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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-02-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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COPD COPD Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

In the study, blinding will be performed only in the assignment-randomisation to groups and statistical analysis of the results.

Study Groups

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interventional

group applying the stress ball during the CPAP procedure

Group Type EXPERIMENTAL

stress ball

Intervention Type OTHER

Patients squeeze the stress ball

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stress ball

Patients squeeze the stress ball

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No