Anxiety StateNCT06806878
Progressive Muscle Relaxation Exercises and Anxiety
A study testing Progressive muscle relaxation in people with Anxiety State and Progressive Muscle Relaxation, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).
Trial summary
Nursing practice education consists of two parts: laboratory applications aiming at skill acquisition of students and the application part experienced on real patients. Student nurses gain their first skills in laboratory applications accompanied by an instructor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Progressive Muscle Relaxation, Nursing Students
- What is being tested?
- Progressive muscle relaxation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 4 Mar 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students who volunteered to participate in the study
- took the 'Fundamentals of Nursing' lesson for the first time
Who cannot join
- Students who are foreign nationals,
- who have taken the course more than once due to absenteeism or failure,
- who have come with horizontal or vertical transfer,
- who are graduates of Health Vocational High School,
- who have previous injection experience
- who have been diagnosed with anxiety,
- students who do not want to participate in the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Necmettin Erbakan University
Konya, Meram, 42090
Necmettin Erbakan University
Meram
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercıses Applied to Nursing Students on Success and Anxiety Related to Intramuscular Injection Practice
Nursing practice education consists of two parts: laboratory applications aiming at skill acquisition of students and the application part experienced on real patients. Student nurses gain their first skills in laboratory applications accompanied by an instructor. This experience may increase the anxiety levels of nursing students due to reasons such as practising for the first time, hesitating to practice under the supervision of an instructor, and fear of making mistakes. If students learn intramuscular injection, which is one of the skill applications that is a part of care, which is the most important power of nursing, with increased anxiety levels, it may cause a decrease in clinical competence and a decrease in the quality of health care they will provide in the future. Various methods have been tried for nursing students' anxiety levels to be above the optimum level in laboratory applications and it has been observed that anxiety levels have decreased. One of these methods is progressive muscle relaxation exercises. In this study, it is planned to apply progressive muscle relaxation exercises in order to examine the effect of progressive muscle relaxation exercises on the success and anxiety of nursing students related to intramuscular injection practice.
Materials and Method: In this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skill laboratories, consent will be obtained from the 1st year nursing students. The students will fill in the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study.
Read the detailed description
In this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skill laboratories, consent will be obtained from the 1st year nursing students. The students will fill in the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study.
- Being tested
- Progressive muscle relaxation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxationOther
We will apply progressive muscle relaxation exercises to reduce nursing students' anxiety about intramuscular injection administration
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Experimental | In this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skills laboratories, consent will be obtained from 1st year nursing students. The students will fill out the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study. Receives: Other: Progressive muscle relaxation |
| no intervention | No intervention | students will not take any intervention before ım injection application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students anxiety
Students anxiety level will be evaluated by using the "visual anxiety scale" consisting of 100 mm horizontal lines without numbers. At one end of the line is "No Anxiety" and at the other end is "Unbearable Anxiety". The student is expected to put a mark on this line at the point that matches the level of their anxiety. The distance from the lowest level to the student's mark is measured with a ruler and the numerical value of the anxiety level is obtained in cm or mm.
Measured: This scale will be filled out by students before starting the IM injection skill practice and within 10 minutes after the IM practice is completed.
Secondary outcomes (1)
Intramuscular Injection Success Test
Intramuscular Injection Success Test is a test consisting 21 multiple choice question. Each correct answer is considered as "1" point, unanswered questions are not scored. Test scores are evaluated out of a total of 21 points.
Measured: this test will be answered before and within 10 minutes after im injection implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start3 Mar 2025
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulden Basit, Necmettin Erbakan University
- Investigators
- Gülden Basit, Dr, Study chair, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806878
- Sponsor's protocol ID
- 23841101020
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2025
- Last updated
- 15 Apr 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercıses Applied to Nursing Students on Success and Anxiety Related to Intramuscular Injection Practice
- ClinicalTrials.gov ID
- NCT06806878
- Acronym / sponsor ID
- 23841101020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 4 Feb 2025 (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.
Nursing practice education consists of two parts: laboratory applications aiming at skill acquisition of students and the application part experienced on real patients. Student nurses gain their first skills in laboratory applications accompanied by an instructor. This experience may increase the anxiety levels of nursing students due to reasons such as practising for the first time, hesitating to practice under the supervision of an instructor, and fear of making mistakes. If students learn intramuscular injection, which is one of the skill applications that is a part of care, which is the most important power of nursing, with increased anxiety levels, it may cause a decrease in clinical competence and a decrease in the quality of health care they will provide in the future. Various methods have been tried for nursing students' anxiety levels to be above the optimum level in laboratory applications and it has been observed that anxiety levels have decreased. One of these methods is progressive muscle relaxation exercises. In this study, it is planned to apply progressive muscle relaxation exercises in order to examine the effect of progressive muscle relaxation exercises on the success and anxiety of nursing students related to intramuscular injection practice.
Materials and Method: In this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skill laboratories, consent will be obtained from the 1st year nursing students. The students will fill in the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study.
Detailed description
In this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skill laboratories, consent will be obtained from the 1st year nursing students. The students will fill in the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Experimental | Other: Progressive muscle relaxationIn this pre-test-post-test randomised controlled study planned to be conducted in Necmettin Erbakan University Faculty of Nursing skills laboratories, consent will be obtained from 1st year nursing students. The students will fill out the descriptive characteristics form, Visual Anxiety Scale and IM injection success test prepared by reviewing the literature before and after intramuscular injection. After the completion of the forms, 'progressive muscle relaxation exercises' will be applied to the students by the researcher for about 30 minutes. Students who volunteered to participate in the study and who took the 'Fundamentals of Nursing' course for the first time will be included in the study. |
| no intervention | No intervention | –students will not take any intervention before ım injection application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Students who volunteered to participate in the study
- took the 'Fundamentals of Nursing' lesson for the first time
Key exclusion criteria (7 listed)
- Students who are foreign nationals,
- who have taken the course more than once due to absenteeism or failure,
- who have come with horizontal or vertical transfer,
- who are graduates of Health Vocational High School,
- who have previous injection experience
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 relaxationWe will apply progressive muscle relaxation exercises to reduce nursing students' anxiety about intramuscular injection administration | Other | Progressive Muscle Relaxation |
Primary outcome
Students anxiety
Time frame: This scale will be filled out by students before starting the IM injection skill practice and within 10 minutes after the IM practice is completed.
Students anxiety level will be evaluated by using the "visual anxiety scale" consisting of 100 mm horizontal lines without numbers. At one end of the line is "No Anxiety" and at the other end is "Unbearable Anxiety". The student is expected to put a mark on this line at the point that matches the level of their anxiety. The distance from the lowest level to the student's mark is measured with a ruler and the numerical value of the anxiety level is obtained in cm or mm.
1 secondary outcome
Intramuscular Injection Success Test
Time frame: this test will be answered before and within 10 minutes after im injection implementation
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 15 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Gülden Basit, Dr study chair
Necmettin Erbakan University
2 sites 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 Anxiety State and Progressive Muscle Relaxation, run by Necmettin Erbakan University at 2 sites 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 2 inclusion and 7 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Students anxiety (time frame: This scale will be filled out by students before starting the IM injection skill practice and within 10 minutes after the IM practice is completed.). 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 15 Apr 2025.