An interventional study of Stress-Ball Distraction and Standard care in Procedural Pain, sponsored by Alexandria University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
This study's planned enrollment of 104 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Browse Pain, Procedural studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the usual standard care provided during the painful procedure, without stress-ball distraction.
Other: Standard care
Participants will receive standard care during the painful procedure and will use a hand-held stress ball as a distraction technique.
Other: Stress-Ball Distraction
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.
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.
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.
Time frame: During the painful procedure
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
Time frame: Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 2 months later.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 2 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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