Neurologic DisorderNCT06146543
Stress Ball During Lumbar Puncture the Effect of the Application on Anxiety Level
A study testing Stress ball in people with Neurologic Disorder, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Individuals who come to the neurology clinic to undergo lumbar puncture, and meet the inclusion criteria, and agree to participate in the study will be given a stress ball during the procedure and will be asked to squeeze this ball. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 over 18 years old
- Volunteering to participate in the study
- Being able to read and write
- No problems in verbal communication
- Lumbar puncture procedure will be performed
Who cannot join
- - Do not come to the neurology clinic for any procedure other than lumbar puncture.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul
About this study
Official title: Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level
Individuals who come to the neurology clinic to undergo lumbar puncture, and meet the inclusion criteria, and agree to participate in the study will be given a stress ball during the procedure and will be asked to squeeze this ball.
Read the detailed description
Before starting the research, the purpose of the research will be explained to patients who meet the inclusion and exclusion criteria, and their verbal and written consent will be obtained. The Declaration of Helsinki will be adhered to throughout the research. Data will be obtained by administering face-to-face surveys. The population of the study will be individuals who meet the inclusion criteria at the neurology clinic of Istanbul University - Istanbul Faculty of Medicine, and the individuals who agree to participate in the study will constitute the sample. To determine the number of samples, a comparison of two groups was made using the "G-Power 3.1.7" program. The minimum sample size that would provide Type I margin of error (α): 0.05 and power of the test (1-β): 0.80 was determined as 47 people per group. Taking into account sample loss, it was aimed to reach a total of 100 people.
Then, the form questioning socio-demographic information and the STAI XT State-Trait Anxiety Scale will be applied. Before the LP begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she will be asked to squeeze this ball slowly throughout the process. At the end of the procedure, the ball will be removed from his hand and the patient will be relieved. After the patient is relaxed, the STAI XT State-Trait Anxiety Scale will be administered again.
The state anxiety scale is a sensitive scale for evaluating sudden changes in emotional reactions. The trait anxiety scale aims to measure the continuity of anxiety that a person generally tends to experience. Since this study aims to evaluate the anxiety levels of patients regarding their current situations, the state anxiety scale will be used.
- Conditions
- Neurologic Disorder
- Being tested
- Stress ball
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
Before the procedure begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she will be asked to squeeze this ball slowly throughout the process. At the end of the procedure, the ball will be removed from his hand and the patient will be relieved.
| Study group | Role | What they receive |
|---|---|---|
| neurology patients | Experimental | Patients coming to the neurology clinic for lumbar puncture. Receives: Other: Stress ball |
| Control | No intervention | The scale will be applied to the same patient group before and after lumbar puncture without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI XT-1 State-Trait Anxiety Scale
It will be used to evaluate the current state of anxiety. The scale has a total of 40 items, 20 of which measure state anxiety and 20 measure trait anxiety. In order to determine the behaviors and emotions of the individuals to whom the scale is applied, each item is evaluated with the options of 'not at all', 'somewhat', 'a lot', and 'completely'. An increase in the total score obtained from the scale indicates that the person's anxiety level is increasing.
When the patient comes to the clinic, he/she will be informed about the study his/her consent will be obtained, and then the scale will be filled out.
Measured: up to 6 months
Secondary outcomes (1)
STAI XT-1 State-Trait Anxiety Scale
It will be used to evaluate the immediate anxiety state after the intervention. The scale has a total of 40 items, 20 of which measure state anxiety and 20 measure trait anxiety. In order to determine the behaviors and emotions of the individuals to whom the scale is applied, each item is evaluated with the options of 'not at all', 'somewhat', 'a lot', and 'completely'. An increase in the total score obtained from the scale indicates that the person's anxiety level is increasing.
After the lumbar puncture procedure is completed, the patient will be relieved by taking the ball from her hand and the scale will be filled.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Oct 2023
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Baykal, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146543
- Sponsor's protocol ID
- 2135111
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Ball During Lumbar Puncture in Neurological Patients the Effect of the Application on Anxiety Level
- ClinicalTrials.gov ID
- NCT06146543
- Acronym / sponsor ID
- 2135111
- Conditions
- Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 24 Nov 2023 (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.
Individuals who come to the neurology clinic to undergo lumbar puncture, and meet the inclusion criteria, and agree to participate in the study will be given a stress ball during the procedure and will be asked to squeeze this ball.
Detailed description
Before starting the research, the purpose of the research will be explained to patients who meet the inclusion and exclusion criteria, and their verbal and written consent will be obtained. The Declaration of Helsinki will be adhered to throughout the research. Data will be obtained by administering face-to-face surveys. The population of the study will be individuals who meet the inclusion criteria at the neurology clinic of Istanbul University - Istanbul Faculty of Medicine, and the individuals who agree to participate in the study will constitute the sample. To determine the number of samples, a comparison of two groups was made using the "G-Power 3.1.7" program. The minimum sample size that would provide Type I margin of error (α): 0.05 and power of the test (1-β): 0.80 was determined as 47 people per group. Taking into account sample loss, it was aimed to reach a total of 100 people.
Then, the form questioning socio-demographic information and the STAI XT State-Trait Anxiety Scale will be applied. Before the LP begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she will be asked to squeeze this ball slowly throughout the process. At the end of the procedure, the ball will be removed from his hand and the patient will be relieved. After the patient is relaxed, the STAI XT State-Trait Anxiety Scale will be administered again.
The state anxiety scale is a sensitive scale for evaluating sudden changes in emotional reactions. The trait anxiety scale aims to measure the continuity of anxiety that a person generally tends to experience. Since this study aims to evaluate the anxiety levels of patients regarding their current situations, the state anxiety scale will be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control group
| Arm | Type | Receives |
|---|---|---|
| neurology patients | Experimental | Other: Stress ballPatients coming to the neurology clinic for lumbar puncture. |
| Control | No intervention | –The scale will be applied to the same patient group before and after lumbar puncture without intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Being over 18 years old
- Volunteering to participate in the study
- Being able to read and write
- No problems in verbal communication
- Lumbar puncture procedure will be performed
Key exclusion criteria (1 listed)
- - Do not come to the neurology clinic for any procedure other than lumbar puncture.
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 ballBefore the procedure begins, the patient's free hand will be given an elastic ball that is large enough to hold in the palm of the hand and squeeze easily. He/she will be asked to squeeze this ball slowly throughout the process. At the end of the procedure, the ball will be removed from his hand and the patient will be relieved. | Other | neurology patients |
Primary outcome
STAI XT-1 State-Trait Anxiety Scale
Time frame: up to 6 months
It will be used to evaluate the current state of anxiety. The scale has a total of 40 items, 20 of which measure state anxiety and 20 measure trait anxiety. In order to determine the behaviors and emotions of the individuals to whom the scale is applied, each item is evaluated with the options of 'not at all', 'somewhat', 'a lot', and 'completely'. An increase in the total score obtained from the scale indicates that the person's anxiety level is increasing. When the patient comes to the clinic, he/she will be informed about the study his/her consent will be obtained, and then the scale will be filled out.
1 secondary outcome
STAI XT-1 State-Trait Anxiety Scale
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurologic Disorder, run by Atlas 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI XT-1 State-Trait Anxiety Scale (time frame: up to 6 months). 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 4 Sep 2026.