Clinical trial NCT06297356: The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inhalation Therapy; Complications
Keywords: nebuliser
inhalers
dyspnea
anxiety level
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: dyspnea severity
timeFrame: Through study completion, an average of 4 months.
measure: anxiety levels
timeFrame: Through study completion, an average of 4 months.
measure: treatment duration
timeFrame: Through study completion, an average of 4 months.
Secondary outcomes:
measure: Vital signs: Respiratory rate
timeFrame: Through study completion, an average of 4 months.
measure: Vital signs: Pulse
timeFrame: Through study completion, an average of 4 months.
measure: Vital signs: Blood pressure
timeFrame: Through study completion, an average of 4 months.
measure: saturation
timeFrame: Through study completion, an average of 4 months.
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Yasemin CEYHAN
state: Center
Study officials:
References: