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Clinical Trials/NCT06461169
NCT06461169
Completed
Not Applicable

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

Kafkas University1 site in 1 country68 target enrollmentJune 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Kafkas University
Enrollment
68
Locations
1
Primary Endpoint
face anxiety scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2024
End Date
February 15, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Huseyin Seker

nurse

Kafkas University

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

Outcomes

Primary Outcomes

face anxiety scale

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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