Inhalation Therapy; ComplicationsNCT06297356
The Effect of Stress Ball Utilisation on Treatment Duration, Dyspnea Severity and Anxiety Level in Nebuliser Therapy
A study testing Stress ball in people with Inhalation Therapy; Complications, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inhalation Therapy; Complications
- What is being tested?
- Stress ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasemin CEYHAN
Kırşehir, Center, 40100
Yasemin CEYHAN, PhD, +9054645898065, yasemin-ceyhan@hotmail.com
yasemin-ceyhan@hotmail.com
About this study
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
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.
Read more
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.
- Conditions
- Inhalation Therapy; Complications
- Being tested
- Stress ball
- Keywords
- nebuliser, inhalers, dyspnea, anxiety level
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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. Receives: Device: Stress ball |
| Control | No intervention | Patients in this group will receive nebuliser therapy at least twice a day. However, no intervention will be made in the meantime. Measurements will be taken before and after any nebulizer treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea severity
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.
Measured: Through study completion, an average of 4 months.
anxiety levels
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.
Measured: Through study completion, an average of 4 months.
treatment duration
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.
Measured: Through study completion, an average of 4 months.
Secondary outcomes (4)
Vital signs: Respiratory rate
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.
Measured: Through study completion, an average of 4 months.
Vital signs: Pulse
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.
Measured: Through study completion, an average of 4 months.
Vital signs: Blood pressure
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.
Measured: Through study completion, an average of 4 months.
saturation
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.
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Oct 2023
- Primary completion19 Feb 2024
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297356
- Sponsor's protocol ID
- YCEYHAN
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06297356
- Acronym / sponsor ID
- YCEYHAN
- Conditions
- Inhalation Therapy; Complications
- Keywords
- nebuliser, inhalers, dyspnea, anxiety level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Stress ballThis 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. |
| Control | No intervention | –Patients in this group will receive nebuliser therapy at least twice a day. However, no intervention will be made in the meantime. Measurements will be taken before and after any nebulizer treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ballStress 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. | Device | intervention |
Primary outcome
dyspnea severity
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Vital signs: Respiratory rate
Time frame: Through study completion, an average of 4 months.
Vital signs: Pulse
Time frame: Through study completion, an average of 4 months.
Vital signs: Blood pressure
Time frame: Through study completion, an average of 4 months.
saturation
Time frame: Through study completion, an average of 4 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball in people with Inhalation Therapy; Complications, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin CEYHAN, PhD (+9054645898065, yasemin-ceyhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dyspnea severity (time frame: Through study completion, an average of 4 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.