PainstressballNCT06267196
The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
A study testing The use of a stress ball in people with Pain and Anxiety, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial summary
The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- The use of a stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Nov 2023to 15 Mar 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above.
- Patients with cesarean category 3 and 4.
Who cannot join
- Patients under the age of 18
- Patients undergoing emergency cesarean section
- Patients with bleeding disorders
- Individuals with psychological disorders
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Özge Sayın Ayan
Istanbul, Eyup, 34065
özge sayın, +905332965628, ozgesayinayan@gmail.com
volkan özen, +905309276094, vozen81@gmail.com
- Recruiting
Prof.Dr.Cemil Tascioglu City Hospital
Istanbul, Şişli, 34360
özge sayın ayan, +905332965628, ozgesayinayan@gmail.com
volkan özen, +905309276094, vozen81@gmail.com
About this study
The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels
Read the detailed description
Our planned study, which is intended to be conducted as a prospective randomized controlled trial, will include patients aged 18 and above who fall into category 3 and 4 according to the classification used in the study by Lucas et al., and who are undergoing cesarean section.Patient data including age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiologists) score, gravidity, parity, history of abortion, gestational age, medical history, and surgical history will be recorded.The anxiety status of patients will be recorded using the State Anxiety Inventory (STAI-I) score both before and after the procedure.Patients will be divided into two groups using a randomization method. One group will be provided with a stress ball to squeeze during the administration of spinal anesthesia, while the second group will undergo spinal anesthesia without receiving a stress ball.All patients will receive intrathecal injection of 0.05% bupivacaine using a 25-gauge spinal needle. The Visual Analog Scale (VAS) will be assessed and recorded during the procedure to evaluate the patients' pain status.Additionally, the patient's blood pressure, pulse, and saturation levels will be recorded before starting the procedure and 2 minutes after the procedure initiation. Patient satisfaction will be evaluated after the procedure.
- Being tested
- The use of a stress ball
- Keywords
- Stress, Spinal anesthesia
- 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.
The use of a stress ballOther
The effect of the stress ball used during spinal anesthesia on pain and anxiety
| Study group | Role | What they receive |
|---|---|---|
| Stress ball group | Active comparator | The patient group in which a stress ball is used during spinal anesthesia. Receives: Other: The use of a stress ball |
| The control group | No intervention | The group that receives only standard spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress ball and anxiety
The impact of stress ball use during spinal anesthesia on anxiety.The effect will be assessed with the STAI (State-Trait Anxiety Inventory)scale both before and after the procedure. On this scale, the minimum and maximum values range between 20 and 80, and higher values indicate greater stress.
Measured: Before and after the procedure, at 5 minutes.
stress ball and pain
Evaluating the impact of stress ball usage during spinal anesthesia on pain through VAS (Visual Analog Scale) scoresThe VAS score ranges from 0 to 10, with higher values indicating more pain.
Measured: during the procedure
Secondary outcomes (3)
Stress ball and blood pressure
The effect of the stress ball used during spinal anesthesia on the patient's blood pressure.It will be measured before and after the procedure and recorded in mmHg.
Measured: Before and after the procedure, at 3 minutes.
Stress ball and pulse
The impact of the use of the stress ball during spinal anesthesia on the pulse will be assessed.Pulse will be recorded as beats per minute.
Measured: Before and after the procedure, at 3 minutes.
Stress ball and saturation
The impact of using a stress ball during spinal anesthesia on saturation will be evaluated. It will be recorded in percentage.
Measured: Before and after the procedure, at 3 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Nov 2023
- Primary completion2 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Sayın Ayan, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267196
- Sponsor's protocol ID
- CemilTascıogluERHO-AYAN
- Acronym
- stressball
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the individual participant data (IPD) from this study in two formats: an Excel spreadsheet containing detailed data sets and a PDF document summarizing the key findings. The data sharing is scheduled to occur three months after the completion of the study. Data Types and Scope: The Excel spreadsheet will encompass comprehensive participant data, covering all relevant variables collected during the study. The PDF document will provide a concise summary of the study results, highlighting key outcomes and trends.
Publications
Yanes 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 30027283Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.
PubMed 26885298Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
PubMed 25641687
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety
- ClinicalTrials.gov ID
- NCT06267196
- Acronym / sponsor ID
- stressball / CemilTascıogluERHO-AYAN
- Keywords
- Stress, Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 2 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 20 Feb 2024 (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 is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels
Detailed description
Our planned study, which is intended to be conducted as a prospective randomized controlled trial, will include patients aged 18 and above who fall into category 3 and 4 according to the classification used in the study by Lucas et al., and who are undergoing cesarean section.Patient data including age, weight, height, body mass index (BMI), ASA (American Society of Anesthesiologists) score, gravidity, parity, history of abortion, gestational age, medical history, and surgical history will be recorded.The anxiety status of patients will be recorded using the State Anxiety Inventory (STAI-I) score both before and after the procedure.Patients will be divided into two groups using a randomization method. One group will be provided with a stress ball to squeeze during the administration of spinal anesthesia, while the second group will undergo spinal anesthesia without receiving a stress ball.All patients will receive intrathecal injection of 0.05% bupivacaine using a 25-gauge spinal needle. The Visual Analog Scale (VAS) will be assessed and recorded during the procedure to evaluate the patients' pain status.Additionally, the patient's blood pressure, pulse, and saturation levels will be recorded before starting the procedure and 2 minutes after the procedure initiation. Patient satisfaction will be evaluated after the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress ball group | Active comparator | Other: The use of a stress ballThe patient group in which a stress ball is used during spinal anesthesia. |
| The control group | No intervention | –The group that receives only standard spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 and above.
- Patients with cesarean category 3 and 4.
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients undergoing emergency cesarean section
- Patients with bleeding disorders
- Individuals with psychological disorders
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 |
|---|---|---|
| The use of a stress ballThe effect of the stress ball used during spinal anesthesia on pain and anxiety | Other | Stress ball group |
Primary outcome
stress ball and anxiety
Time frame: Before and after the procedure, at 5 minutes.
The impact of stress ball use during spinal anesthesia on anxiety.The effect will be assessed with the STAI (State-Trait Anxiety Inventory)scale both before and after the procedure. On this scale, the minimum and maximum values range between 20 and 80, and higher values indicate greater stress.
stress ball and pain
Time frame: during the procedure
Evaluating the impact of stress ball usage during spinal anesthesia on pain through VAS (Visual Analog Scale) scoresThe VAS score ranges from 0 to 10, with higher values indicating more pain.
3 secondary outcomes
Stress ball and blood pressure
Time frame: Before and after the procedure, at 3 minutes.
Stress ball and pulse
Time frame: Before and after the procedure, at 3 minutes.
Stress ball and saturation
Time frame: Before and after the procedure, at 3 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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 26885298Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.
- Results publication: PubMed 25641687Hudson BF, Ogden J, Whiteley MS. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery. Eur J Pain. 2015 Nov;19(10):1447-55. doi: 10.1002/ejp.675. Epub 2015 Jan 30.
- Individual participant dataSharing planned: Yes. We plan to share the individual participant data (IPD) from this study in two formats: an Excel spreadsheet containing detailed data sets and a PDF document summarizing the key findings. The data sharing is scheduled to occur three months after the completion of the study. Data Types and Scope: The Excel spreadsheet will encompass comprehensive participant data, covering all relevant variables collected during the study. The PDF document will provide a concise summary of the study results, highlighting key outcomes and trends.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The use of a stress ball in people with Pain and Anxiety, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özge Sayın Ayan (+905332965628, ozgesayinayan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress ball and anxiety (time frame: Before and after the procedure, at 5 minutes.). The study lists 2 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 NCT06267196, which also lists 3 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 20 Feb 2024.