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NCT Number: NCT06524999

Effect of Progressive Muscle Relaxation on Anxiety and Comfort

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.

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Key information

Conditions

Muscle Relaxation Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yildirim Beyazıt University

Ankara, Çubuk, 06760, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Muscle Relaxation

Behavioral

This intervention consists of two parts. The first part gives short information about the content and how exercises should be done. It consists of information about deep relaxation. In the second part, there are relaxation exercises accompanied. Both the briefing and the intervention lasted 30 minutes for each patient.

Primary outcomes

  1. State Anxiety Scale

    Time frame: 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 outcomes

  1. The General Comfort Scale Short Form

    Time frame: 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.

  2. The Vital Signs Follow-up (for blood pressure)

    Time frame: 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.

  3. The Vital Signs Follow-up (for pulse)

    Time frame: 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.

  4. The Vital Signs Follow-up (for respiration)

    Time frame: 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.

  5. The Vital Signs Follow-up (saturation)

    Time frame: 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.

  6. The Vital Signs Follow-up (for body temperature)

    Time frame: 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.

  7. The Visual Analog Scale

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

The Effect of Progressive Muscle Relaxation Exercises on Vital Signs, Anxiety And Comfort Level of Patients Undergoing Coronary Angiography

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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