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

February 29, 2024 updated by: Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
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.
Device: Stress 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.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.
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.
Through study completion, an average of 4 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs: Respiratory rate
Time Frame: 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.
Through study completion, an average of 4 months.
Vital signs: Pulse
Time Frame: 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.
Through study completion, an average of 4 months.
Vital signs: Blood pressure
Time Frame: 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.
Through study completion, an average of 4 months.
saturation
Time Frame: 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.
Through study completion, an average of 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsehir Ahi Evran Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

February 19, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YCEYHAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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