The Effect of a Stress Ball During Oral Care Procedures

June 29, 2026 updated by: Yavuz Uren, Yuzuncu Yil University

The Effect of a Stress Ball on Pain, Anxiety, and Stress During Oral Care Procedures: A Randomized Controlled Experimental Study

This study aims to evaluate the effect of using stress balls during oral care procedures performed on conscious patients in the intensive care unit on patients' pain, anxiety, and stress levels.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the effect of using a stress ball during oral care procedures on pain, anxiety, and stress levels in conscious patients in the intensive care unit. Individuals meeting the inclusion criteria and voluntarily agreeing to participate in the study were randomly assigned to groups. Pre-test forms will be administered. The stress ball group will be given a stress ball by the researcher before oral care and will be asked to focus on and squeeze the ball for 15-20 minutes during oral care. The control group will continue with routine treatment and care; no additional intervention will be applied. Post-test measurements will be evaluated after oral care.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Van, Turkey (Türkiye)
        • Recruiting
        • Sbu. Van Training and Research Hospital
        • Contact:
          • Hayrullah Şavlı
          • Phone Number: +905308981365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being 18 years of age or older,
  • Being conscious and able to communicate,
  • Having an indication for oral care application,
  • Agreeing to participate in the study voluntarily.

Exclusion Criteria:

  • Being under heavy sedation,
  • Those with limited upper extremity movement,
  • Those with severe neurological disorders,
  • Having any problem with squeezing a ball in their hand (wound, fracture, weakness)

Termination Criteria:

  • Those who wish to withdraw from the study,
  • Those who change institutions/city,
  • The study will be terminated in the event of the patient's death.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress ball group
The stress ball group will be given a stress ball by the researcher before oral care and asked to focus on and squeeze the ball for 15-20 minutes during oral care.
Other: Stress ball
The stress ball group will be given a stress ball by the researcher before oral care and asked to focus on and squeeze the ball for 15-20 minutes during oral care.
No Intervention: Control group
The control group will continue with routine treatment and care; no additional intervention will be applied. Final test measurements will be evaluated after oral care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress level
Time Frame: periprocedural
A distress thermometer will determine the stress level using numbers from 0 to 10 on its scale.
periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: periprocedural
Pain level will be determined using the numbers 0 through 10 on the Visual Analog Scale.
periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yil University

Investigators

  • Study Chair: Cansu Koyunoğlu, Asst. Prof, Erzurum Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

August 25, 2026

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 29, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • stress ball - oral care

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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