PainNCT07880496
The Effect of ShotBlocker on Symptoms of Pain, Anxiety, and Cortisol Hormone Levels
A study testing Intervention Group in people with Pain and Anxiety, run by Ataturk University.
Trial summary
The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 20 Nov 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 conscious, oriented, and cooperative;
- Being able to speak and understand Turkish;
- Having no psychiatric disorder;
- Being an elective patient undergoing lumbar puncture for the first time;
- Being aged 18 years or older;
- Not having received analgesics or sedatives within 2 hours before the procedure; and
- Voluntarily agreeing to participate in the study.
Who cannot join
- Patients with past or current cognitive and psychological disorders,
- Those who have previously undergone lumbar puncture,
- Those who are mechanically ventilated (intubated),
- Those who have chronic pain and routinely use painkillers,
- Those who are not willing to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Shotblockers on Pain, Anxiety, and Cortisol Level Symptoms During Lumbar Puncture: A Randomized Controlled Study
The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.
Read the detailed description
Lumbar puncture is an invasive procedure that can cause pain, anxiety, and a physiological stress response in patients during the procedure. This stress response is associated with an increase in cortisol levels and can negatively affect patient comfort.
While pharmacological methods are used to control pain and anxiety associated with invasive procedures, these methods have disadvantages such as sedation, risk of side effects, prolonged post-procedure recovery time, and additional costs. Therefore, research into safe, easily applicable, and side-effect-free non-pharmacological methods is gaining importance.
Shotblockers are a safe and non-invasive method aimed at reducing pain perception through mechanical pressure. Although their effect on injection pain has been demonstrated in the literature, randomized controlled trials examining their combined effect on pain, anxiety, and cortisol levels during lumbar puncture are limited. Furthermore, research using cortisol levels as a physiological stress indicator is insufficient. This randomized controlled trial aims to evaluate the effect of shotblocker use during lumbar puncture on patients' perceived pain and anxiety levels, as well as on cortisol levels, a biochemical stress indicator. The study aims to reduce selection bias between groups and increase the scientific validity of the results by using a randomization method. The combined use of subjective measurements (pain and anxiety scales) and objective measurements (cortisol levels) will strengthen the reliability of the data obtained. It is anticipated that this research will contribute to evidence-based practices aimed at improving patient comfort in lumbar puncture procedures, support the integration of non-pharmacological interventions into clinical practice, and help improve the quality of patient care.
- Being tested
- Intervention Group, Control
- Keywords
- Lumbar puncture, Shotbloker, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Patients will receive routine monitoring, pharmacological treatment, and nursing care. Under aseptic precautions, lumbar puncture will be performed in all groups using a 25-gauge Quincke spinal needle at the L3-L4 or L4-L5 intervertebral space, with patients in the lateral position. In the ShotBlocker group, after skin preparation and draping, the sterilized ShotBlocker will be placed at the puncture site and firmly pressed for 10 seconds with the non-dominant hand. The spinal needle will then pass through its slit. Methylprednisolone and bupivacaine hydrochloride will be administered into the epidural space. Saliva samples will be collected before and after the procedure for cortisol measurement. Pain and anxiety will be assessed before and 10 minutes after lumbar puncture. The procedure will be performed by the same physician in all groups.
ControlOther
In our research, the "Personal Information Form" will be applied to the control group patients without any intervention other than the clinical protocol. "Visual Analog Scale" and "State Anxiety Scale" will be applied to the patients 10 minutes before the lumbar puncture procedure. Saliva samples will be collected from patients before and after the lumbar puncture, and the collected samples will be stored under appropriate laboratory conditions for measurement of cortisol level. 10 minutes after the procedure is completed, the pain and anxiety levels experienced will be re-evaluated with scales.
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker Group | Experimental | Patients in the intervention group were informed about the lumbar puncture procedure, and the ShotBlocker device was applied during the procedure. Receives: Other: Intervention Group |
| Standard Care Group | Placebo comparator | Patients in the control group received standard care and treatment during the lumbar puncture procedure. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form, created by the researcher, contains a total of 8 questions covering the patients' age, gender, education level, marital status, height/weight, body mass index, and questions about their illness.
Measured: At baseline, before the intervention
Visual Analog Scale
This scale ranges from 0, indicating "No pain," to 10, indicating "Unbearable pain." The patient is asked to rate the intensity of pain on a scale from 0 to 10. The selected value represents the patient's pain score.
Measured: 10 minutes before and 10 minutes after the lumbar puncture procedure
State Anxiety Scale
The State-Trait Anxiety Inventory (STAI) assesses anxiety in individuals aged 14 years and older. The 20-item State Anxiety Inventory used in this study is a 4-point Likert scale: "not at all" (1), "somewhat" (2), "moderately so" (3), and "very much so" (4). Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse-scored (1=4, 2=3, 3=2, 4=1). Scores are summed according to the scoring procedure, with a constant value of 50 added to obtain the final anxiety score. Total scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: 10 minutes before and 10 minutes after the lumbar puncture procedure
Salivary Cortisol Level
Salivary cortisol levels will be measured using commercially available kits with the ELISA method.
Measured: 10 minutes before and 30 minutes after the lumbar puncture procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion20 Oct 2026
- Study completion20 Nov 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.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HARUN ÜNAL, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880496
- Sponsor's protocol ID
- 2026
- Status last verified
- Nov 2026
- First submitted
- 13 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside the study team due to participant confidentiality and data privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shotblockers on Pain, Anxiety, and Cortisol Level Symptoms During Lumbar Puncture: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07880496
- Acronym / sponsor ID
- 2026
- Keywords
- Lumbar puncture, Shotbloker, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 19 Oct 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.
The aim of this study is to evaluate the effect of Shotblocker, administered during lumbar puncture, on patients' pain levels, anxiety levels, and cortisol levels (a physiological stress indicator). This randomized controlled trial aims to scientifically demonstrate the effectiveness of Shotblocker use in reducing pain and anxiety during and after the procedure, and its effect on the stress response, compared to standard practice.
Detailed description
Lumbar puncture is an invasive procedure that can cause pain, anxiety, and a physiological stress response in patients during the procedure. This stress response is associated with an increase in cortisol levels and can negatively affect patient comfort.
While pharmacological methods are used to control pain and anxiety associated with invasive procedures, these methods have disadvantages such as sedation, risk of side effects, prolonged post-procedure recovery time, and additional costs. Therefore, research into safe, easily applicable, and side-effect-free non-pharmacological methods is gaining importance.
Shotblockers are a safe and non-invasive method aimed at reducing pain perception through mechanical pressure. Although their effect on injection pain has been demonstrated in the literature, randomized controlled trials examining their combined effect on pain, anxiety, and cortisol levels during lumbar puncture are limited. Furthermore, research using cortisol levels as a physiological stress indicator is insufficient. This randomized controlled trial aims to evaluate the effect of shotblocker use during lumbar puncture on patients' perceived pain and anxiety levels, as well as on cortisol levels, a biochemical stress indicator. The study aims to reduce selection bias between groups and increase the scientific validity of the results by using a randomization method. The combined use of subjective measurements (pain and anxiety scales) and objective measurements (cortisol levels) will strengthen the reliability of the data obtained. It is anticipated that this research will contribute to evidence-based practices aimed at improving patient comfort in lumbar puncture procedures, support the integration of non-pharmacological interventions into clinical practice, and help improve the quality of patient care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Group | Experimental | Other: Intervention GroupPatients in the intervention group were informed about the lumbar puncture procedure, and the ShotBlocker device was applied during the procedure. |
| Standard Care Group | Placebo comparator | Other: ControlPatients in the control group received standard care and treatment during the lumbar puncture procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being conscious, oriented, and cooperative;
- Being able to speak and understand Turkish;
- Having no psychiatric disorder;
- Being an elective patient undergoing lumbar puncture for the first time;
- Being aged 18 years or older;
Key exclusion criteria (5 listed)
- Patients with past or current cognitive and psychological disorders,
- Those who have previously undergone lumbar puncture,
- Those who are mechanically ventilated (intubated),
- Those who have chronic pain and routinely use painkillers,
- Those who are not willing to participate in 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 |
|---|---|---|
| Intervention GroupPatients will receive routine monitoring, pharmacological treatment, and nursing care. Under aseptic precautions, lumbar puncture will be performed in all groups using a 25-gauge Quincke spinal needle at the L3-L4 or L4-L5 intervertebral space, with patients in the lateral position. In the ShotBlocker group, after skin preparation and draping, the sterilized ShotBlocker will be placed at the puncture site and firmly pressed for 10 seconds with the non-dominant hand. The spinal needle will then pass through its slit. Methylprednisolone and bupivacaine hydrochloride will be administered into the epidural space. Saliva samples will be collected before and after the procedure for cortisol measurement. Pain and anxiety will be assessed before and 10 minutes after lumbar puncture. The procedure will be performed by the same physician in all groups. | Other | ShotBlocker Group |
| ControlIn our research, the "Personal Information Form" will be applied to the control group patients without any intervention other than the clinical protocol. "Visual Analog Scale" and "State Anxiety Scale" will be applied to the patients 10 minutes before the lumbar puncture procedure. Saliva samples will be collected from patients before and after the lumbar puncture, and the collected samples will be stored under appropriate laboratory conditions for measurement of cortisol level. 10 minutes after the procedure is completed, the pain and anxiety levels experienced will be re-evaluated with scales. | Other | Standard Care Group |
Primary outcome
Personal Information Form
Time frame: At baseline, before the intervention
This form, created by the researcher, contains a total of 8 questions covering the patients' age, gender, education level, marital status, height/weight, body mass index, and questions about their illness.
Visual Analog Scale
Time frame: 10 minutes before and 10 minutes after the lumbar puncture procedure
This scale ranges from 0, indicating "No pain," to 10, indicating "Unbearable pain." The patient is asked to rate the intensity of pain on a scale from 0 to 10. The selected value represents the patient's pain score.
State Anxiety Scale
Time frame: 10 minutes before and 10 minutes after the lumbar puncture procedure
The State-Trait Anxiety Inventory (STAI) assesses anxiety in individuals aged 14 years and older. The 20-item State Anxiety Inventory used in this study is a 4-point Likert scale: "not at all" (1), "somewhat" (2), "moderately so" (3), and "very much so" (4). Items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20 are reverse-scored (1=4, 2=3, 3=2, 4=1). Scores are summed according to the scoring procedure, with a constant value of 50 added to obtain the final anxiety score. Total scores range from 20 to 80, with higher scores indicating greater anxiety.
Salivary Cortisol Level
Time frame: 10 minutes before and 30 minutes after the lumbar puncture procedure
Salivary cortisol levels will be measured using commercially available kits with the ELISA method.
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 3 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside the study team due to participant confidentiality and data privacy considerations.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Pain and Anxiety, run by Ataturk University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Harun Ünal, Dr (+905338690207, harun_unal65@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: At baseline, before the intervention). The study lists 4 primary outcomes in all. 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 3 Nov 2026.