Stress Ball Use in Non-Invasive Mechanical Ventilation Patients

Official title

The Effect of Stress Ball Use on Treatment Duration, Anxiety, and Mask Adherence in Patients Receiving Non-Invasive Mechanical Ventilation

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.

Detailed description

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.

Interventions

• Other With stress ball
  Participants were instructed to continuously squeeze the stress ball during the 2-hour treatment period

Primary outcome measures

• Change From Baseline Treatment Time [Time frame: Up to 2 hours]
• Change From Baseline Anxiety [Time frame: Up to 2 hours]

Secondary outcome measures (1)

• Mask adherence [Time frame: Up to 2 hours]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Istanbul University — Istanbul

Publications

• Smith TA, Disler RT, Jenkins CR, Ingham JM, Davidson PM. Perspectives on advance care planning among patients recently requiring non-invasive ventilation for acute respiratory failure: A qualitative study using thematic analysis. Palliat Med. 2017 Jun;31(6):566-574. doi: 10.1177/0269216316670286. Epub 2016 Oct 25. PMID 28440124
• Sorensen D, Frederiksen K, Groefte T, Lomborg K. Striving for habitual well-being in noninvasive ventilation: a grounded theory study of chronic obstructive pulmonary disease patients with acute respiratory failure. J Clin Nurs. 2014 Jun;23(11-12):1726-35. doi: 10.1111/jocn.12322. Epub 2013 Sep 13. PMID 24028684
• Volpato E, Banfi PI, Pagnini F. Acceptance and adherence to non-invasive positive pressure ventilation in people with chronic obstructive pulmonary disease: a grounded theory study. Front Psychol. 2023 Aug 3;14:1134718. doi: 10.3389/fpsyg.2023.1134718. eCollection 2023. PMID 37599749
• Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9. PMID 27401047

Identifiers

NCT: NCT07752004 · 2026/144

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗