Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

Enrolling by invitation · Not applicable

Conditions studied: Non Invasive Ventilation (NIV)

In brief

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.

Key facts

Study ID

NCT07752004

Run by

Istanbul University

People needed

50

Starts

2026-06-01

Expected to finish

2027-07-30

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Istanbul University — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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