Coronary Artery DiseaseNCT05867394
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
A study testing Stress ball in people with Coronary Artery Disease, run by Aysel Sesci at 1 site in Turkey (Türkiye).
Trial summary
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Stress ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 1 Jun 2023
- 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
- 18 years and over
- For those who will undergo coronary angiography for the first time
- Able to read and write
- Not diagnosed with anxiety disorder and not using medication for it
- No physical disability to use the stress ball
- Cognitive health levels consist of individuals who are suitable for answering data collection forms.
Who cannot join
- Unconscious and not fully oriented
- Sight and hearing problems
- Alzheimer's disease and other types of dementia
- Having a severe psychiatric problem that cannot answer the questions
- Those who came with MI (myocardial infarction) and performed CAG
- Individuals who are closed to communicating are not included in this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aysel SESCİ
Aksaray, University, 68000
Aysel SESCİ, 03822882903
About this study
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.
Read the detailed description
Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.
- Conditions
- Coronary Artery Disease
- Being tested
- Stress ball
- Keywords
- coronary angiography, stress, anxiety, vital signs
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballOther
Stress ball squeeze
| Study group | Role | What they receive |
|---|---|---|
| Stress ball | Experimental | Data were collected by the investigator 25-30 minutes before coronary angiography and the first measurement of vital signs was made. After the stress ball application, State Anxiety Inventory data were collected for the second time and the second measurement of vital signs was made. Vital signs were measured and noted for the third time after coronary angiography. Receives: Other: Stress ball |
| Control | No intervention | 25-30 minutes before the coronary angiography procedure, data were collected from the patients by the investigator and the first measurements of their vital signs were recorded. Vital signs were measured a second time just before coronary angiography without any intervention. Vital signs were measured and recorded for the third time after coronary angiography ischemia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Score
Scale measuring patients' anxiety. The scores obtained from the scale vary between 20 and 80. A large score indicates high anxiety, and a small score indicates low anxiety.
Measured: Change in state anxiety score within one day
Secondary outcomes (6)
Distress Thermometer
It is a scale that measures the patient's stress level. The scale is scored between 0 and 10 points. A score of 0 indicates no stress, and a score of 10 indicates extreme stress.
Measured: Only on day 1, 2 times a day (same day).
Systolic Blood Pressure Value (mmHg)
The effect of the intervention on systolic blood pressure is examined.
Measured: Only on day 1, 2 times a day (same day).
Diastolic Blood Pressure Value (mmHg)
The effect of the intervention on diastolic blood pressure is examined.
Measured: It will be measured 3 times a day (same day) on day 1 only.
Heart Rate/Minute Value
The effect of the intervention on the heart rate is examined.
Measured: It will be measured 3 times a day (same day) on day 1 only.
Respiratory Rate/Minute Value
The effect of the intervention on the respiratory rate is examined.
Measured: It will be measured 3 times a day (same day) on day 1 only.
Peripheral Oxygen Saturation (SpO2) Value
The effect of the intervention on peripheral oxygen saturation is examined.
Measured: It will be measured 3 times a day (same day) on day 1 only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start15 Nov 2022
- Primary completion30 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Model description
- Parallel Assignment Prospective Randomized Controlled Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysel Sesci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysel Sesci, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867394
- Sponsor's protocol ID
- Aksaray Üniversitesi
- Status last verified
- May 2023
- First submitted
- 28 Feb 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs
- ClinicalTrials.gov ID
- NCT05867394
- Acronym / sponsor ID
- Aksaray Üniversitesi
- Conditions
- Coronary Artery Disease
- Keywords
- coronary angiography, stress, anxiety, vital signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Aysel SesciUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 May 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.
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.
Detailed description
Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment Prospective Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Stress ball | Experimental | Other: Stress ballData were collected by the investigator 25-30 minutes before coronary angiography and the first measurement of vital signs was made. After the stress ball application, State Anxiety Inventory data were collected for the second time and the second measurement of vital signs was made. Vital signs were measured and noted for the third time after coronary angiography. |
| Control | No intervention | –25-30 minutes before the coronary angiography procedure, data were collected from the patients by the investigator and the first measurements of their vital signs were recorded. Vital signs were measured a second time just before coronary angiography without any intervention. Vital signs were measured and recorded for the third time after coronary angiography ischemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and over
- For those who will undergo coronary angiography for the first time
- Able to read and write
- Not diagnosed with anxiety disorder and not using medication for it
- No physical disability to use the stress ball
Key exclusion criteria (6 listed)
- Unconscious and not fully oriented
- Sight and hearing problems
- Alzheimer's disease and other types of dementia
- Having a severe psychiatric problem that cannot answer the questions
- Those who came with MI (myocardial infarction) and performed CAG
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 ballStress ball squeeze | Other | Stress ball |
Primary outcome
State Anxiety Score
Time frame: Change in state anxiety score within one day
Scale measuring patients' anxiety. The scores obtained from the scale vary between 20 and 80. A large score indicates high anxiety, and a small score indicates low anxiety.
6 secondary outcomes
Distress Thermometer
Time frame: Only on day 1, 2 times a day (same day).
Systolic Blood Pressure Value (mmHg)
Time frame: Only on day 1, 2 times a day (same day).
Diastolic Blood Pressure Value (mmHg)
Time frame: It will be measured 3 times a day (same day) on day 1 only.
Heart Rate/Minute Value
Time frame: It will be measured 3 times a day (same day) on day 1 only.
Respiratory Rate/Minute Value
Time frame: It will be measured 3 times a day (same day) on day 1 only.
Peripheral Oxygen Saturation (SpO2) Value
Time frame: It will be measured 3 times a day (same day) on day 1 only.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No. Study protocol
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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.
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 Coronary Artery Disease, run by Aysel Sesci 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 6 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: status not confirmed, as of the sponsor's last update on 22 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysel SESCİ (2903 ext. 0382288, aysel.sesci70@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Score (time frame: Change in state anxiety score within one day). 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 22 May 2023.