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NCT Number: NCT06461169

The Effect of Stress Ball on 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).

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Key information

Conditions

COPD Anxiety Disorders COPD Exacerbation Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafkas University

Kars, Merkez, 36000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress ball

Other

Patients squeeze the stress ball

Primary outcomes

  1. 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.

  2. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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