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

March 2, 2025 updated by: Huseyin Seker, Kafkas University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Kars, Merkez, Turkey, 36000
        • Kafkas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional
group applying the stress ball during the CPAP procedure
Other: stress ball
Patients squeeze the stress ball
No Intervention: control
The group in which no intervention was carried out and the routine care was provided by the nurses during the CPAP procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in anxiety score at the beginning of the intervention and 1 hour later
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.
Change in pain score at the beginning of the intervention and 1 hour later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
systolic blood pressure (mm/Hg)
Time Frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
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
diastolic blood pressure (mm/Hg)
Time Frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
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
SpO2-peripheral oxygen saturation (%)
Time Frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
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
respiratory rate (minute value)
Time Frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
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
heart rate (minute value)
Time Frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafkas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KafkasUniversity

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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