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Squeeze away anxiety: could a simple stress ball boost ventilation treatment success?

NCT ID NCT07752004

Symptom relief Sponsor: Istanbul University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether using a stress ball during non-invasive ventilation (NIV) can reduce anxiety, extend treatment time, and improve mask adherence in patients with type II respiratory failure. Participants will squeeze a stress ball continuously during their 2-hour treatment sessions, and researchers will measure changes in anxiety levels, total ventilation duration, and how well patients tolerate the mask. The goal is to see if this simple, drug-free distraction technique can make NIV more comfortable and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stress ball
What this could lead to
If effective, stress balls could become a simple, low-cost way to reduce anxiety and improve comfort and treatment adherence for patients on non-invasive ventilation.
What could go wrong
This is a small, early-stage trial with only 50 participants, so results may not apply broadly. The distraction effect might be too mild to meaningfully change anxiety or treatment duration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non invasive ventilation (NIV)

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Istanbul University

    Istanbul, Turkey (Türkiye)

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