- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06572670
The Effect of Progressive Relaxation Exercise Performed Before Coronary Angiography
August 23, 2024 updated by: Sevda Korkut, TC Erciyes University
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
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.
Patients in the intervention group will undergo progressive relaxation before undergoing angiography.
Standard practices of the clinic will be applied to the control group.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
No application will be made to the control group before the procedure.
|
|
|
Experimental: Progressive relaxation exercise before coronary angiography
Patients in the intervention group will undergo progressive relaxation before undergoing angiography.
|
Patients in the intervention group will undergo progressive relaxation before undergoing angiography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes after angiography
|
|
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.
|
30 minutes after angiography
|
|
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.
|
30 minutes after angiography
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure to be assessed with monitor
Time Frame: 30 minutes after angiography
|
The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg.
|
30 minutes after angiography
|
|
Pulse to be assessed with monitor
Time Frame: 30 minutes after angiography
|
Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min.
|
30 minutes after angiography
|
|
Respiratory rate
Time Frame: 30 minutes after angiography
|
Respiratory rate will be measured by counting the number of inspirations and expiration from the patient's chest movements.
|
30 minutes after angiography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
September 15, 2024
Primary Completion (Estimated)
February 15, 2025
Study Completion (Estimated)
February 15, 2025
Study Registration Dates
First Submitted
August 23, 2024
First Submitted That Met QC Criteria
August 23, 2024
First Posted (Actual)
August 27, 2024
Study Record Updates
Last Update Posted (Actual)
August 27, 2024
Last Update Submitted That Met QC Criteria
August 23, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2024/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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