The Effect of Stress Ball Use on Treatment Duration, Anxiety, and Mask Adherence in Patients Receiving Non-Invasive Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline Treatment Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Aged 18 years or older.
- •Glasgow Coma Scale score ≥
- •Richmond Agitation-Sedation Scale score between +2 and -
- •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.
排除标准
- •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.
研究组 & 干预措施
Without stress ball
Patients were observed throughout the 2-hour treatment session without using a stress ball
With stress ball
Patients were observed throughout the 2-hour treatment session with using a stress ball
干预措施: With stress ball (Other)
结局指标
主要结局
Change From Baseline Treatment Time
时间窗: Up to 2 hours
The total duration (in minutes) of non-invazive mechanical ventilation received by each patient during two consecutive treatment periods will be recorded.
Change From Baseline Anxiety
时间窗: Up to 2 hours
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
次要结局
- Mask adherence(Up to 2 hours)
研究者
Nurten Ozen
Professor
Istanbul University