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.
Exclusion Criteria:
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
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Alexandria University