Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

N/AEnrolling By InvitationNCT07752004

Istanbul University50 enrolled

Overview

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.

Non-invasive mechanical ventilation is the first-line ventilatory support modality for treating acute respiratory failure in patients hospitalized with type II respiratory failure. However, pain, anxiety, and impaired patient comfort experienced during treatment are among the principal factors affecting adherence to Non-invasive mechanical ventilation. These factors may shorten the duration of therapy, reduce mask tolerance, and increase pain associated with mask-related pressure. In recent years, distraction techniques have been increasingly employed to alleviate treatment-related discomfort. One such method is the use of a stress ball. Rhythmic squeezing of the stress ball in the palm provides physical stimulation of muscles and peripheral nerve endings, thereby redirecting the patient's attention away from unpleasant stimuli. This mechanism is thought to produce an acupuncture-like effect, eliciting an analgesic response and reducing pain perception. Furthermore, stress ball use has been reported to stimulate endorphin release, contributing to reductions in anxiety, pain, and stress. Recent nursing research has demonstrated the widespread use of stress balls as a distraction technique across patients of all age groups, particularly among individuals undergoing oncology treatments, haemodialysis, and minor surgical procedures in paediatric settings. To date, only one study has been identified that evaluated the effects of stress ball use on pain and anxiety in patients receiving Non-invasive mechanical ventilation. In Şeker's study, the intervention was applied to patients with chronic obstructive pulmonary disease; however, its effects on treatment duration and mask adherence were not investigated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change From Baseline Treatment Time

The total duration (in minutes) of non-invazive mechanical ventilation received by each patient during two consecutive treatment periods will be recorded.

Time frame: Up to 2 hours

Change From Baseline Anxiety

The Faces Anxiety Scale is a self-report instrument used to assess patients' anxiety levels. Patients evaluate their own anxiety by selecting the facial expression that best reflects how they feel. The scale, measuring 11 × 42 cm, consists of five facial expressions arranged from left to right. The leftmost face represents the absence of anxiety, whereas the level of anxiety increases progressively toward the right. The scale is scored from 0 to 5, with a score of ≥3 indicating moderate to high levels of anxiety. The Faces Anxiety Scale assessments will be performed by a nurse who is independent of the study. Before data collection, the researcher will provide standardized training on the administration of the scale. Following an explanation and demonstration of the assessment procedure using two patients, the nurse will independently assess anxiety in two additional patients under the researcher's supervision. Any deficiencies or inaccuracies in the assessment process will be

Time frame: Up to 2 hours

Secondary Outcomes

Mask adherence

Mask tolerance will be assessed using the Patient Mask Compliance Scale developed by Ali et al. Written permission to use the scale was obtained from the original authors. The scale is scored on a four-point ordinal scale as follows: 1 = Poor (the patient removes the mask); 2 = Fair (mask ventilation continues only with verbal encouragement); 3 = Good (the patient experiences minimal discomfort and does not wish to remove the mask); and 4 = Excellent (the patient is fully compliant with mask ventilation). The scale will be completed by the researcher one hour after the initiation of NIMV and again at the end of the treatment session. In addition, patients will be continuously observed throughout the treatment period to evaluate their mask tolerance.

Time frame: Up to 2 hours

Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes