Procedural PainNCT07836842
Stress-Ball Distraction for Pain and Anxiety During Painful Procedures in Critically Ill Patients
A study testing Stress-Ball Distraction in people with Procedural Pain, run by Alexandria University.
Trial summary
This study will examine whether using a small hand-held stress ball during painful procedures can help critically ill adult patients feel less pain and anxiety. Painful procedures may also temporarily increase heart rate, blood pressure, and breathing rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Stress-Ball Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 1 Jan 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
- Adults aged ≥18 years admitted to the critical care unit.
- Patients scheduled for a painful procedure, including arterial puncture, venipuncture, tracheal suctioning, repositioning, or dressing change.
- Patients able to provide informed consent.
- Patients able to use the pain and anxiety rating scales.
Who cannot join
- Cognitive impairment preventing reliable self-report.
- Severe hand injury or neuromuscular disorder.
- Hemodynamic instability.
- Allergy to stress-ball materials.
About this study
Official title: The Effect of Stress-Ball Distraction on Pain, Anxiety, Physiologic Responses, and Satisfaction During Painful Procedures in Critically Ill Patients: A Randomized Controlled Trial
This study will examine whether using a small hand-held stress ball during painful procedures can help critically ill adult patients feel less pain and anxiety. Painful procedures may also temporarily increase heart rate, blood pressure, and breathing rate.
Participants will be randomly assigned, like flipping a coin, to one of two groups. One group will receive usual care during the procedure. The other group will receive usual care and will be asked to squeeze a stress ball as a distraction technique during the procedure.
The study team will measure participants' pain and anxiety before, during, and 15 minutes after the procedure. The team will also record heart rate, blood pressure, respiratory rate, oxygen saturation, procedure-related events, use of additional pain medicine or sedation, and satisfaction with care. The findings may help health care providers understand whether stress-ball distraction is a safe, simple, non-drug method for improving comfort during painful procedures in critically ill patients.
- Conditions
- Procedural Pain
- Being tested
- Stress-Ball Distraction, Standard care
- Keywords
- procedural pain, Critical illness, Anxiety
- Medical subject headings
- Pain, Procedural, Critical Illness, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress-Ball DistractionOther
Participants assigned to the experimental arm will use a hand-held stress ball as a non-pharmacological distraction technique during the painful procedure, in addition to receiving standard care.
Standard careOther
Participants will receive the routine standard care provided during the painful procedure according to the unit's usual clinical practice. No stress-ball distraction technique will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Participants will receive the usual standard care provided during the painful procedure, without stress-ball distraction. Receives: Other: Standard care |
| Stress-Ball Distraction | Experimental | Participants will receive standard care during the painful procedure and will use a hand-held stress ball as a distraction technique. Receives: Other: Stress-Ball Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak procedural pain intensity
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. The peak pain score recorded during the painful procedure will be compared between the stress-ball distraction and standard-care groups.
Measured: During the painful procedure
Secondary outcomes (7)
State anxiety during the painful procedure
State anxiety will be assessed using the six-item State-Trait Anxiety Inventory (STAI-6). Each item is scored from 1 to 4, with total scores ranging from 6 to 24; higher scores indicate greater anxiety. Anxiety will be compared between the stress-ball distraction group and the usual-care control group.
Measured: During the painful procedure
Patient satisfaction with the procedure and pain management
Patient satisfaction will be assessed using a 5-point Likert satisfaction scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction with pain management and the overall procedural experience.
Measured: 15 minutes after the painful procedure
Heart rate during and after the painful procedure
Heart rate (beats per minute) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.
Measured: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Systolic blood pressure during and after the painful procedure
Systolic blood pressure (mmHg) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.
Measured: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Diastolic blood pressure during and after the painful procedure
Diastolic blood pressure (mmHg) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.
Measured: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Respiratory rate during and after the painful procedure
Respiratory rate (breaths per minute) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.
Measured: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Peripheral oxygen saturation (SpO₂) during and after the painful procedure
Peripheral oxygen saturation (SpO₂, %) will be recorded at baseline before the procedure, during the procedure, and 15 minutes after the procedure. Changes and recovery will be compared between the stress-ball distraction group and the usual-care control group.
Measured: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836842
- Sponsor's protocol ID
- Au-20-2-417
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress-Ball Distraction on Pain, Anxiety, Physiologic Responses, and Satisfaction During Painful Procedures in Critically Ill Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07836842
- Acronym / sponsor ID
- Au-20-2-417
- Conditions
- Procedural Pain
- Keywords
- procedural pain, Critical illness, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Sep 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.
This study will examine whether using a small hand-held stress ball during painful procedures can help critically ill adult patients feel less pain and anxiety. Painful procedures may also temporarily increase heart rate, blood pressure, and breathing rate.
Participants will be randomly assigned, like flipping a coin, to one of two groups. One group will receive usual care during the procedure. The other group will receive usual care and will be asked to squeeze a stress ball as a distraction technique during the procedure.
The study team will measure participants' pain and anxiety before, during, and 15 minutes after the procedure. The team will also record heart rate, blood pressure, respiratory rate, oxygen saturation, procedure-related events, use of additional pain medicine or sedation, and satisfaction with care. The findings may help health care providers understand whether stress-ball distraction is a safe, simple, non-drug method for improving comfort during painful procedures in critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard careParticipants will receive the usual standard care provided during the painful procedure, without stress-ball distraction. |
| Stress-Ball Distraction | Experimental | Other: Stress-Ball DistractionParticipants will receive standard care during the painful procedure and will use a hand-held stress ball as a distraction technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years admitted to the critical care unit.
- Patients scheduled for a painful procedure, including arterial puncture, venipuncture, tracheal suctioning, repositioning, or dressing change.
- Patients able to provide informed consent.
- Patients able to use the pain and anxiety rating scales.
Key exclusion criteria (4 listed)
- Cognitive impairment preventing reliable self-report.
- Severe hand injury or neuromuscular disorder.
- Hemodynamic instability.
- Allergy to stress-ball materials.
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-Ball DistractionParticipants assigned to the experimental arm will use a hand-held stress ball as a non-pharmacological distraction technique during the painful procedure, in addition to receiving standard care. | Other | Stress-Ball Distraction |
| Standard careParticipants will receive the routine standard care provided during the painful procedure according to the unit's usual clinical practice. No stress-ball distraction technique will be provided. | Other | Standard care |
Primary outcome
Peak procedural pain intensity
Time frame: During the painful procedure
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. The peak pain score recorded during the painful procedure will be compared between the stress-ball distraction and standard-care groups.
7 secondary outcomes
State anxiety during the painful procedure
Time frame: During the painful procedure
Patient satisfaction with the procedure and pain management
Time frame: 15 minutes after the painful procedure
Heart rate during and after the painful procedure
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Systolic blood pressure during and after the painful procedure
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Diastolic blood pressure during and after the painful procedure
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Respiratory rate during and after the painful procedure
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
Peripheral oxygen saturation (SpO₂) during and after the painful procedure
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
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 23 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stress-Ball Distraction in people with Procedural Pain, run by Alexandria University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak procedural pain intensity (time frame: During the painful procedure). 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 23 Sep 2026.