Clinical trial NCT06524999: Effect of Progressive Muscle Relaxation on Anxiety and Comfort
Official title: The Effect of Progressive Muscle Relaxation Exercises on Vital Signs, Anxiety And Comfort Level of Patients Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Relaxation
Coronary Artery Disease
Keywords: Anxiety
coronary angiography
patient comfort
progressive relaxation exercise
vital signs
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized-controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: State Anxiety Scale
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
Secondary outcomes:
measure: The General Comfort Scale Short Form
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Vital Signs Follow-up (for blood pressure)
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Vital Signs Follow-up (for pulse)
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Vital Signs Follow-up (for respiration)
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Vital Signs Follow-up (saturation)
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Vital Signs Follow-up (for body temperature)
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
measure: The Visual Analog Scale
timeFrame: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazıt University
state: Çubuk
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Tuğçe Türten Kaymaz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duzce University Faculty of Medicine Hospital
name: Beyza Güney, MSc
role: PRINCIPAL_INVESTIGATOR
References: