By InvitationNot Applicable

Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

Turkey (Türkiye)50 participantsStarted 2026-06-01

Plain-language summary

Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Stress balls have been widely used as a distraction technique to reduce pain, anxiety, and stress by redirecting attention and promoting endorphin release. Although previous nursing studies have demonstrated their benefits in various clinical settings, evidence regarding their use in patients receiving Non-invasive mechanical ventilation is limited. To date, only one study has evaluated stress ball use in patients with chronic obstructive pulmonary disease receiving Non-invasive mechanical ventilation, focusing on pain and anxiety without assessing treatment duration or mask adherence. This study aims to evaluate the effects of stress ball use on treatment duration, anxiety, and mask adherence in patients receiving Non-invasive mechanical ventilation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Physician-confirmed diagnosis of type II respiratory failure. * Receiving non-invasive mechanical ventilation support for at least 8 hours. * Receiving non-invasive mechanical ventilation mode. * Awake and able to communicate between 08:00 and 24:00. * Aged 18 years or older. * Glasgow Coma Scale score ≥13. * Richmond Agitation-Sedation Scale score between +2 and -1. * Conscious and cooperative (except for transient impairment of consciousness attributable to hypercapnia). * Able to communicate in Turkish. * Written informed consent provided by the patient or, where applicable, the patient's legal representative. Exclusion Criteria: * Presence of delirium, active psychosis, neurological deficits, cognitive impairment, or any condition that precludes effective communication. * Presence of infection, wounds, burns, casts, traction devices, amputation, or any other condition affecting the hands or upper extremities that would prevent squeezing a stress ball. * Hemodynamic instability during non-invasive mechanical ventilation treatment. * Sleeping during non-invasive mechanical ventilation treatment. * Requirement for endotracheal intubation during the study period. * History of facial surgery, facial trauma, facial deformity, or facial burns. * Withdrawal from the study at the participant's own request.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline Treatment Time

Timeframe: Up to 2 hours

Change From Baseline Anxiety

Timeframe: Up to 2 hours

Trial details

NCT IDNCT07752004

SponsorIstanbul University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-01

View on ClinicalTrials.gov More Non Invasive Ventilation (NIV) trials