PainNCT07676422
The Effect of a Stress Ball During Oral Care Procedures
A study testing Stress ball in people with Pain and Stress, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Stress ball
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2026to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sbu. Van Training and Research Hospital
Van
Hayrullah Şavlı, +905308981365
About this study
Official title: 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.
Read the 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.
- Being tested
- Stress ball
- Keywords
- Stress ball, Oral Care Procedures
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level
A distress thermometer will determine the stress level using numbers from 0 to 10 on its scale.
Measured: periprocedural
Secondary outcomes (1)
Pain level
Pain level will be determined using the numbers 0 through 10 on the Visual Analog Scale.
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start25 May 2026
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- in a double-blind randomized controlled experimental design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Uren, Yuzuncu Yil University
- Investigators
- Cansu Koyunoğlu, Asst. Prof, Study chair, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676422
- Sponsor's protocol ID
- stress ball - oral care
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Stress Ball on Pain, Anxiety, and Stress During Oral Care Procedures: A Randomized Controlled Experimental Study
- ClinicalTrials.gov ID
- NCT07676422
- Acronym / sponsor ID
- stress ball - oral care
- Keywords
- Stress ball, Oral Care Procedures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- in a double-blind randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| Stress ball group | Experimental | Other: Stress ballThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
- Those who wish to withdraw from the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ballThe 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 group |
Primary outcome
Stress level
Time frame: periprocedural
A distress thermometer will determine the stress level using numbers from 0 to 10 on its scale.
1 secondary outcome
Pain level
Time frame: periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cansu Koyunoğlu, Asst. Prof study chair
Erzurum Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball in people with Pain and Stress, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yavuz Uren, Asst. Prof (+905065961050, yavuzuren@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress level (time frame: periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.