The Effect of a Stress Ball During Oral Care Procedures

NCT07676422 | Recruiting

• 1 other identifier: stress ball - oral care
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Stress

Keywords

Stress ball; Oral Care Procedures

Outcome Measures

Primary Outcomes (1)

• Stress level

  A distress thermometer will determine the stress level using numbers from 0 to 10 on its scale.

  periprocedural

Secondary Outcomes (1)

• Pain level

  periprocedural

Study Arms (2)

Stress ball group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Stress ball OTHER

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.

Stress ball group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Sbu. Van Training and Research Hospital

Van, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cansu Koyunoğlu, Asst. Prof

  Erzurum Technical University

  STUDY CHAIR

Central Study Contacts

Yavuz Uren, Asst. Prof

CONTACT

+905065961050; yavuzuren@yyu.edu.tr

Cansu Koyunoğlu, Asst. Prof

CONTACT

+905379652960; bedriye.koyunoglu@erzurum.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and Outcomes Assessor will not know the experimental and control groups during the data collection and evaluation phases. The groups will be coded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: in a double-blind randomized controlled experimental design

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 25, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

TU (1)