Inhalation Therapy and Therapeutic Play

NCT06197646 | Completed

• 1 other identifier: 23/185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 children. The hypotheses it aims to answer are as follows: 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.

Conditions

Inhalation; Respiratory Disease

Keywords

inhaler therapy; children; inhalation; therapeutic play; nursing

Outcome Measures

Primary Outcomes (1)

• Treatment compliance

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

  6 months

Secondary Outcomes (1)

• Effectiveness and usefulness of the treatment tool

  6 months

Other Outcomes (1)

• Parental satisfaction

  6 moths

Study Arms (2)

Inhaler mask with cartoon characters

EXPERIMENTAL

Inhalation therapy with cartoon characters inhaler mask and Inhaler therapy training

Device: Cartoon characters inhaler mask

Inhaler mask

NO INTERVENTION

Inhalation therapy with the inhaler mask routinely used by the clinic and Inhaler therapy training

Interventions

Cartoon characters inhaler mask DEVICE

Cartoon characters inhaler mask

Inhaler mask with cartoon characters

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University

Istanbul, Zeytınburnu, 34010, Turkey (Türkiye)

Location

Related Publications (10)

• undefined

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17200287 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• Aydın T, Şahin L, Algın C, Kabay Ş, Yücel M, Hacıoğlu A et al. Do not mask the mask: use it a premedicant. Pediatric Anesthesia 2008;18:107-12.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26889107 RESULT

MeSH Terms

Conditions

Respiratory Aspiration; Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysegul Simsek

  Istinye University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 9, 2024
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 2, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)