COPDNCT06461169
The Effect of Stress Ball on COPD Patients Receiving Noninvasive Mechanical Ventilation Support
A study testing stress ball in people with COPD and COPD Exacerbation, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- COPD, COPD Exacerbation
- What is being tested?
- stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- COPD, COPD Exacerbation
- Being tested
- stress ball
- Keywords
- anxiety, pain, CPAP, vital signs
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ballOther
Patients squeeze the stress ball
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | group applying the stress ball during the CPAP procedure Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in pain score at the beginning of the intervention and 1 hour later
Secondary outcomes (5)
systolic blood pressure (mm/Hg)
the effect of the intervention on systolic blood pressure is examined
Measured: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
diastolic blood pressure (mm/Hg)
the effect of the intervention on diastolic blood pressure is examined
Measured: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
SpO2-peripheral oxygen saturation (%)
the effect of the intervention on peripheral oxygen saturation is examined
Measured: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
respiratory rate (minute value)
the effect of the intervention on respiratory rate is examined
Measured: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
heart rate (minute value)
the effect of the intervention on heart rate is examined
Measured: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Seker, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461169
- Sponsor's protocol ID
- KafkasUniversity
- Status last verified
- Mar 2025
- First submitted
- 9 May 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball on Pain, Anxiety and Physiological Parameters in COPD Patients Receiving Noninvasive Mechanical Ventilation Support
- ClinicalTrials.gov ID
- NCT06461169
- Acronym / sponsor ID
- KafkasUniversity
- Conditions
- COPD, COPD Exacerbation
- Keywords
- anxiety, pain, CPAP, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Other: stress ballgroup applying the stress ball during the CPAP procedure |
| 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 |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with COPD
- Receiving CPAP therapy
- Those who voluntarily agreed to participate in the study
- Turkish speaking, understanding,
- No cognitive and cognitive problems
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ballPatients squeeze the stress ball | Other | interventional |
Primary outcome
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.
5 secondary outcomes
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
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
SpO2-peripheral oxygen saturation (%)
Time frame: 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
heart rate (minute value)
Time frame: at the beginning of the intervention and at the 15th, 30th, 45th and 60th minutes of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball in people with COPD and COPD Exacerbation, run by Kafkas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
face anxiety scale (time frame: Change in anxiety score at the beginning of the intervention and 1 hour later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.