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

NCT06461169 | Completed

• 1 other identifier: KafkasUniversity
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD; COPD Exacerbation

Keywords

anxiety; pain; CPAP; vital signs

Outcome Measures

Primary Outcomes (2)

• 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 at the beginning of the intervention and 1 hour later

• 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 at the beginning of the intervention and 1 hour later

Secondary Outcomes (5)

• systolic blood pressure (mm/Hg)

  at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention

• diastolic 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

• respiratory rate (minute value)

  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 Arms (2)

interventional

EXPERIMENTAL

group applying the stress ball during the CPAP procedure

Other: stress ball

control

NO INTERVENTION

The group in which no intervention was carried out and the routine care was provided by the nurses during the CPAP procedure

Interventions

stress ball OTHER

Patients squeeze the stress ball

interventional

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University

Kars, Merkez, 36000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In the study, blinding will be performed only in the assignment-randomisation to groups and statistical analysis of the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: June 14, 2024
• Study Start: June 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: February 15, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

TU (1)