AnxietyNCT03645811
Integrative Medicine on Exam Anxiety
A study testing Music Therapy and EFT in people with Anxiety and Educational Problems, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Test anxiety, one of the forms of situational anxiety, is a crucial biopsychological factor negatively affecting the wellbeing and academic performance of students throughout their education. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Educational Problems
- What is being tested?
- Music Therapy and EFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 14 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being 18 years old or above,
- taking the theoretical course of Nursing Principles I and II,
- entering the OSCE on May 31 as part of the Nursing Principles course.
Who cannot join
- did not volunteer to participate in the study
- arrived late or did not turn up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy and EFT: Integrative Medicine on Exam Anxiety in Turkish Nursing Students
Introduction: Test anxiety, one of the forms of situational anxiety, is a crucial biopsychological factor negatively affecting the wellbeing and academic performance of students throughout their education. The study aims to determine the effects of music therapy and EFT (Emotional Freedom Technique) on situational anxiety and vital signs in nursing students before they take the OSCE (Objective Structured Clinical Exam).
The study was a randomized controlled experimental study and conducted with 90 volunteering students studying at the Faculty of Health Sciences, Department of Nursing at a university in Istanbul. A computer-based random number generator was used to randomly assign the students into three groups (Music, EFT, and control), each of which consisted of 30 students. Data collection was carried out using a Student Identification Form, the Situational Anxiety Scale, and the Vital Signs Form.
Read the detailed description
Anxiety - an important concept for describing human behaviors - is a condition in which a number of physiological responses are generated, accompanied by feelings of distress, anxiety, and depression in various scenarios where one feels threatened. Test anxiety experienced by nursing students around the world during their training is one of the most significant problems that hinder the acquisition of professional skills. Students in most nursing programs show poor exam performance due to anxiety caused by the OSCE exam. Studies on test anxiety also show a negative relationship between test anxiety and academic performance. When the literature is examined, it can be seen that stress reduction is very important in allowing students to maximize their learning of practical skills in the vocational education process. Techniques such as music therapy, cognitive therapy, emotional freedom technique (EFT), breathing techniques, mind cleansing, aromatherapy, and relaxation of muscles have been used to reduce the anxiety levels of nursing students . Based on prior research, the aim of the study to determine the effects of the music therapy and EFT (Emotional Freedom Technique), on situational anxiety and vital signs, before the OSCE (Objective Structured Clinical Exam) in nursing students.
This study was conducted with 90 volunteer students studying at the Nursing Department of the Health Sciences Faculty at a foundation university in Medipol University. The data was collected prior to the OSCE on May 31, 2017. Students included in the study were required to meet the eligibility criteria of (a) being 18 years old or above, (b) taking the theoretical course of Nursing Principles I and II, and (c) entering the OSCE on May 31 as part of the Nursing Principles course. All students taking the exam were included in the study without reverting to the method of sample size selection (n = 90). A randomly ordered class list was prepared with the student numbers in the classroom list using the random.org program. According to the newly created list, students were notified in writing one day before about what time to arrive before the exam. Students who arrived on the day of the exam were assigned to the music therapy and EFT groups, and the control group. Each group consisted of 30 students. The students were taken to a 90 m2 practice room. Each group was briefed for five minutes before obtaining their consent. The students had their vital signs measured by the investigators. They were asked to fill out the Student Identification Form and the Situational Anxiety Scale. Afterward, the methods (music and EFT) were applied for 15 minutes. The methods were applied by the investigators who are experts in their fields. After the methods were applied, the students had their vital signs remeasured by the investigators and were asked to fill out the Situational Anxiety Scale. For the control group, pre-measurements were taken, 15 minutes of free time was given, and then post-measurements were taken.
- Conditions
- Anxiety, Educational Problems
- Being tested
- Music Therapy, EFT
- Keywords
- anxiety, OSCE, EFT, music
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player.
EFTBehavioural
EFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions.
| Study group | Role | What they receive |
|---|---|---|
| Implementation of music therapy | Experimental | For the music therapy, lecturers specializing in music therapy were consulted and accordingly a "mahur maqam," an instrumental piece of traditional Turkish music played on the saz, was chosen. The mahur maqam has a descending scale, which has a relaxing impact as it moves along a 1-2 octave sound spectrum. It elicits feelings of joy and positivity, and immediately draws the attention of the listener, helping keep the mind clear. The mahur maqam belongs to the rast maqam family. Rast maqams are usually evocative of feelings of peacefulness, surrender, tranquility, trust, and mystical sentiments. Receives: Behavioral: Music Therapy |
| Implementation of EFT | Experimental | The EFT application protocol was explained to the students with the help of the image in the picture for 5 minutes. The method was applied through the investigator tapping on their bodies and the students repeating the steps for three sessions. Each of the treatment sessions was approximately three minutes, resulting in a nine-minute treatment for intervention. Each EFT session was performed by following the steps below.
The content of each EFT session was as follows:
1. Preparation
2. Tapping Series
3. The Nine Gamut Sequence and Eye Movements Receives: Behavioral: EFT |
| Control | No intervention | For the control group, 15 minutes of free time was given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Situational-Continuous Anxiety Inventory
The Situational Anxiety Scale was used for scoring anxiety. The Situational-Continuous Anxiety Inventory includes two separate scales with a total of 40 items. This study employed the Situational Anxiety Scale. The Situational Anxiety Scale consists of a total of 20 items. Its reliability coefficient varies between 0.83-0.96. The participants were expected to respond to the items according to their feelings and thoughts at that moment. In this study, the Cronbach's alpha value of the Situational Anxiety Scale was 0.92.
The items of the Situational Anxiety Scale are scored on a scale of 1-4 depending on the level at which the mentioned emotions or behaviors were experienced. The total score obtained from the scale can vary between 20 and 80. Higher scores indicate higher levels of anxiety.
Measured: Immediately after intervention completion, an average of 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Jan 2017
- Primary completion31 May 2017
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Demet İnangil, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645811
- Sponsor's protocol ID
- 10840098-604.01.01-E.11892
- Status last verified
- Feb 2020
- First submitted
- 9 Aug 2018
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torabizadeh C, Bostani S, Yektatalab S. Comparison between the effects of muscle relaxation and support groups on the anxiety of nursing students: A randomized controlled trial. Complement Ther Clin Pract. 2016 Nov;25:106-113. doi: 10.1016/j.ctcp.2016.09.001. Epub 2016 Sep 7.
PubMed 27863599Ince S, Cevik K. The effect of music listening on the anxiety of nursing students during their first blood draw experience. Nurse Educ Today. 2017 May;52:10-14. doi: 10.1016/j.nedt.2017.02.009. Epub 2017 Feb 14.
PubMed 28214664Patterson SL. The effect of emotional freedom technique on stress and anxiety in nursing students: A pilot study. Nurse Educ Today. 2016 May;40:104-10. doi: 10.1016/j.nedt.2016.02.003. Epub 2016 Feb 7.
PubMed 27125158
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy and EFT: Integrative Medicine on Exam Anxiety in Turkish Nursing Students
- ClinicalTrials.gov ID
- NCT03645811
- Acronym / sponsor ID
- 10840098-604.01.01-E.11892
- Conditions
- Anxiety, Educational Problems
- Keywords
- anxiety, OSCE, EFT, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 11 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Test anxiety, one of the forms of situational anxiety, is a crucial biopsychological factor negatively affecting the wellbeing and academic performance of students throughout their education. The study aims to determine the effects of music therapy and EFT (Emotional Freedom Technique) on situational anxiety and vital signs in nursing students before they take the OSCE (Objective Structured Clinical Exam).
The study was a randomized controlled experimental study and conducted with 90 volunteering students studying at the Faculty of Health Sciences, Department of Nursing at a university in Istanbul. A computer-based random number generator was used to randomly assign the students into three groups (Music, EFT, and control), each of which consisted of 30 students. Data collection was carried out using a Student Identification Form, the Situational Anxiety Scale, and the Vital Signs Form.
Detailed description
Anxiety - an important concept for describing human behaviors - is a condition in which a number of physiological responses are generated, accompanied by feelings of distress, anxiety, and depression in various scenarios where one feels threatened. Test anxiety experienced by nursing students around the world during their training is one of the most significant problems that hinder the acquisition of professional skills. Students in most nursing programs show poor exam performance due to anxiety caused by the OSCE exam. Studies on test anxiety also show a negative relationship between test anxiety and academic performance. When the literature is examined, it can be seen that stress reduction is very important in allowing students to maximize their learning of practical skills in the vocational education process. Techniques such as music therapy, cognitive therapy, emotional freedom technique (EFT), breathing techniques, mind cleansing, aromatherapy, and relaxation of muscles have been used to reduce the anxiety levels of nursing students . Based on prior research, the aim of the study to determine the effects of the music therapy and EFT (Emotional Freedom Technique), on situational anxiety and vital signs, before the OSCE (Objective Structured Clinical Exam) in nursing students.
This study was conducted with 90 volunteer students studying at the Nursing Department of the Health Sciences Faculty at a foundation university in Medipol University. The data was collected prior to the OSCE on May 31, 2017. Students included in the study were required to meet the eligibility criteria of (a) being 18 years old or above, (b) taking the theoretical course of Nursing Principles I and II, and (c) entering the OSCE on May 31 as part of the Nursing Principles course. All students taking the exam were included in the study without reverting to the method of sample size selection (n = 90). A randomly ordered class list was prepared with the student numbers in the classroom list using the random.org program. According to the newly created list, students were notified in writing one day before about what time to arrive before the exam. Students who arrived on the day of the exam were assigned to the music therapy and EFT groups, and the control group. Each group consisted of 30 students. The students were taken to a 90 m2 practice room. Each group was briefed for five minutes before obtaining their consent. The students had their vital signs measured by the investigators. They were asked to fill out the Student Identification Form and the Situational Anxiety Scale. Afterward, the methods (music and EFT) were applied for 15 minutes. The methods were applied by the investigators who are experts in their fields. After the methods were applied, the students had their vital signs remeasured by the investigators and were asked to fill out the Situational Anxiety Scale. For the control group, pre-measurements were taken, 15 minutes of free time was given, and then post-measurements were taken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implementation of music therapy | Experimental | Behavioral: Music TherapyFor the music therapy, lecturers specializing in music therapy were consulted and accordingly a "mahur maqam," an instrumental piece of traditional Turkish music played on the saz, was chosen. The mahur maqam has a descending scale, which has a relaxing impact as it moves along a 1-2 octave sound spectrum. It elicits feelings of joy and positivity, and immediately draws the attention of the listener, helping keep the mind clear. The mahur maqam belongs to the rast maqam family. Rast maqams are usually evocative of feelings of peacefulness, surrender, tranquility, trust, and mystical sentiments. |
| Implementation of EFT | Experimental | Behavioral: EFTThe EFT application protocol was explained to the students with the help of the image in the picture for 5 minutes. The method was applied through the investigator tapping on their bodies and the students repeating the steps for three sessions. Each of the treatment sessions was approximately three minutes, resulting in a nine-minute treatment for intervention. Each EFT session was performed by following the steps below. The content of each EFT session was as follows: 1. Preparation 2. Tapping Series 3. The Nine Gamut Sequence and Eye Movements |
| Control | No intervention | –For the control group, 15 minutes of free time was given. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being 18 years old or above,
- taking the theoretical course of Nursing Principles I and II,
- entering the OSCE on May 31 as part of the Nursing Principles course.
Key exclusion criteria (2 listed)
- did not volunteer to participate in the study
- arrived late or did not turn up
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 |
|---|---|---|
| Music TherapyMusic therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player. | Behavioural | Implementation of music therapy |
| EFTEFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions. | Behavioural | Implementation of EFT |
Primary outcome
The Situational-Continuous Anxiety Inventory
Time frame: Immediately after intervention completion, an average of 1 hours
The Situational Anxiety Scale was used for scoring anxiety. The Situational-Continuous Anxiety Inventory includes two separate scales with a total of 40 items. This study employed the Situational Anxiety Scale. The Situational Anxiety Scale consists of a total of 20 items. Its reliability coefficient varies between 0.83-0.96. The participants were expected to respond to the items according to their feelings and thoughts at that moment. In this study, the Cronbach's alpha value of the Situational Anxiety Scale was 0.92. The items of the Situational Anxiety Scale are scored on a scale of 1-4 depending on the level at which the mentioned emotions or behaviors were experienced. The total score obtained from the scale can vary between 20 and 80. Higher scores indicate higher levels of anxiety.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27863599Torabizadeh C, Bostani S, Yektatalab S. Comparison between the effects of muscle relaxation and support groups on the anxiety of nursing students: A randomized controlled trial. Complement Ther Clin Pract. 2016 Nov;25:106-113. doi: 10.1016/j.ctcp.2016.09.001. Epub 2016 Sep 7.
- Background: PubMed 28214664Ince S, Cevik K. The effect of music listening on the anxiety of nursing students during their first blood draw experience. Nurse Educ Today. 2017 May;52:10-14. doi: 10.1016/j.nedt.2017.02.009. Epub 2017 Feb 14.
- Background: PubMed 27125158Patterson SL. The effect of emotional freedom technique on stress and anxiety in nursing students: A pilot study. Nurse Educ Today. 2016 May;40:104-10. doi: 10.1016/j.nedt.2016.02.003. Epub 2016 Feb 7.
- 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.
Demet İnangil, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and EFT in people with Anxiety and Educational Problems, run by Istanbul Saglik Bilimleri 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 3 inclusion and 2 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 11 Mar 2020. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Situational-Continuous Anxiety Inventory (time frame: Immediately after intervention completion, an average of 1 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645811, which also lists 3 linked publications.
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 11 Mar 2020.