Effect of Progressive Muscle Relaxation on Anxiety and Comfort

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Muscle Relaxation

• Registration Number: NCT06524999
• Lead Sponsor: Ankara Yildirim Beyazıt University

Brief Summary

This study aimed to examine the effect of relaxation exercise applied to patients who will undergo elective coronary angiography (CAG) for the first time, on their vital signs, anxiety and comfort levels.

The main questions it aims to answer are:

1. Does progressive relaxation exercises affect CAG patients' vital signs.

2. Does progressive relaxation exercises affect CAG patients' anxiety levels.

3. Does progressive relaxation exercises affect CAG patients' comfort levels. Researchers will compare the intervention group with the control group to see if relaxation exercise is effective.

Before coronary angiography, patients will undergo a relaxation exercise once. Vital signs, comfort and anxiety level will be evaluated before and after angiography.

Detailed Description

Coronary angiography (CAG) is considered the "gold standard" in determining coronary anatomy. And it is used very frequently in the diagnosis and treatment of coronary artery disease. CAG, which is an invasive procedure, causes anxiety in patients undergoing the procedure. Anxiety leads to negative consequences in vital signs such as increased blood pressure, pulse and respiration rate, and pain intensity. Pain, anxiety and many factors that develop due to invasive procedures such as angiography also reduce the comfort level of patients. Reducing anxiety and pain, preventing negativities in vital signs, and increasing comfort contribute to the success of the procedure, the patient's level of well-being, and satisfaction with health care services. This study aimed to determine the effect of progressive relaxation exercise on patients' vital signs, anxiety and comfort levels in patients undergoing angiography.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Status Verified: 2024-08
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• undergo CAG for the first time
• has a chest score of 5 or less on the pain scale
• has no history of mental disorder according to medical records
• is able to communicate

Exclusion Criteria

• Admission to the intensive care unit after the CAG procedure
• starting analgesic or perlinganit infusion
• wanting to quit the research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
State Anxiety Scale	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The State Anxiety Scale (SAS) shows how an individual feels under certain circumstances at certain times. It consists of 20 items rated on a four-point Likert-type scale ("1: none" to "4: all"). The total score ranges from 20 to 80, with higher scores indicating more anxiety.

Secondary Outcome Measures

Name	Time	Method
The Vital Signs Follow-up (saturation)	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of saturation.
The Vital Signs Follow-up (for blood pressure)	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of blood pressure.
The Vital Signs Follow-up (for pulse)	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of pulse.
The Visual Analog Scale	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Visual Analog Scale (VAS) is a 10 cm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The VAS is scored on a scale of 0 to 10 (0 = no pain, 1-3 = mild pain, 4-7 moderate pain, 8-10 = severe pain).
The General Comfort Scale Short Form	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The General Comfort Scale Short Form assesses how comfortable an individual feels at the moment. The form consists of 28 items rated on a six-point Likert-type scale ("1=strongly disagree" to "6=strongly agree"). The total score ranges from 28 to 168, with higher scores indicating higher levels of comfort.
The Vital Signs Follow-up (for respiration)	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of respiration.
The Vital Signs Follow-up (for body temperature)	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of body temperature.

Trial Locations

Locations (1)

Ankara Yildirim Beyazıt University; 🇹🇷 Ankara, Çubuk, Turkey