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NCT Number: NCT07676422

The Effect of a Stress Ball During Oral Care Procedures

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sbu. Van Training and Research Hospital

Van, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hayrullah Şavlı

CONTACT

+905308981365

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Stress level

    Time frame: periprocedural

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

Secondary outcomes

  1. Pain level

    Time frame: periprocedural

    Pain level will be determined using the numbers 0 through 10 on the Visual Analog Scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu Koyunoğlu, Asst. Prof

CONTACT

[email protected]

+905379652960

Yavuz Uren, Asst. Prof

CONTACT

[email protected]

+905065961050

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 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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