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

NCT06297356 | Recruiting

• 1 other identifier: YCEYHAN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation Therapy; Complications

Keywords

nebuliser; inhalers; dyspnea; anxiety level

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 4 months.

Secondary Outcomes (4)

• Vital signs: Respiratory rate

  Through study completion, an average of 4 months.

• Vital signs: Pulse

  Through study completion, an average of 4 months.

• Vital signs: Blood pressure

  Through study completion, an average of 4 months.

• saturation

  Through study completion, an average of 4 months.

Study Arms (2)

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.

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.

Interventions

Stress ball DEVICE

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Yasemin CEYHAN

Kırşehir, Center, 40100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yasemin CEYHAN, PhD

CONTACT

+9054645898065; yasemin-ceyhan@hotmail.com

Yasemin CEYHAN

CONTACT

+9054645898065; yasemin-ceyhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 7, 2024
• Study Start: October 1, 2023
• Primary Completion: February 19, 2024
• Study Completion: April 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)