Effect of Progressive Muscle Relaxation on Anxiety and Comfort

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Muscle Relaxation
• Intervention / Treatment: Behavioral: Progressive muscle relaxation

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çubuk
    • Ankara, Çubuk, Turkey, 06760
      • Ankara Yildirim Beyazıt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; In this group, participant were assessed without any other intervention.
Experimental: Progressive muscle relaxation; The researcher provided the intervention group participants face-to-face training on progressive relaxation exercises (PREs) at the first hospitalization. She had developed "A Guide to Progressive Relaxation Exercises" based on a literature review. The guide consisted of 22 steps. After the briefing, the researcher asked each intervention group participant to perform the PREs with voice instructions. The study continued with participants who performed the PRE steps correctly. While the participant was performing PREs, the researcher guided her verbally in line with the guide. After the nurse teaches the PRE technique once, the individual can apply it. Progressive relaxation exercises are performed for about 15-30 minutes.	Behavioral: Progressive muscle relaxation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety Scale	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.	First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The General Comfort Scale Short Form	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.	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 (for blood pressure)	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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 (for pulse)	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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 (for respiration)	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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 (saturation)	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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 Visual Analog Scale	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).	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 (for body temperature)	The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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.

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Investigators: Principal Investigator: Tuğçe Türten Kaymaz, PhD, Ankara Yildirim Beyazıt University; Principal Investigator: Beyza Güney, MSc, Duzce University Faculty of Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; patient comfort; coronary angiography; vital signs; progressive relaxation exercise
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AnkaraYBU-SBF-TTK-02

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
• product manufactured in and exported from the U.S.: No