Coronary AngiographyNCT06572670

The Effect of Progressive Relaxation Exercise Performed Before Coronary Angiography

A study testing Progressive relaxation exercise before coronary angiography in people with Coronary Angiography and Progressive Relaxation Exercise, run by TC Erciyes University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Angiography, Progressive Relaxation Exercise, Nursing
What is being tested?: Progressive relaxation exercise before coronary angiography
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: 15 Sep 2024to 15 Feb 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who can speak and understand Turkish,
Are over 18 years old,
Have space and time orientation,
Will undergo coronary angiography for the first time,
Do not have any psychiatric illness,
Do not have vision or hearing problems,
Volunteer to participate in the study will be included.

Who cannot join

Patients who experience any pain or have chronic pain before coronary angiography,
Patients who use antihistamines and psychiatric medications,
Patients who do not volunteer to participate in the study,
Patients who have undergone orthopedic surgery or have any medically diagnosed health problems (orthopedic, neurological, psychological) that prevent relaxation exercises,
Patients who have taken sedatives or painkillers up to 5 hours before coronary angiography will not be included in the study.

About this study

Official title: The Effect of Progressive Relaxation Exercise Performed Before Coronary Angiography on Anxiety, Comfort, Pain and Physiological Parameters

This study was planned to examine the effects of progressive relaxation exercise on anxiety, comfort, pain and physiological parameters in patients undergoing coronary angiography. The data of the study will be collected using the Descriptive Characteristics Questionnaire Form, State and Trait Anxiety Inventory, Perianesthesia Comfort Questionnaire, Visual Analog Scale (VAS), Vital Signs Follow-up Form, Complication Follow-up Form and Progressive Relaxation Exercise Application Guidelines.

Read the detailed description

Conditions: Coronary Angiography, Progressive Relaxation Exercise, Nursing
Being tested: Progressive relaxation exercise before coronary angiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Progressive relaxation exercise before coronary angiographyOther
Patients in the intervention group will undergo progressive relaxation before undergoing angiography.

Study groups in NCT06572670
Study group	Role	What they receive
Progressive relaxation exercise before coronary angiography	Experimental	Patients in the intervention group will undergo progressive relaxation before undergoing angiography. Receives: Other: Progressive relaxation exercise before coronary angiography
Control group	No intervention	No application will be made to the control group before the procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

Anxiety level
This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days.
Measured: 30 minutes after angiography
Comfort level
The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences.
Measured: 30 minutes after angiography
Pain level
Pain will be assessed with the Visual Analog Scale. This scale consists of a 10 cm line with values between 0 and 10. The beginning of the line (number 0) indicates "no pain", while the end of the line (number 10) indicates the most severe pain.
Measured: 30 minutes after angiography

Secondary outcomes (3)

Blood pressure to be assessed with monitor
The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg.
Measured: 30 minutes after angiography
Pulse to be assessed with monitor
Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min.
Measured: 30 minutes after angiography
Respiratory rate
Respiratory rate will be measured by counting the number of inspirations and expiration from the patient's chest movements.
Measured: 30 minutes after angiography

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202415 Feb 2025

First posted27 Aug 2024
Study start15 Sep 2024 (estimated)
Primary completion15 Feb 2025 (estimated)
Study completion15 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary AngiographyStudies of the same condition, open and under way.
More trials run by TC Erciyes 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
Masking: None (open label)
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06572670
Sponsor's protocol ID: 2024/30
Status last verified: Aug 2024
First submitted: 23 Aug 2024
Last updated: 27 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Progressive Relaxation Exercise Performed Before Coronary Angiography on Anxiety, Comfort, Pain and Physiological Parameters
ClinicalTrials.gov ID: NCT06572670
Acronym / sponsor ID: 2024/30
Conditions: Coronary Angiography, Progressive Relaxation Exercise, Nursing
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 15 Sep 2024 (estimated)
Primary completion: 15 Feb 2025 (estimated)
Study completion: 15 Feb 2025 (estimated)
First posted: 27 Aug 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Progressive relaxation exercise before coronary angiography	Experimental	Other: Progressive relaxation exercise before coronary angiographyPatients in the intervention group will undergo progressive relaxation before undergoing angiography.
Control group	No intervention	–No application will be made to the control group before the procedure.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients who can speak and understand Turkish,
Are over 18 years old,
Have space and time orientation,
Will undergo coronary angiography for the first time,
Do not have any psychiatric illness,

Key exclusion criteria (5 listed)

Patients who experience any pain or have chronic pain before coronary angiography,
Patients who use antihistamines and psychiatric medications,
Patients who do not volunteer to participate in the study,
Patients who have undergone orthopedic surgery or have any medically diagnosed health problems (orthopedic, neurological, psychological) that prevent relaxation exercises,
Patients who have taken sedatives or painkillers up to 5 hours before coronary angiography will not be included 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
Progressive relaxation exercise before coronary angiographyPatients in the intervention group will undergo progressive relaxation before undergoing angiography.	Other	Progressive relaxation exercise before coronary angiography

Primary outcome

Anxiety level
Time frame: 30 minutes after angiography
This inventory, which consists of a total of 40 items, is analyzed in two separate sections: The first part is the State Anxiety Inventory, which consists of 20 items, and the individual answers this section with his/her current feelings. The second part is the Trait Anxiety Inventory, which also consists of 20 items, and the individual answers this section with the feelings they have felt in the last 7 days.
Comfort level
Time frame: 30 minutes after angiography
The scale, which is based on the concept of comfort, consists of a total of 24 items, 12 of which question the comfort status of the individual before and after the surgical intervention, 12 of which question positive and 12 of which question negative experiences.
Pain level
Time frame: 30 minutes after angiography
Pain will be assessed with the Visual Analog Scale. This scale consists of a 10 cm line with values between 0 and 10. The beginning of the line (number 0) indicates "no pain", while the end of the line (number 10) indicates the most severe pain.

3 secondary outcomes

Blood pressure to be assessed with monitor
Time frame: 30 minutes after angiography
Pulse to be assessed with monitor
Time frame: 30 minutes after angiography
Respiratory rate
Time frame: 30 minutes after angiography

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Individual participant dataSharing planned: No

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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Progressive relaxation exercise before coronary angiography in people with Coronary Angiography and Progressive Relaxation Exercise, run by TC Erciyes 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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. 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?

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?

Anxiety level (time frame: 30 minutes after angiography). 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 NCT06572670.

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 27 Aug 2024.