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NCT Number: NCT07836842

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

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.

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Key information

Conditions

Procedural Pain Anxiety Disorders Critical Illness Disease Attributes Mental Disorders Neurologic Manifestations Pain Pain, Procedural Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. State anxiety during the painful procedure

    Time frame: 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.

  2. Patient satisfaction with the procedure and pain management

    Time frame: 15 minutes after the painful procedure

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

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Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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