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

Not Applicable

Recruiting

• Conditions: Inhalation Therapy; Complications
• Interventions: Device: Stress ball

• Registration Number: NCT06297356
• Lead Sponsor: Kirsehir Ahi Evran Universitesi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-02
• Primary Completion: 2024-02-19
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Stress ball	This group will use a stress ball during nebuliser therapy. This process will be repeated at least twice a day.It will be a single application since the patients' current dyspnea and anxiety levels will be evaluated.

Primary Outcome Measures

Name	Time	Method
dyspnea severity	Through 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 levels	Through 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 duration	Through 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 Outcome Measures

Name	Time	Method
Vital signs: Respiratory rate	Through 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.
Vital signs: Blood pressure	Through 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.
Vital signs: Pulse	Through 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.
saturation	Through 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.

Trial Locations

Locations (1)

Yasemin CEYHAN; 🇹🇷 Kırşehir, Center, Turkey