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CompletedNCT06524999Updated Jul 24, 2025

Effect of Progressive Muscle Relaxation on Anxiety and Comfort

An interventional study of Progressive muscle relaxation in Muscle Relaxation and Coronary Artery Disease, sponsored by Ankara Yildirim Beyazıt University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-24.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jun 2022, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Relaxation
  • Coronary Artery Disease

Keywords

  • Anxiety
  • coronary angiography
  • patient comfort
  • progressive relaxation exercise
  • vital signs
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 70 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 228 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Admission to the intensive care unit after the CAG procedure
  • starting analgesic or perlinganit infusion
  • wanting to quit the research
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    In this group, participant were assessed without any other intervention.

Interventions

  • BehavioralProgressive 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

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

    The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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.

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

    The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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.

  5. The Vital Signs Follow-up (saturation)

    The Vital Signs Follow-up Chart was developed by the researchers to record the parameters of 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.

  6. 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.

    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.

  7. 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).

    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.

07

Study locations

1 site
  • Ankara Yildirim Beyazıt University
    Ankara, Çubuk 06760, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06524999
Lead sponsor
Ankara Yildirim Beyazıt University
Responsible party
Tuğçe Türten Kaymaz (Assist. Prof., Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Jul 29, 2024
Start date
Jun 1, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jul 24, 2025

Study contacts

Tuğçe Türten Kaymaz, PhD
principal investigator · Ankara Yildirim Beyazıt University
Beyza Güney, MSc
principal investigator · Duzce University Faculty of Medicine Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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