The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs

May 19, 2023 updated by: Aysel Sesci
It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • University
      • Aksaray, University, Turkey, 68000
        • Recruiting
        • Aysel SESCİ
        • Contact:
          • Aysel SESCİ
          • Phone Number: 03822882903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress ball
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.
Other: Stress ball
Stress ball squeeze
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change in state anxiety score within one day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distress Thermometer
Time Frame: Only on day 1, 2 times a day (same day).
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.
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).
The effect of the intervention on systolic blood pressure is examined.
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.
The effect of the intervention on diastolic blood pressure is examined.
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.
The effect of the intervention on the heart rate is examined.
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.
The effect of the intervention on the respiratory rate is examined.
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.
The effect of the intervention on peripheral oxygen saturation is examined.
It will be measured 3 times a day (same day) on day 1 only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aysel Sesci

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Aksaray Üniversitesi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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