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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2024-12-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment

NCT05213013

Children, Only Fear Anxiety Hospitalism in Children

UNKNOWN NA

Active and Passive Distraction Techniques

NCT05242939

Child, Only Inhalation Therapy; Complications

COMPLETED NA

The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level

NCT05415566

Therapeutic Play Anxiety Fear

COMPLETED NA

The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children

NCT06339112

Fear Anxiety Inhalant Use

COMPLETED NA

Effect of Cartoon and Storytelling on the Children's Fear and Anxiety Levels During Inhalation Therapy With Nebulizer in Emergency Department

NCT07029633

Distraction Methods Child

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In the literature, distraction techniques are generally used in invasive procedures. On the other hand, it is possible that studies on the effects of inhalation therapy and non-pharmacological methods, which are among the common non-invasive interventions in children, can still continue. Durak et al. (2021) stated that the developments in experimental groups, in which they were made to watch cartoons during inhalation treatment, were lower in adults than in control groups and in children. A similar study was published by Ozsamuri (2020), and children receiving mask and inhaler treatment consisted of watching cartoons, listening to music, and a control group. As a result of the study, intra-group comparisons show that the fear and anxiety scores of people in cartoon and music groups decreased compared to before the procedure . However, arranging emergency services for children and selling them with treatment materials have been shown to be effective in reducing children's fears. Negative reactions to the growth mask and nebulizer during inhaler therapy, causing incorrect inhalation patterns, and deterioration are reduced. Yanık and Ayyıldız (2019) conducted a study on the effectiveness of the training given with a toy-type nebulizer for children aged 3-6 years who received nebulizer therapy. During the therapy inhaler treatment, the scores of the people in the experimental group decreased, while the scores of the control group increased. Kırkan (2023) stated that the therapeutic play method applied with toy nebulizers and toy nebulizers in the activities he conducted with 3-8 year old children who received nebulizers is an effective method treatment in reducing fear and anxiety in the children's hospital. Distracting methods during inhaler treatment for children are beneficial for patients to have positive hospital experiences. This will reduce patients' fear of the hospital, prevent providers from experiencing stress, and ensure that people are satisfied. Adequate information during treatment procedures in children will improve fear, pain and anxiety management and increase the positive hospital experience. Rapid healing is important because of the reduced use of treatment materials, the effectiveness of human resources, and the increase in health knowledge.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Inhalation Therapy; Complications Fear Distraction Methods Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

normal nebulizer + mask + distraction technique

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

toy type nebulizer + toy mask

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type BEHAVIORAL

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,

Exclusion Criteria

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No