Integrative Medicine on Exam Anxiety

Sponsor
Istanbul Saglik Bilimleri University (Other)
Overall Status
Completed
CT.gov ID
NCT03645811
Collaborator
(none)
96
1
3
16.4
5.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music Therapy
  • Behavioral: EFT
N/A

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

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Students who arrived on the day of the exam were assigned to the music therapy (M1 and M2), and EFT (E1 and E2) groups, and the control group (K1 and K2).
Primary Purpose:
Supportive Care
Official Title:
Music Therapy and EFT: Integrative Medicine on Exam Anxiety in Turkish Nursing Students
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
May 31, 2017
Actual Study Completion Date :
May 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Implementation of music therapy

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.

Behavioral: Music Therapy
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.

Experimental: Implementation of EFT

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: Preparation Tapping Series The Nine Gamut Sequence and Eye Movements

Behavioral: EFT
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.

No Intervention: Control

For the control group, 15 minutes of free time was given.

Outcome Measures

Primary Outcome Measures

  1. The Situational-Continuous Anxiety Inventory [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • did not volunteer to participate in the study

  • arrived late or did not turn up

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medipol Universtiy Istanbul Turkey 34668

Sponsors and Collaborators

  • Istanbul Saglik Bilimleri University

Investigators

  • Principal Investigator: Demet İnangil, PhD, Sağlık Bilimleri University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Demet İnangil, PhD, Assistant Professor, Istanbul Saglik Bilimleri University
ClinicalTrials.gov Identifier:
NCT03645811
Other Study ID Numbers:
  • 10840098-604.01.01-E.11892
First Posted:
Aug 24, 2018
Last Update Posted:
Mar 11, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Demet İnangil, PhD, Assistant Professor, Istanbul Saglik Bilimleri University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Music Therapy Emotional Freedom Technique Control
Arm/Group Description In the study, music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 15 minutes under the supervision of the investigators using an MP3 player. Music Therapy: 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. The EFT application protocol was explained to the students with the help of the image in the picture. The method was applied through the investigators tapping on their bodies and the students repeating the steps. EFT: 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. For the control group, 15 minutes of free time was given.
Period Title: Overall Study
STARTED 32 32 32
COMPLETED 30 30 30
NOT COMPLETED 2 2 2

Baseline Characteristics

Arm/Group Title Implementation of Music Therapy Implementation of EFT Control Total
Arm/Group Description 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. Music Therapy: 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. 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: Preparation Tapping Series The Nine Gamut Sequence and Eye Movements EFT: 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. For the control group, 15 minutes of free time was given. Total of all reporting groups
Overall Participants 30 30 30 90
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
30
100%
30
100%
30
100%
90
100%
>=65 years
0
0%
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
18.96
(0.88)
19.1
(0.88)
19.53
(1.07)
19.27
(1.06)
Sex: Female, Male (Count of Participants)
Female
27
90%
23
76.7%
24
80%
74
82.2%
Male
3
10%
7
23.3%
6
20%
16
17.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
30
100%
30
100%
30
100%
90
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%

Outcome Measures

1. Primary Outcome
Title The Situational-Continuous Anxiety Inventory
Description 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.
Time Frame Immediately after intervention completion, an average of 1 hours

Outcome Measure Data

Analysis Population Description
This study was conducted with 90 volunteering students studying at the Faculty of Health Sciences, Department of Nursing, at a foundation university in Medipol University.
Arm/Group Title Music Therapy Emotional Freedom Technique Control
Arm/Group Description In the study, music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 15 minutes under the supervision of the investigators using an MP3 player. Music Therapy: 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. The EFT application protocol was explained to the students with the help of the image in the picture. The method was applied through the investigators tapping on their bodies and the students repeating the steps. EFT: 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. For the control group, 15 minutes of free time was given.
Measure Participants 30 30 30
Median (Inter-Quartile Range) [score on a scale]
44
43
56

Adverse Events

Time Frame 1 day
Adverse Event Reporting Description There was no adverse event during and after interventions.
Arm/Group Title Music Therapy Emotional Freedom Technique (EFT) Control
Arm/Group Description 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 students listened to this music for about 15 minutes. There was no adverse event during and after the intervention. EFT was applied as follows: first, the researcher tapped on different parts of students' bodies and the students repeated the steps for three sessions. Each of the treatment sessions took approximately three minutes, nine minutes in total. There was no adverse event during and after the intervention. For the control group, 15 minutes of free time was given. There was no adverse event during and after the intervention.
All Cause Mortality
Music Therapy Emotional Freedom Technique (EFT) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%) 0/30 (0%)
Serious Adverse Events
Music Therapy Emotional Freedom Technique (EFT) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%) 0/30 (0%)
Other (Not Including Serious) Adverse Events
Music Therapy Emotional Freedom Technique (EFT) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%) 0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Demet İnangil
Organization University of Health Science
Phone +905303021160
Email demet.inangil@sbu.edu.tr
Responsible Party:
Demet İnangil, PhD, Assistant Professor, Istanbul Saglik Bilimleri University
ClinicalTrials.gov Identifier:
NCT03645811
Other Study ID Numbers:
  • 10840098-604.01.01-E.11892
First Posted:
Aug 24, 2018
Last Update Posted:
Mar 11, 2020
Last Verified:
Feb 1, 2020