The Effect of Stress-Ball Distraction on Pain, Anxiety, Physiologic Responses, and Satisfaction During Painful Procedures in Critically Ill Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Alexandria University
- Enrollment
- 104
- Primary Endpoint
- Peak procedural pain intensity
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Cognitive impairment preventing reliable self-report.
- •Severe hand injury or neuromuscular disorder.
- •Hemodynamic instability.
- •Allergy to stress-ball materials.
Arms & Interventions
Standard care
Participants will receive the usual standard care provided during the painful procedure, without stress-ball distraction.
Intervention: Standard care (Other)
Stress-Ball Distraction
Participants will receive standard care during the painful procedure and will use a hand-held stress ball as a distraction technique.
Intervention: Stress-Ball Distraction (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- State anxiety during the painful procedure(During the painful procedure)
- Patient satisfaction with the procedure and pain management(15 minutes after the painful procedure)
- Heart rate during and after the painful procedure(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(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(Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2))
- Respiratory rate during and after the painful procedure(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(Baseline before the procedure (T0), during the procedure (T1), and 15 minutes after the procedure (T2))