AnxietyNCT04540172
The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice
A study testing Music Therapy and Progressive Muscle Relaxation Exercise in people with Anxiety and Stress, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Music Therapy and Progressive Muscle Relaxation Exercise
- 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 Aug 2019to 1 Dec 2019
- 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
- being 18 years or older,
- being enrolled in the Nursing Fundamentals theoretical course,
- participating fully in the attempts being applied in the study,
- volunteering to participate in the study.
Who cannot join
- be graduating from Health Vocational High School
- not being in the field of application determined on the first clinical application day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy and Progressive Muscle Relaxation Exercise
This study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.
Read the detailed description
This randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice. The students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups. The data of the study were collected with Student Information Form and State-Trait Anxiety Scale. The music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.
- Being tested
- Music Therapy, Progressive Muscle Relaxation Exercise
- 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
"Mahur tune," one of the nonverbal instruments of the Traditional Turkish Music Authorities, was selected for the study with the opinion of a music therapy specialist.
Progressive Muscle Relaxation ExerciseBehavioural
In this study, the steps of applying progressive muscle relaxation exercise were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | music therapy was applied in the practice room. Environmental noise was reduced as much as possible; the room was dimly lit. The students were asked to close their eyes after sitting comfortably in a chair and focus on the music by asking them to imagine a different memory and place that would relax them instead of the thoughts that occupied their minds. The music was played through a portable computer for 15 minutes under the supervision of the researchers using an mp3 player program on the computer. Receives: Behavioral: Music Therapy |
| Progressive Muscle Relaxation Exercise | Experimental | In this study, the steps of applying progressive muscle relaxation exercises were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association. Warning messages were hung on the door of the room, environmental noise was reduced as much as possible, and the room was provided with dim lighting. The students were asked to close their eyes and breathe deeply after sitting comfortably in a chair. After taking two deep breaths, they were told to dangle their arms and relax as much as possible. The hands, shoulders, neck, chest, abdomen, hips, legs, feet, toes, and facial muscles were made to relax while they breathed and relaxed while exhaling. They were asked to store the experience into their memories thoroughly so that they could recall this feeling for comfort during the day. Receives: Behavioral: Progressive Muscle Relaxation Exercise |
| Control | No intervention | No additional method was applied in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The level of Anxiety was evaluated with the State-Trait Anxiety Inventory (STAI). STAI consists of 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (None" (1), "A little" (2), "Very" (3), and "Completely" (4). Higher scores indicate greater anxiety.
Measured: Change from baseline in 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Aug 2019
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- Merdiye Şendir, PhD, Study chair, Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540172
- Sponsor's protocol ID
- 46418926
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dehghan-Nayeri N, Adib-Hajbaghery M. Effects of progressive relaxation on anxiety and quality of life in female students: a non-randomized controlled trial. Complement Ther Med. 2011 Aug;19(4):194-200. doi: 10.1016/j.ctim.2011.06.002. Epub 2011 Jul 12.
PubMed 21827933Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
PubMed 23260618Inangil D, Sendir M, Kabuk A, Turkoglu I. The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice in Nursing Students: A Randomized Controlled Study. Florence Nightingale J Nurs. 2020 Oct 26;28(3):341-349. doi: 10.5152/FNJN.2020.19075. eCollection 2020 Oct.
PubMed 34263213
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy and Progressive Muscle Relaxation Exercise
- ClinicalTrials.gov ID
- NCT04540172
- Acronym / sponsor ID
- 46418926
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 7 Sep 2020 (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 was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.
Detailed description
This randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice. The students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups. The data of the study were collected with Student Information Form and State-Trait Anxiety Scale. The music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music Therapymusic therapy was applied in the practice room. Environmental noise was reduced as much as possible; the room was dimly lit. The students were asked to close their eyes after sitting comfortably in a chair and focus on the music by asking them to imagine a different memory and place that would relax them instead of the thoughts that occupied their minds. The music was played through a portable computer for 15 minutes under the supervision of the researchers using an mp3 player program on the computer. |
| Progressive Muscle Relaxation Exercise | Experimental | Behavioral: Progressive Muscle Relaxation ExerciseIn this study, the steps of applying progressive muscle relaxation exercises were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association. Warning messages were hung on the door of the room, environmental noise was reduced as much as possible, and the room was provided with dim lighting. The students were asked to close their eyes and breathe deeply after sitting comfortably in a chair. After taking two deep breaths, they were told to dangle their arms and relax as much as possible. The hands, shoulders, neck, chest, abdomen, hips, legs, feet, toes, and facial muscles were made to relax while they breathed and relaxed while exhaling. They were asked to store the experience into their memories thoroughly so that they could recall this feeling for comfort during the day. |
| Control | No intervention | –No additional method was applied in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being 18 years or older,
- being enrolled in the Nursing Fundamentals theoretical course,
- participating fully in the attempts being applied in the study,
- volunteering to participate in the study.
Key exclusion criteria (2 listed)
- be graduating from Health Vocational High School
- not being in the field of application determined on the first clinical application day.
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 Therapy"Mahur tune," one of the nonverbal instruments of the Traditional Turkish Music Authorities, was selected for the study with the opinion of a music therapy specialist. | Behavioural | Music Therapy |
| Progressive Muscle Relaxation ExerciseIn this study, the steps of applying progressive muscle relaxation exercise were created with the guidance of the "Relaxation Exercises " materials of the Turkish Psychological Association. | Behavioural | Progressive Muscle Relaxation Exercise |
Primary outcome
Anxiety
Time frame: Change from baseline in 1 week
The level of Anxiety was evaluated with the State-Trait Anxiety Inventory (STAI). STAI consists of 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (None" (1), "A little" (2), "Very" (3), and "Completely" (4). Higher scores indicate greater anxiety.
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 9 Sep 2020.
- Background: PubMed 21827933Dehghan-Nayeri N, Adib-Hajbaghery M. Effects of progressive relaxation on anxiety and quality of life in female students: a non-randomized controlled trial. Complement Ther Med. 2011 Aug;19(4):194-200. doi: 10.1016/j.ctim.2011.06.002. Epub 2011 Jul 12.
- Background: PubMed 23260618Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
- Derived from this study: PubMed 34263213Inangil D, Sendir M, Kabuk A, Turkoglu I. The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice in Nursing Students: A Randomized Controlled Study. Florence Nightingale J Nurs. 2020 Oct 26;28(3):341-349. doi: 10.5152/FNJN.2020.19075. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Merdiye Şendir, PhD study chair
Saglik Bilimleri University
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 Progressive Muscle Relaxation Exercise in people with Anxiety and Stress, 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 4 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 9 Sep 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?
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?
Anxiety (time frame: Change from baseline in 1 week). 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 NCT04540172, 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 9 Sep 2020.