The Effect of Stress Ball on Pain, Anxiety and Physiological Parameters in COPD Patients Receiving Noninvasive Mechanical Ventilation Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- face anxiety scale
研究概览
简要总结
The aim of this randomised controlled trial was to investigate the effect of a stress ball on pain, anxiety and physiological parameters in Chronic Obstructive Pulmonary Disease (COPD) patients on non-invasive mechanical ventilation (NIMV).
详细描述
Continuous Positive Airway Pressure (CPAP) therapy used in NIMV reduces the need for IMV in COPD patients and shortens hospital stays. Negative states resulting from the difficulty of treatment lead to increased pain and anxiety in patients and negative results in vital signs. There is a need for non-invasive, low-cost and easy-to-use methods that can be used by nurses to address these problems in patients. This study will investigate the effect of a stress ball on changes in pain, anxiety and vital signs in patients diagnosed with COPD and receiving CPAP treatment during treatment. The stress ball will be applied to the patients during two consecutive CPAP treatments and pain, anxiety scores and vital signs will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
In the study, blinding will be performed only in the assignment-randomisation to groups and statistical analysis of the results.
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD
- •Receiving CPAP therapy
- •Those who voluntarily agreed to participate in the study
- •Turkish speaking, understanding,
- •No cognitive and cognitive problems
- •glasgow coma scale score of 13 and above
- •Those who have not participated in stress ball etc. application before
排除标准
- •Refused to participate in the research
- •People with visual and hearing impairment
- •unable to speak and understand Turkish
- •Cognitive and cognitive problems
- •glasgow coma scale<13
- •Infection, wound, burn, plaster, traction etc. in the hand and arm area
- •During the research, those who wanted to leave voluntarily
- •General condition deteriorated during NIMV treatment
结局指标
主要结局
face anxiety scale
时间窗: Change in anxiety score at the beginning of the intervention and 1 hour later
Developed in 2003, the Facial Anxiety Scale is a measurement tool in which patients self-report their anxiety levels and is 11 × 42 cm in size. It consists of five face shapes, the leftmost facial expression indicates the absence of anxiety, while the level of anxiety increases towards the right (scored between 0-5). According to the Facial Anxiety Scale, a score of 3 and above by the patients indicates that the level of anxiety is at medium and high levels.
Visual Analogue Scale (Pain) Visual analog scale (VAS)
时间窗: Change in pain score at the beginning of the intervention and 1 hour later
Visual analog scale is used to convert parameters that cannot be measured numerically into a numerical value. For pain, '0: I have no pain and 10: I have unbearable/severe pain' is written on one end of a 100 mm line and the patient marks his/her current condition on this line.
次要结局
- diastolic blood pressure (mm/Hg)(at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention)
- respiratory rate (minute value)(at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention)
- systolic blood pressure (mm/Hg)(at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention)
- SpO2-peripheral oxygen saturation (%)(at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention)
- heart rate (minute value)(at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention)