AnxietyNCT07300618
Stress Ball and Music to Reduce Anxiety and Pain in Platelet Apheresis
A study testing müzik resital, stres topu and aferez makinesi in people with Anxiety and Stress, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a single-center, prospective, randomized controlled trial to investigate the effects of stress ball use-a distraction and attention-directing method-and music listening, which targets the auditory sensory pathway, on anxiety, stress, and pain levels in platelet apheresis donors beyond… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- müzik resital, stres topu and aferez makinesi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Dec 2025
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Donors who:
- Were literate in Turkish
- Had no physical limitations preventing them from squeezing a stress ball
- Had no psychiatric disorders or visual, auditory, or perceptual impairments
- Met the institution's platelet apheresis donation criteria
- Were donating platelets for the first time
- Voluntarily wished to donate platelets
- Agreed to participate in the study
Who cannot join
- Donors who:
- Withdrew from platelet apheresis donation
- Wished to withdraw from the study
- Developed a reaction during the donation
- Had insufficient blood flow through the catheter
- Were unable to complete the platelet apheresis donation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Namık Kemal University
Tekirdağ, Süleymanpaşa, 59100
About this study
Official title: The Effect of Stress Ball And Music on Anxiety, Stress, and Pain Levels During Platelet Apheresis Donation: Randomized Controlled Trial
This study was conducted as a single-center, prospective, randomized controlled trial to investigate the effects of stress ball use-a distraction and attention-directing method-and music listening, which targets the auditory sensory pathway, on anxiety, stress, and pain levels in platelet apheresis donors beyond routine care. The study sample consisted of 102 donors aged 18 to 55 years who were donating platelets for the first time at a university hospital blood transfusion center. The participants were divided into three groups: 34 in the stress ball group, 34 in the music listening group, and 34 in the control group. Data were collected using the Donor Information Form, the Beck Anxiety Inventory (BAI), the Visual Analogue Scale (VAS) for pain, the Distress Thermometer (DT), and the Donor Follow-up Chart. During platelet apheresis, participants in the stress ball group were instructed to squeeze a stress ball for 30 minutes, those in the music group listened to instrumental music for 30 minutes, and the control group received only routine care without any additional intervention.
Read the detailed description
Data Collection and Evaluation Process Pre-Implementation Phase Before starting the study, a pilot test was conducted with 10% of the individuals representing the study sample to evaluate the understandability and usability of the scales and forms to be used as data collection tools, as well as to assess the feasibility of stress ball and music interventions. Based on the results of the pilot study, necessary revisions were made to the study content, forms, stress ball application, and music intervention, and the final version of the study protocol was created. Data obtained from the pilot study were not included in the main analysis. Implementation Phase Donors who met the inclusion criteria were informed by the researchers about the purpose, design, and method of the study. Written informed consent was obtained from all participants using separate Informed Consent Forms prepared for each group. Stress Ball Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analog Scale (VAS) as a pre-test through face-to-face interviews. Vital signs were recorded on the Donor Monitoring Chart. When the platelet apheresis procedure began, a stress ball was placed in the donor's hand. Participants were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded on the Donor Follow-up Table, indicating that the study procedure was complete.
Music Listening Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analogue Scale (VAS) as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. After the platelet apheresis procedure began, instrumental music composed of Classical Turkish Music modes was played for 30 minutes through the center's speaker system. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study procedure was concluded.
Control Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, BAI, DT, and VAS as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. During the platelet apheresis procedure, no additional intervention was applied to the donors in the control group, and they continued to receive routine care. Five minutes after the procedure was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study was concluded.
Ethical Considerations Ethical approval for the study was obtained from the institutional ethics committee (research protocol number: 2023.03.01.03). Written permission was also obtained from the institution where the study was conducted. The identities of the researchers and the data obtained from the study were kept confidential.
- Being tested
- müzik resital, stres topu, aferez makinesi, antikoagülan çözelti
- Keywords
- Platelet apheresis, Anxiety, Stress, Nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
müzik resitalOther
After the platelet apheresis procedure began, donors in the music listening group were exposed to instrumental music composed of Classical Turkish Music modes for 30 minutes through the center's speaker system.
stres topuOther
When the platelet apheresis procedure began, a stress ball was placed in the palm of one hand of the donors in the stress ball group. They were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure.
aferez makinesiDevice
Also called Spektral Optik
The platelet apheresis procedure was performed on donors using an apheresis machine.
antikoagülan çözeltiDrug
Also called ACD-A
In accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors.
| Study group | Role | What they receive |
|---|---|---|
| müzik resital | Experimental | During the platelet apheresis donation, instrumental music was played for the participant for 30 minutes. Receives: Other: müzik resital; Device: aferez makinesi; Drug: antikoagülan çözelti |
| stres topu | Experimental | The participant was instructed to squeeze a stress ball for 30 minutes during the platelet apheresis donation. Receives: Other: stres topu; Device: aferez makinesi; Drug: antikoagülan çözelti |
| kontrol grubu | No intervention | Routine treatment and follow-up were continued, and no intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by the Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is a validated, self-reported measure used to assess pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain will be measured immediately before and immediately after the platelet apheresis procedure.
Measured: 30 minutes
Anxiety Levels Measured by the Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) is a 21-item, self-reported questionnaire used to assess the severity of anxiety symptoms. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate higher levels of anxiety. Anxiety will be measured immediately before and immediately after the platelet apheresis procedure in all groups.
Measured: 30 minutes
Stress Levels Measured by the Distress Thermometer (DT)
The Distress Thermometer (DT) is a validated, self-reported screening tool used to assess stress and distress levels. It consists of a single-item visual scale ranging from 0 to 10, where 0 indicates no stress/distress and 10 indicates extreme stress/distress. Higher scores represent higher levels of stress. Stress levels will be measured immediately before and immediately after the platelet apheresis procedure in all groups.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Aug 2024
- Primary completion20 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Urtekin, Saglik Bilimleri Universitesi
- Investigators
- Seval SA Akpınar, Seval a, Study director, namık kemal üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300618
- Sponsor's protocol ID
- 2023.03.01.03
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I prefer not to
Publications
Wen X, Shi J, Tan W, Jiang H, Wang D, Su J, Yang G, Zhang B. Effects of aromatherapy and music therapy on patients' anxiety during MRI examinations: a randomized controlled trial. Eur Radiol. 2023 Apr;33(4):2510-2518. doi: 10.1007/s00330-022-09230-3. Epub 2022 Nov 6.
PubMed 36335480Abdul Hamid MR, Mansor MB, Zainal Abidin MF. Music therapy for reducing anxiety in patients undergoing total knee replacement surgery under subarachnoid anesthesia. J Orthop Surg (Hong Kong). 2022 May-Aug;30(2):10225536221122347. doi: 10.1177/10225536221122347.
PubMed 36031855Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.
PubMed 30027283Duncanson E, Le Leu RK, Shanahan L, Macauley L, Bennett PN, Weichula R, McDonald S, Burke ALJ, Collins KL, Chur-Hansen A, Jesudason S. The prevalence and evidence-based management of needle fear in adults with chronic disease: A scoping review. PLoS One. 2021 Jun 10;16(6):e0253048. doi: 10.1371/journal.pone.0253048. eCollection 2021.
PubMed 34111207Kabacoff RI, Segal DL, Hersen M, Van Hasselt VB. Psychometric properties and diagnostic utility of the Beck Anxiety Inventory and the State-Trait Anxiety Inventory with older adult psychiatric outpatients. J Anxiety Disord. 1997 Jan-Feb;11(1):33-47. doi: 10.1016/s0887-6185(96)00033-3.
PubMed 9131880Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.
PubMed 30280915Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.
PubMed 1437591
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball And Music on Anxiety, Stress, and Pain Levels During Platelet Apheresis Donation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07300618
- Acronym / sponsor ID
- 2023.03.01.03
- Keywords
- Platelet apheresis, Anxiety, Stress, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Dec 2025 (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 was conducted as a single-center, prospective, randomized controlled trial to investigate the effects of stress ball use-a distraction and attention-directing method-and music listening, which targets the auditory sensory pathway, on anxiety, stress, and pain levels in platelet apheresis donors beyond routine care. The study sample consisted of 102 donors aged 18 to 55 years who were donating platelets for the first time at a university hospital blood transfusion center. The participants were divided into three groups: 34 in the stress ball group, 34 in the music listening group, and 34 in the control group. Data were collected using the Donor Information Form, the Beck Anxiety Inventory (BAI), the Visual Analogue Scale (VAS) for pain, the Distress Thermometer (DT), and the Donor Follow-up Chart. During platelet apheresis, participants in the stress ball group were instructed to squeeze a stress ball for 30 minutes, those in the music group listened to instrumental music for 30 minutes, and the control group received only routine care without any additional intervention.
Detailed description
Data Collection and Evaluation Process Pre-Implementation Phase Before starting the study, a pilot test was conducted with 10% of the individuals representing the study sample to evaluate the understandability and usability of the scales and forms to be used as data collection tools, as well as to assess the feasibility of stress ball and music interventions. Based on the results of the pilot study, necessary revisions were made to the study content, forms, stress ball application, and music intervention, and the final version of the study protocol was created. Data obtained from the pilot study were not included in the main analysis. Implementation Phase Donors who met the inclusion criteria were informed by the researchers about the purpose, design, and method of the study. Written informed consent was obtained from all participants using separate Informed Consent Forms prepared for each group. Stress Ball Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analog Scale (VAS) as a pre-test through face-to-face interviews. Vital signs were recorded on the Donor Monitoring Chart. When the platelet apheresis procedure began, a stress ball was placed in the donor's hand. Participants were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded on the Donor Follow-up Table, indicating that the study procedure was complete.
Music Listening Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, Beck Anxiety Inventory (BAI), Distress Thermometer (DT), and Visual Analogue Scale (VAS) as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. After the platelet apheresis procedure began, instrumental music composed of Classical Turkish Music modes was played for 30 minutes through the center's speaker system. Five minutes after the donation was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study procedure was concluded.
Control Group Ten minutes before the platelet apheresis procedure, participants completed the Donor Information Form, BAI, DT, and VAS as pre-tests through face-to-face interviews. Their vital signs were recorded on the Donor Follow-up Chart. During the platelet apheresis procedure, no additional intervention was applied to the donors in the control group, and they continued to receive routine care. Five minutes after the procedure was completed, the BAI, DT, and VAS were administered again as post-tests. Vital signs were recorded, and the study was concluded.
Ethical Considerations Ethical approval for the study was obtained from the institutional ethics committee (research protocol number: 2023.03.01.03). Written permission was also obtained from the institution where the study was conducted. The identities of the researchers and the data obtained from the study were kept confidential.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| müzik resital | Experimental | Other: müzik resital, Device: aferez makinesi, Drug: antikoagülan çözeltiDuring the platelet apheresis donation, instrumental music was played for the participant for 30 minutes. |
| stres topu | Experimental | Other: stres topu, Device: aferez makinesi, Drug: antikoagülan çözeltiThe participant was instructed to squeeze a stress ball for 30 minutes during the platelet apheresis donation. |
| kontrol grubu | No intervention | –Routine treatment and follow-up were continued, and no intervention was applied. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Were literate in Turkish
- Had no physical limitations preventing them from squeezing a stress ball
- Had no psychiatric disorders or visual, auditory, or perceptual impairments
- Met the institution's platelet apheresis donation criteria
- Were donating platelets for the first time
Key exclusion criteria (6 listed)
- Withdrew from platelet apheresis donation
- Wished to withdraw from the study
- Developed a reaction during the donation
- Had insufficient blood flow through the catheter
- Were unable to complete the platelet apheresis donation
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 |
|---|---|---|
| müzik resitalAfter the platelet apheresis procedure began, donors in the music listening group were exposed to instrumental music composed of Classical Turkish Music modes for 30 minutes through the center's speaker system. | Other | müzik resital |
| stres topuWhen the platelet apheresis procedure began, a stress ball was placed in the palm of one hand of the donors in the stress ball group. They were instructed to squeeze the ball at their preferred frequency for a total of 30 minutes during the apheresis procedure. | Other | stres topu |
| aferez makinesiAlso: Spektral OptikThe platelet apheresis procedure was performed on donors using an apheresis machine. | Device | müzik resital, stres topu |
| antikoagülan çözeltiAlso: ACD-AIn accordance with the operating principle of the platelet apheresis device, the anticoagulant solution ACD-A is routinely used for all donors. | Drug | müzik resital, stres topu |
Primary outcome
Pain Intensity Measured by the Visual Analogue Scale (VAS)
Time frame: 30 minutes
The Visual Analogue Scale (VAS) is a validated, self-reported measure used to assess pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity. Pain will be measured immediately before and immediately after the platelet apheresis procedure.
Anxiety Levels Measured by the Beck Anxiety Inventory (BAI)
Time frame: 30 minutes
The Beck Anxiety Inventory (BAI) is a 21-item, self-reported questionnaire used to assess the severity of anxiety symptoms. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate higher levels of anxiety. Anxiety will be measured immediately before and immediately after the platelet apheresis procedure in all groups.
Stress Levels Measured by the Distress Thermometer (DT)
Time frame: 30 minutes
The Distress Thermometer (DT) is a validated, self-reported screening tool used to assess stress and distress levels. It consists of a single-item visual scale ranging from 0 to 10, where 0 indicates no stress/distress and 10 indicates extreme stress/distress. Higher scores represent higher levels of stress. Stress levels will be measured immediately before and immediately after the platelet apheresis procedure in all groups.
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 24 Dec 2025.
- Background: PubMed 36335480Wen X, Shi J, Tan W, Jiang H, Wang D, Su J, Yang G, Zhang B. Effects of aromatherapy and music therapy on patients' anxiety during MRI examinations: a randomized controlled trial. Eur Radiol. 2023 Apr;33(4):2510-2518. doi: 10.1007/s00330-022-09230-3. Epub 2022 Nov 6.
- Background: PubMed 36031855Abdul Hamid MR, Mansor MB, Zainal Abidin MF. Music therapy for reducing anxiety in patients undergoing total knee replacement surgery under subarachnoid anesthesia. J Orthop Surg (Hong Kong). 2022 May-Aug;30(2):10225536221122347. doi: 10.1177/10225536221122347.
- Background: PubMed 30027283Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.
- Background: PubMed 34111207Duncanson E, Le Leu RK, Shanahan L, Macauley L, Bennett PN, Weichula R, McDonald S, Burke ALJ, Collins KL, Chur-Hansen A, Jesudason S. The prevalence and evidence-based management of needle fear in adults with chronic disease: A scoping review. PLoS One. 2021 Jun 10;16(6):e0253048. doi: 10.1371/journal.pone.0253048. eCollection 2021.
- Background: PubMed 9131880Kabacoff RI, Segal DL, Hersen M, Van Hasselt VB. Psychometric properties and diagnostic utility of the Beck Anxiety Inventory and the State-Trait Anxiety Inventory with older adult psychiatric outpatients. J Anxiety Disord. 1997 Jan-Feb;11(1):33-47. doi: 10.1016/s0887-6185(96)00033-3.
- Background: PubMed 30280915Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.
- Background: PubMed 1437591Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.
- Individual participant dataSharing planned: No. I prefer not to
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Seval SA Akpınar, Seval a study director
namık kemal üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing müzik resital, stres topu and aferez makinesi in people with Anxiety and Stress, run by Saglik Bilimleri Universitesi 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 8 inclusion and 6 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 24 Dec 2025. 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?
Pain Intensity Measured by the Visual Analogue Scale (VAS) (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07300618, which also lists 7 linked publications.
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 24 Dec 2025.