Stress-Ball Distraction for Pain and Anxiety During Painful Procedures in Critically Ill Patients

NCT07836842 | Not Yet Recruiting DMC

• 1 other identifier: Au-20-2-417
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Procedural Pain

Keywords

procedural pain; Critical illness; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  During the painful procedure

Secondary Outcomes (7)

• 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)

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Participants will receive the usual standard care provided during the painful procedure, without stress-ball distraction.

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.

Other: Stress-Ball Distraction

Interventions

Stress-Ball Distraction OTHER

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.

Stress-Ball Distraction

Standard care OTHER

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment preventing reliable self-report.
• Severe hand injury or neuromuscular disorder.
• Hemodynamic instability.
• Allergy to stress-ball materials.

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Pain, Procedural; Critical Illness; Anxiety Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 23, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share