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Enrolling By Invitation
NCT07752004
Stress Ball Use in Non-Invasive Mechanical Ventilation Patients
Conditions: Non Invasive Ventilation (NIV)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Istanbul University
Location: Istanbul University Istanbul
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07752004). StuddyBuddy aggregates publicly available trial information.