1111/j.1460-9592.2007.02381.x.

    PubMed 18184240
  • Altay, N. C. (2008). Preoperative preparation in children. Hacettepe University Faculty of Health Sciences Nursing Journal, 68-76.

  • Koukourikos K, Tzeha L, Pantelidou P, Tsaloglidou A. THE IMPORTANCE OF PLAY DURING HOSPITALIZATION OF CHILDREN. Mater Sociomed. 2015 Dec;27(6):438-41. doi: 10.5455/msm.2015.27.438-441.

    PubMed 26889107

Questions about this trial

What is this clinical trial studying?

A study testing Cartoon characters inhaler mask in people with Inhalation and Respiratory Disease, run by Istinye 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 3 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 2 May 2025. 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?

Treatment compliance (time frame: 6 months). 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 NCT06197646, which also lists 10 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 2 May 2025.

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