The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety

NCT06510166 | Active Not Recruiting DMC

• 1 other identifier: OndokusMK
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety. Hypothesis: Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group. Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group. Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group. Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.

Conditions

Child; Inhalation Therapy; Complications; Fear; Distraction Methods; Anxiety

Keywords

child; inhalation theraphy; fear; distraction methods; anxiety

Outcome Measures

Primary Outcomes (2)

• changing the anxiety

  Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.

  'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

• changing the fear

  Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.

  'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

Study Arms (3)

normal nebulizer + mask + distraction technique

EXPERIMENTAL

Inclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease

Behavioral: Children's Fear and Anxiety normal nebulizer and mask+ distraction

toy type nebulizer + toy mask

ACTIVE COMPARATOR

Inclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease

Behavioral: Children's Fear and Anxiety a toy nebulizer and a toy mask

control group

NO INTERVENTION

Inclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease

Interventions

Children's Fear and Anxiety normal nebulizer and mask+ distraction BEHAVIORAL

Children in group 2 will receive their inhaler treatment with a normal nebulizer and mask, while at the same time one of the distraction techniques of their choice (drawing a picture, reading a story or watching an age-appropriate cartoon) will be applied.

normal nebulizer + mask + distraction technique

Children's Fear and Anxiety a toy nebulizer and a toy mask BEHAVIORAL

Children in Group 3 will receive their inhaler treatment using a toy nebulizer and a toy mask.

toy type nebulizer + toy mask

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent and child volunteer to participate in the study,
• The child is between 3-6 years old,
• Presentation due to upper and lower respiratory tract infection,
• Inhaler treatment will be applied with a nebulizer,
• No request for any other intravenous, intramuscular or invasive treatment,
• The child does not have any genetic, congenital, chronic or metabolic disease,

You may not qualify if:

• Parent and child are not willing to participate in the study,
• The child is not between 3-6 years old,
• Presentation for a reason other than upper and lower respiratory tract infection,
• No inhaler treatment with a nebulizer,
• Request for any other intravenous, intramuscular or invasive treatment,
• The child has any genetic, congenital, chronic or metabolic disease

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (2)

• 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

• Kirkan C, Kahraman A. Effect of therapeutic play using a toy nebulizer and toy mask on a child's fear and anxiety levels. J Pediatr Nurs. 2023 Nov-Dec;73:e556-e562. doi: 10.1016/j.pedn.2023.10.033. Epub 2023 Nov 7.

  PMID: 37940393 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 19, 2024
• Study Start: April 8, 2024
• Primary Completion: October 8, 2024
• Study Completion: December 8, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)