Clinical trial NCT06461169: The Effect of Stress Ball on COPD Patients Receiving Noninvasive Mechanical Ventilation Support
Official title: The Effect of Stress Ball on Pain, Anxiety and Physiological Parameters in COPD Patients Receiving Noninvasive Mechanical Ventilation Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
COPD Exacerbation
Keywords: anxiety
pain
CPAP
vital signs
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomisation will be used to ensure that the number of patients in each group is balanced. Patients will be divided into two groups, each group consisting of at least 30 people, by a statistician who is not involved in the study, using a table of random numbers.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: face anxiety scale
timeFrame: Change in anxiety score at the beginning of the intervention and 1 hour later
measure: Visual Analogue Scale (Pain) Visual analog scale (VAS)
timeFrame: Change in pain score at the beginning of the intervention and 1 hour later
Secondary outcomes:
measure: systolic blood pressure (mm/Hg)
timeFrame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
measure: diastolic blood pressure (mm/Hg)
timeFrame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
measure: SpO2-peripheral oxygen saturation (%)
timeFrame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
measure: respiratory rate (minute value)
timeFrame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
measure: heart rate (minute value)
timeFrame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University
state: Merkez
Study officials:
References: