Muscle RelaxationNCT06524999
Effect of Progressive Muscle Relaxation on Anxiety and Comfort
A study testing Progressive muscle relaxation in people with Muscle Relaxation and Coronary Artery Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Muscle Relaxation, Coronary Artery Disease
- What is being tested?
- Progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Admission to the intensive care unit after the CAG procedure
- starting analgesic or perlinganit infusion
- wanting to quit the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazıt University
Ankara, Çubuk, 06760
About this study
Official title: 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:
Read more
- Does progressive relaxation exercises affect CAG patients' vital signs.
- Does progressive relaxation exercises affect CAG patients' anxiety levels.
- 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.
- Conditions
- Muscle Relaxation, Coronary Artery Disease
- Being tested
- Progressive muscle relaxation
- Keywords
- Anxiety, coronary angiography, patient comfort, progressive relaxation exercise, vital signs
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation | Experimental | 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. Receives: Behavioral: Progressive muscle relaxation |
| Control | No intervention | In this group, participant were assessed without any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: First assessment; before intervention. Second assessment; immediately after the muscle exercise, immediately before the angiography. Third assessment; approximately 30 minute after the angiography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Türten Kaymaz, Ankara Yildirim Beyazıt University
- Investigators
- Tuğçe Türten Kaymaz, PhD, Principal investigator, Ankara Yildirim Beyazıt UniversityBeyza Güney, MSc, Principal investigator, Duzce University Faculty of Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524999
- Sponsor's protocol ID
- AnkaraYBU-SBF-TTK-02
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Vital Signs, Anxiety And Comfort Level of Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT06524999
- Acronym / sponsor ID
- AnkaraYBU-SBF-TTK-02
- Conditions
- Muscle Relaxation, Coronary Artery Disease
- Keywords
- Anxiety, coronary angiography, patient comfort, progressive relaxation exercise, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does progressive relaxation exercises affect CAG patients' vital signs.
- Does progressive relaxation exercises affect CAG patients' anxiety levels.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation | Experimental | Behavioral: Progressive muscle relaxationThe 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. |
| Control | No intervention | –In this group, participant were assessed without any other intervention. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Admission to the intensive care unit after the CAG procedure
- starting analgesic or perlinganit infusion
- wanting to quit the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive muscle relaxationThis 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. | Behavioural | Progressive muscle relaxation |
Primary outcome
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.
7 secondary outcomes
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 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 (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 (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 (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 (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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Muscle Relaxation
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğçe Türten Kaymaz, PhD principal investigator
Ankara Yildirim Beyazıt University
Beyza Güney, MSc principal investigator
Duzce University Faculty of Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation in people with Muscle Relaxation and Coronary Artery Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.