The Effect of Stress Ball on COPD Patients Receiving Noninvasive Mechanical Ventilation Support

COPD Clinical Trial

Official title:

The Effect of Stress Ball on Pain, Anxiety and Physiological Parameters in COPD Patients Receiving Noninvasive Mechanical Ventilation Support

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461169
• Other study ID #: KafkasUniversity
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: June 2024
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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
• Elderly patients with a Standardised Mini Mental Test (SMMT) score of 24 and above,

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
• Previously participated in an application such as stress ball etc.
• Elderly patients with a Standardised Mini Mental Test (SMMT) score of 23 or less

Related Conditions & MeSH terms

• COPD
• Mechanical Ventilation Pressure High

Intervention

Other:
• stress ball
Patients squeeze the stress ball

Locations

Country	Name	City	State
Turkey	Kafkas University	Kars	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Kafkas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	face anxiety scale	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.	change in anxiety score before and after the intervention
Primary	Visual Analogue Scale (Pain) Visual analog scale (VAS)	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.	change in pain score before and after the intervention
Secondary	systolic blood pressure (mm/Hg)	the effect of the intervention on systolic blood pressure is examined	at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Secondary	diastolic blood pressure (mm/Hg)	the effect of the intervention on diastolic blood pressure is examined	at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Secondary	SpO2-peripheral oxygen saturation (%)	the effect of the intervention on peripheral oxygen saturation is examined	at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Secondary	respiratory rate (minute value)	the effect of the intervention on respiratory rate is examined	at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Secondary	heart rate (minute value)	the effect of the intervention on heart rate is examined	at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention