Non Invasive Ventilation (NIV)NCT07752004
Stress Ball Use in Non-Invasive Mechanical Ventilation Patients
A study testing With stress ball in people with Non Invasive Ventilation (NIV), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Invasive Ventilation (NIV)
- What is being tested?
- With stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-confirmed diagnosis of type II respiratory failure.
- Receiving non-invasive mechanical ventilation support for at least 8 hours.
- Receiving non-invasive mechanical ventilation mode.
- Awake and able to communicate between 08:00 and 24:00.
- Aged 18 years or older.
- Glasgow Coma Scale score ≥13.
Show all 10Show fewer
- Richmond Agitation-Sedation Scale score between +2 and -1.
- Conscious and cooperative (except for transient impairment of consciousness attributable to hypercapnia).
- Able to communicate in Turkish.
- Written informed consent provided by the patient or, where applicable, the patient's legal representative.
Who cannot join
- Presence of delirium, active psychosis, neurological deficits, cognitive impairment, or any condition that precludes effective communication.
- Presence of infection, wounds, burns, casts, traction devices, amputation, or any other condition affecting the hands or upper extremities that would prevent squeezing a stress ball.
- Hemodynamic instability during non-invasive mechanical ventilation treatment.
- Sleeping during non-invasive mechanical ventilation treatment.
- Requirement for endotracheal intubation during the study period.
- History of facial surgery, facial trauma, facial deformity, or facial burns.
- Withdrawal from the study at the participant's own request.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Stress Ball Use on Treatment Duration, Anxiety, and Mask Adherence in Patients Receiving Non-Invasive Mechanical Ventilation
Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Stress balls have been widely used as a distraction technique to reduce pain, anxiety, and stress by redirecting attention and promoting endorphin release. Although previous nursing studies have demonstrated their benefits in various clinical settings, evidence regarding their use in patients receiving Non-invasive mechanical ventilation is limited. To date, only one study has evaluated stress ball use in patients with chronic obstructive pulmonary disease receiving Non-invasive mechanical ventilation, focusing on pain and anxiety without assessing treatment duration or mask adherence. This study aims to evaluate the effects of stress ball use on treatment duration, anxiety, and mask adherence in patients receiving Non-invasive mechanical ventilation.
Read the detailed description
Non-invasive mechanical ventilation is the first-line ventilatory support modality for treating acute respiratory failure in patients hospitalized with type II respiratory failure. However, pain, anxiety, and impaired patient comfort experienced during treatment are among the principal factors affecting adherence to Non-invasive mechanical ventilation. These factors may shorten the duration of therapy, reduce mask tolerance, and increase pain associated with mask-related pressure.
In recent years, distraction techniques have been increasingly employed to alleviate treatment-related discomfort. One such method is the use of a stress ball. Rhythmic squeezing of the stress ball in the palm provides physical stimulation of muscles and peripheral nerve endings, thereby redirecting the patient's attention away from unpleasant stimuli. This mechanism is thought to produce an acupuncture-like effect, eliciting an analgesic response and reducing pain perception. Furthermore, stress ball use has been reported to stimulate endorphin release, contributing to reductions in anxiety, pain, and stress.
Recent nursing research has demonstrated the widespread use of stress balls as a distraction technique across patients of all age groups, particularly among individuals undergoing oncology treatments, haemodialysis, and minor surgical procedures in paediatric settings. To date, only one study has been identified that evaluated the effects of stress ball use on pain and anxiety in patients receiving Non-invasive mechanical ventilation. In Şeker's study, the intervention was applied to patients with chronic obstructive pulmonary disease; however, its effects on treatment duration and mask adherence were not investigated.
- Conditions
- Non Invasive Ventilation (NIV)
- Being tested
- With stress ball
- Keywords
- stress ball
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With stress ballOther
Participants were instructed to continuously squeeze the stress ball during the 2-hour treatment period
| Study group | Role | What they receive |
|---|---|---|
| Without stress ball | No intervention | Patients were observed throughout the 2-hour treatment session without using a stress ball |
| With stress ball | Experimental | Patients were observed throughout the 2-hour treatment session with using a stress ball Receives: Other: With stress ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Treatment Time
The total duration (in minutes) of non-invazive mechanical ventilation received by each patient during two consecutive treatment periods will be recorded.
Measured: Up to 2 hours
Change From Baseline Anxiety
The Faces Anxiety Scale is a self-report instrument used to assess patients' anxiety levels. Patients evaluate their own anxiety by selecting the facial expression that best reflects how they feel. The scale, measuring 11 × 42 cm, consists of five facial expressions arranged from left to right. The leftmost face represents the absence of anxiety, whereas the level of anxiety increases progressively toward the right. The scale is scored from 0 to 5, with a score of ≥3 indicating moderate to high levels of anxiety.
The Faces Anxiety Scale assessments will be performed by a nurse who is independent of the study. Before data collection, the researcher will provide standardized training on the administration of the scale. Following an explanation and demonstration of the assessment procedure using two patients, the nurse will independently assess anxiety in two additional patients under the researcher's supervision. Any deficiencies or inaccuracies in the assessment process will be
Measured: Up to 2 hours
Secondary outcomes (1)
Mask adherence
Mask tolerance will be assessed using the Patient Mask Compliance Scale developed by Ali et al. Written permission to use the scale was obtained from the original authors. The scale is scored on a four-point ordinal scale as follows: 1 = Poor (the patient removes the mask); 2 = Fair (mask ventilation continues only with verbal encouragement); 3 = Good (the patient experiences minimal discomfort and does not wish to remove the mask); and 4 = Excellent (the patient is fully compliant with mask ventilation).
The scale will be completed by the researcher one hour after the initiation of NIMV and again at the end of the treatment session. In addition, patients will be continuously observed throughout the treatment period to evaluate their mask tolerance.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non Invasive Ventilation (NIV)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Single-blind, self-controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul University
- Investigators
- NURTEN ÖZEN, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752004
- Sponsor's protocol ID
- 2026/144
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith TA, Disler RT, Jenkins CR, Ingham JM, Davidson PM. Perspectives on advance care planning among patients recently requiring non-invasive ventilation for acute respiratory failure: A qualitative study using thematic analysis. Palliat Med. 2017 Jun;31(6):566-574. doi: 10.1177/0269216316670286. Epub 2016 Oct 25.
PubMed 28440124Sorensen D, Frederiksen K, Groefte T, Lomborg K. Striving for habitual well-being in noninvasive ventilation: a grounded theory study of chronic obstructive pulmonary disease patients with acute respiratory failure. J Clin Nurs. 2014 Jun;23(11-12):1726-35. doi: 10.1111/jocn.12322. Epub 2013 Sep 13.
PubMed 24028684Volpato E, Banfi PI, Pagnini F. Acceptance and adherence to non-invasive positive pressure ventilation in people with chronic obstructive pulmonary disease: a grounded theory study. Front Psychol. 2023 Aug 3;14:1134718. doi: 10.3389/fpsyg.2023.1134718. eCollection 2023.
PubMed 37599749Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.
PubMed 27401047
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use on Treatment Duration, Anxiety, and Mask Adherence in Patients Receiving Non-Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07752004
- Acronym / sponsor ID
- 2026/144
- Conditions
- Non Invasive Ventilation (NIV)
- Keywords
- stress ball
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 7 Aug 2026 (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.
Non-invasive mechanical ventilation is the first-line treatment for acute respiratory failure in patients with type II respiratory failure. However, pain, anxiety, discomfort, and mask-related pressure may reduce treatment adherence, shorten therapy duration, and impair mask tolerance. Stress balls have been widely used as a distraction technique to reduce pain, anxiety, and stress by redirecting attention and promoting endorphin release. Although previous nursing studies have demonstrated their benefits in various clinical settings, evidence regarding their use in patients receiving Non-invasive mechanical ventilation is limited. To date, only one study has evaluated stress ball use in patients with chronic obstructive pulmonary disease receiving Non-invasive mechanical ventilation, focusing on pain and anxiety without assessing treatment duration or mask adherence. This study aims to evaluate the effects of stress ball use on treatment duration, anxiety, and mask adherence in patients receiving Non-invasive mechanical ventilation.
Detailed description
Non-invasive mechanical ventilation is the first-line ventilatory support modality for treating acute respiratory failure in patients hospitalized with type II respiratory failure. However, pain, anxiety, and impaired patient comfort experienced during treatment are among the principal factors affecting adherence to Non-invasive mechanical ventilation. These factors may shorten the duration of therapy, reduce mask tolerance, and increase pain associated with mask-related pressure.
In recent years, distraction techniques have been increasingly employed to alleviate treatment-related discomfort. One such method is the use of a stress ball. Rhythmic squeezing of the stress ball in the palm provides physical stimulation of muscles and peripheral nerve endings, thereby redirecting the patient's attention away from unpleasant stimuli. This mechanism is thought to produce an acupuncture-like effect, eliciting an analgesic response and reducing pain perception. Furthermore, stress ball use has been reported to stimulate endorphin release, contributing to reductions in anxiety, pain, and stress.
Recent nursing research has demonstrated the widespread use of stress balls as a distraction technique across patients of all age groups, particularly among individuals undergoing oncology treatments, haemodialysis, and minor surgical procedures in paediatric settings. To date, only one study has been identified that evaluated the effects of stress ball use on pain and anxiety in patients receiving Non-invasive mechanical ventilation. In Şeker's study, the intervention was applied to patients with chronic obstructive pulmonary disease; however, its effects on treatment duration and mask adherence were not investigated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, self-controlled study
| Arm | Type | Receives |
|---|---|---|
| Without stress ball | No intervention | –Patients were observed throughout the 2-hour treatment session without using a stress ball |
| With stress ball | Experimental | Other: With stress ballPatients were observed throughout the 2-hour treatment session with using a stress ball |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physician-confirmed diagnosis of type II respiratory failure.
- Receiving non-invasive mechanical ventilation support for at least 8 hours.
- Receiving non-invasive mechanical ventilation mode.
- Awake and able to communicate between 08:00 and 24:00.
- Aged 18 years or older.
Key exclusion criteria (7 listed)
- Presence of delirium, active psychosis, neurological deficits, cognitive impairment, or any condition that precludes effective communication.
- Presence of infection, wounds, burns, casts, traction devices, amputation, or any other condition affecting the hands or upper extremities that would prevent squeezing a stress ball.
- Hemodynamic instability during non-invasive mechanical ventilation treatment.
- Sleeping during non-invasive mechanical ventilation treatment.
- Requirement for endotracheal intubation during the study period.
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 |
|---|---|---|
| With stress ballParticipants were instructed to continuously squeeze the stress ball during the 2-hour treatment period | Other | With stress ball |
Primary outcome
Change From Baseline Treatment Time
Time frame: Up to 2 hours
The total duration (in minutes) of non-invazive mechanical ventilation received by each patient during two consecutive treatment periods will be recorded.
Change From Baseline Anxiety
Time frame: Up to 2 hours
The Faces Anxiety Scale is a self-report instrument used to assess patients' anxiety levels. Patients evaluate their own anxiety by selecting the facial expression that best reflects how they feel. The scale, measuring 11 × 42 cm, consists of five facial expressions arranged from left to right. The leftmost face represents the absence of anxiety, whereas the level of anxiety increases progressively toward the right. The scale is scored from 0 to 5, with a score of ≥3 indicating moderate to high levels of anxiety. The Faces Anxiety Scale assessments will be performed by a nurse who is independent of the study. Before data collection, the researcher will provide standardized training on the administration of the scale. Following an explanation and demonstration of the assessment procedure using two patients, the nurse will independently assess anxiety in two additional patients under the researcher's supervision. Any deficiencies or inaccuracies in the assessment process will be
1 secondary outcome
Mask adherence
Time frame: Up to 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Results publication: PubMed 28440124Smith TA, Disler RT, Jenkins CR, Ingham JM, Davidson PM. Perspectives on advance care planning among patients recently requiring non-invasive ventilation for acute respiratory failure: A qualitative study using thematic analysis. Palliat Med. 2017 Jun;31(6):566-574. doi: 10.1177/0269216316670286. Epub 2016 Oct 25.
- Results publication: PubMed 24028684Sorensen D, Frederiksen K, Groefte T, Lomborg K. Striving for habitual well-being in noninvasive ventilation: a grounded theory study of chronic obstructive pulmonary disease patients with acute respiratory failure. J Clin Nurs. 2014 Jun;23(11-12):1726-35. doi: 10.1111/jocn.12322. Epub 2013 Sep 13.
- Results publication: PubMed 37599749Volpato E, Banfi PI, Pagnini F. Acceptance and adherence to non-invasive positive pressure ventilation in people with chronic obstructive pulmonary disease: a grounded theory study. Front Psychol. 2023 Aug 3;14:1134718. doi: 10.3389/fpsyg.2023.1134718. eCollection 2023.
- Results publication: PubMed 27401047Iyigun E, Pazar B, Tastan S. A study on reliability and validity of the Turkish version of the Face Anxiety Scale on mechanically-ventilated patients. Intensive Crit Care Nurs. 2016 Dec;37:46-51. doi: 10.1016/j.iccn.2016.05.002. Epub 2016 Jul 9.
- Individual participant dataSharing planned: No
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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.
NURTEN ÖZEN study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With stress ball in people with Non Invasive Ventilation (NIV), run by Istanbul 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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change From Baseline Treatment Time (time frame: Up to 2 hours). 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?
On the ClinicalTrials.gov record for NCT07752004, which also lists 4 linked publications.
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 7 Aug 2026.