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The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy

Investigation of the Effect of Stress Ball Utilisation on Treatment Duration, Dyspnoea Severity and Anxiety Level in Patients Receiving Nebuliser Therapy: A Randomised Controlled Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06297356
Enrollment
80
Registered
2024-03-07
Start date
2023-10-01
Completion date
2024-04-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inhalation Therapy; Complications

Keywords

nebuliser, inhalers, dyspnea, anxiety level

Brief summary

Nebul Therapy is very effective in quickly improving the symptoms of respiratory system diseases. While applying this treatment, patients are expected to complete a sufficient period of time. However, this waiting and the symptoms of the disease may cause anxiety in the patient. The aim of the study was to enable patients to spend their nebul period actively by using a stress ball. Thus, it was thought that it would make a positive contribution to dyspnea severity and anxiety levels. The main questions it aims to answer are: Does using a stress ball contribute positively to nebulizer usage time? Is the use of a stress ball effective in reducing the severity of dyspnea? Is using a stress ball effective in reducing anxiety levels? For this purpose, participants will be asked to tighten and loosen the stress ball with one hand during the nebuliser therapy. They will be expected to continue this with at least two nebuliser therapy per day. A control group will be used to determine the effectiveness of the stress ball. This group will not use a stress ball while receiving nebulizer treatment.

Interventions

DEVICEStress ball

Stress balls are soft sponges with a diameter of 2-4 cm. The lightest starting level was preferred for the patients. Patients were allowed to take the stress ball in any hand they wanted. They were asked to squeeze and loosen the ball in their palm at 2-3 second intervals.

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalized for at least three days * Having nebulizer treatment at least twice a day * Medicines that have the same effect as prescribed (bronchodilators) * Patients who are required to have at least 4 ml of medication in the reservoir * Patients who have previous experience of using a nebulizer at home

Exclusion criteria

* Those who have severe exacerbation attacks * People with speech problems * People who experience severe dyspnea due to heart disease * Those with high anxiety levels for any reason (death of a relative, etc.) * Those with muscle or nerve problems in their hands * Those who did not consent to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
dyspnea severityThrough study completion, an average of 4 months.The patient's current dyspnea level is evaluated between 0-10. As it approaches 10, the intensity increases. The patient's dyspnea severity will be recorded before and after nebuliser therapy. This process will be done once.
anxiety levelsThrough study completion, an average of 4 months.describes the patient's current anxiety level. The patient's current anxiety level is determined with the state anxiety scale developed for this purpose. The patient's anxiety levels will be recorded before and after nebuliser therapy. This process will be done once.
treatment durationThrough study completion, an average of 4 months.Defines the time between the start and end of nebuliser therapy. It is expected to be approximately 15-20 minutes. The patient's current condition will be measured. For this reason, it will be applied once.

Secondary

MeasureTime frameDescription
Vital signs: Respiratory rateThrough study completion, an average of 4 months.These are measurements that include the patient's respiratory rate. The patient's respiratory rate will be recorded before and after nebuliser therapy. This process will be done once.
saturationThrough study completion, an average of 4 months.It is the percentage of oxygen saturation of the blood. Measured with a probe from the finger. The patient's saturation levels will be recorded before and after nebuliser therapy. This process will be done once.
Vital signs: PulseThrough study completion, an average of 4 months.These are measurements that include the patient's pulse. The patient's vital signs will be recorded before and after nebuliser therapy. This process will be done once.
Vital signs: Blood pressureThrough study completion, an average of 4 months.These are measurements that include the patient's blood pressure. The patient's vital signs will be recorded before and after nebuliser therapy. This process will be done once.

Countries

Turkey (Türkiye)

Contacts

Primary ContactYasemin CEYHAN, PhD
yasemin-ceyhan@hotmail.com+9054645898065
Backup ContactYasemin CEYHAN
yasemin-ceyhan@hotmail.com+9054645898065

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026