AngerNCT04174040
Process Model of Emotion Regulation Integrated Musical Rhythm Interventions' Effects on Student Nurses' Anger
A study testing Gross's Process of Emotion Regulation Model Interventions, Musical Rhythm Interventions and Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions in people with Anger, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study aims to determine the effect of the anger management program to be implemented by integrating the rhythm component of music with the Gross Process Model of Emotion Regulation on the anger expression and anger types of nursing students determined to be under risk through screenings. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Anger
- What is being tested?
- Gross's Process of Emotion Regulation Model Interventions, Musical Rhythm Interventions and Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2018to 21 Jun 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 20 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be a third year student in the Faculty of Nursing
- To have a higher score than the average limits calculated according to the State Anger score to be obtained from all students,
- Willingness and volunteering for a musical practice
Who cannot join
- To benefit from regular psychological counseling in the last three months,
- To have a professional music education,
- To have a physical handicap that will affect musical sense and skill.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gross' Process Model of Emotion Regulation Integrated in Musical Rhythm Interventions on Student Nurses' Anger Expressions and States
Aim: The study aims to determine the effect of the anger management program to be implemented by integrating the rhythm component of music with the Gross Process Model of Emotion Regulation on the anger expression and anger types of nursing students determined to be under risk through screenings.
Materials and Methods: This single-blind factorial designed randomized experimental research was conducted with three control groups. The study group consisted of third-grade students (N=67) who were determined to have scores above average from The State-Trait Anger Expression Inventory (STAXI). The study data were collected with pre-post tests and follow-up measurements using STAXI. The experimental interventions were completed in five sessions after pilot study with a specialist. The data were analyzed using one-way and two-way variance analyses (4x3 Factorial ANOVA). Effect size was measured with ε^2.
Read the detailed description
Introduction: Nursing students' anger regulation functionally has increasingly gained importance. It is known that cognitive behavioral approaches and music can be used as effective tools for young adults. It is important that the rhythm component of music be integrated with the Gross Model of Emotion Regulation, which analyzes the emotional regulation processes on a cognitive-behavioral basis, and new interventional tools be developed, which can be regularly and easily accessed in psychiatric nursing. The study results will shed light on future studies in terms of using the Gross Model, integrated in musical rhythm studies, to manage functional anger in student nurses.
Aim: The study aims to determine the effect of the anger management program to be implemented by integrating the rhythm component of music with the Gross Model of Emotion Regulation on the anger expression and anger types of nursing students determined to be under risk through screenings.
Materials and Methods: This single-blind factorial designed randomized experimental research was conducted with three control groups. The study group consisted of third-grade students (N=67) who were enrolled in Ege University Faculty of Nursing and determined to have scores above average from The State-Trait Anger Expression Inventory (STAXI). The study data were collected from 38 students who met the inclusion criteria. They were collected with pre-post tests and follow-up measurements using STAXI and introductory information form developed in light of the literature. The Gross Model of Emotion Regulation intervention program, integrated with musical rhythms, was completed in five sessions after pilot study. The sessions in the musical rhythms were carried out in company with a specialist. The data were analyzed using one-way and two-way variance analyses (4x3 Factorial ANOVA). The statistical significance level was measured with p˂0.05, and effect size was measured with ε^2. Ethical permissions were obtained to conduct the study.
- Conditions
- Anger
- Being tested
- Gross's Process of Emotion Regulation Model Interventions, Musical Rhythm Interventions, Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions
- Keywords
- music, Cognitive Behavioral Therapy, randomized controlled trial, rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross's Process of Emotion Regulation Model InterventionsBehavioural
Interventions were based on Gross's Process Model which include the basis concepts of cognitive-behavioral therapy and carried on with five semi-structured sessions. Cognitive-behavioral theories accept the existence of a thought process (attention-perception-interpretation) that appears in the mind about the event just before the anger emerges. Therefore, anger studies with cognitive-behavioral approach generally proceed with the steps of gaining awareness about this concealed thought, identifying behavioral response and avoidance attitudes and thus regulating emotion. It consists of five 90-minute group sessions structured in this context. While being an accredited cognitive behavioral therapist, investigator have qualified to manage these approach.
The effectiveness of these semi-structured sessions were evaluated by using:
- Pretest application of STAXI
- Taking feedback after each intervention session
- Posttest application of STAXI
- Follow-up test application of STAXI
Musical Rhythm InterventionsBehavioural
This musical group rhythm intervention was continued with 90 minute long five sessions. The students participated in the practice together with a music expert and lead researcher. The lead researcher took on the role of observer in these sessions. Each session was continued with warming, improvisation and targeted semi-structured rhythm practices aiming anger regulation. The effectiveness of these semi-structured sessions were evaluated by using:
- Pretest application of STAXI
- Taking feedback after each intervention session
- Posttest application of STAXI
- Follow-up test application of STAXI
Musical Rhythm Integrated Gross's Emotion Regulation Process InterventionsBehavioural
The students participated in the practice together with a music expert and lead researcher. The lead researcher ensured the integration of rhythm applications into the Process Model through cognitive-behavioral semi-structured interventions. Five semi-structured 90-minute group sessions were performed. The effectiveness of the experiment was evaluated by using:
- Pretest application of STAXI
- Taking feedback after each intervention session
- Posttest application of STAXI
- Follow-up test application of STAXI
| Study group | Role | What they receive |
|---|---|---|
| Control 1 | No intervention | Applied any intervention. |
| Control 2 | Active comparator | Gross's Process of Emotion Regulation Model interventions applied. Receives: Behavioral: Gross's Process of Emotion Regulation Model Interventions |
| Control 3 | Active comparator | Musical rhythm interventions applied. Receives: Behavioral: Musical Rhythm Interventions |
| Experimental | Experimental | Musical rhythm integrated Gross's Process of Emotion Regulation Model interventions applied. Receives: Behavioral: Gross's Process of Emotion Regulation Model Interventions; Behavioral: Musical Rhythm Interventions; Behavioral: Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anger State and Anger Expressions (first evaluation with posttest)
Anger state and expressions were evaluated with using The State-Trait Anger Expression Inventory. This scale originally organized by Charles D. Spielberger in 1988. The scale, which evaluated trait anger (10 items) and state anger behavior (24 items), was adapted to Turk society by Özer N. in 1992. This tool was used to diagnose anger severity and behavioral reactions of anger in many national studies in child, adolescent and adult groups. Scale's Trait Anger dimension (anger expressions) were separated in three subscales as 'anger out', 'anger in' and 'anger control' which each includes eight items (subscale total score min:8, max:32). State Anger subscale has 10 items and total score range is between 10-40 points.
Measured: Through study completion, an average of 4 months
Anger State and Anger Expressions (second evaluation with follow up)
Anger state and expressions were evaluated with using The State-Trait Anger Expression Inventory.
Measured: Through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start21 Mar 2018
- Primary completion21 May 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngerStudies of the same condition, open and under way.
- More trials run by Ege 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- One experimental and three control groups involved study model.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Beycan Ekitli, PhD., Ege University
- Investigators
- Gizem Beycan Ekitli, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174040
- Sponsor's protocol ID
- EgeTrial
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gross' Process Model of Emotion Regulation Integrated in Musical Rhythm Interventions on Student Nurses' Anger Expressions and States
- ClinicalTrials.gov ID
- NCT04174040
- Acronym / sponsor ID
- EgeTrial
- Conditions
- Anger
- Keywords
- music, Cognitive Behavioral Therapy, randomized controlled trial, rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 22 Nov 2019 (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.
Aim: The study aims to determine the effect of the anger management program to be implemented by integrating the rhythm component of music with the Gross Process Model of Emotion Regulation on the anger expression and anger types of nursing students determined to be under risk through screenings.
Materials and Methods: This single-blind factorial designed randomized experimental research was conducted with three control groups. The study group consisted of third-grade students (N=67) who were determined to have scores above average from The State-Trait Anger Expression Inventory (STAXI). The study data were collected with pre-post tests and follow-up measurements using STAXI. The experimental interventions were completed in five sessions after pilot study with a specialist. The data were analyzed using one-way and two-way variance analyses (4x3 Factorial ANOVA). Effect size was measured with ε^2.
Detailed description
Introduction: Nursing students' anger regulation functionally has increasingly gained importance. It is known that cognitive behavioral approaches and music can be used as effective tools for young adults. It is important that the rhythm component of music be integrated with the Gross Model of Emotion Regulation, which analyzes the emotional regulation processes on a cognitive-behavioral basis, and new interventional tools be developed, which can be regularly and easily accessed in psychiatric nursing. The study results will shed light on future studies in terms of using the Gross Model, integrated in musical rhythm studies, to manage functional anger in student nurses.
Aim: The study aims to determine the effect of the anger management program to be implemented by integrating the rhythm component of music with the Gross Model of Emotion Regulation on the anger expression and anger types of nursing students determined to be under risk through screenings.
Materials and Methods: This single-blind factorial designed randomized experimental research was conducted with three control groups. The study group consisted of third-grade students (N=67) who were enrolled in Ege University Faculty of Nursing and determined to have scores above average from The State-Trait Anger Expression Inventory (STAXI). The study data were collected from 38 students who met the inclusion criteria. They were collected with pre-post tests and follow-up measurements using STAXI and introductory information form developed in light of the literature. The Gross Model of Emotion Regulation intervention program, integrated with musical rhythms, was completed in five sessions after pilot study. The sessions in the musical rhythms were carried out in company with a specialist. The data were analyzed using one-way and two-way variance analyses (4x3 Factorial ANOVA). The statistical significance level was measured with p˂0.05, and effect size was measured with ε^2. Ethical permissions were obtained to conduct the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- One experimental and three control groups involved study model.
| Arm | Type | Receives |
|---|---|---|
| Control 1 | No intervention | –Applied any intervention. |
| Control 2 | Active comparator | Behavioral: Gross's Process of Emotion Regulation Model InterventionsGross's Process of Emotion Regulation Model interventions applied. |
| Control 3 | Active comparator | Behavioral: Musical Rhythm InterventionsMusical rhythm interventions applied. |
| Experimental | Experimental | Behavioral: Gross's Process of Emotion Regulation Model Interventions, Behavioral: Musical Rhythm Interventions, Behavioral: Musical Rhythm Integrated Gross's Emotion Regulation Process InterventionsMusical rhythm integrated Gross's Process of Emotion Regulation Model interventions applied. |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To be a third year student in the Faculty of Nursing
- To have a higher score than the average limits calculated according to the State Anger score to be obtained from all students,
- Willingness and volunteering for a musical practice
Key exclusion criteria (3 listed)
- To benefit from regular psychological counseling in the last three months,
- To have a professional music education,
- To have a physical handicap that will affect musical sense and skill.
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 |
|---|---|---|
| Gross's Process of Emotion Regulation Model InterventionsInterventions were based on Gross's Process Model which include the basis concepts of cognitive-behavioral therapy and carried on with five semi-structured sessions. Cognitive-behavioral theories accept the existence of a thought process (attention-perception-interpretation) that appears in the mind about the event just before the anger emerges. Therefore, anger studies with cognitive-behavioral approach generally proceed with the steps of gaining awareness about this concealed thought, identifying behavioral response and avoidance attitudes and thus regulating emotion. It consists of five 90-minute group sessions structured in this context. While being an accredited cognitive behavioral therapist, investigator have qualified to manage these approach. The effectiveness of these semi-structured sessions were evaluated by using: 1. Pretest application of STAXI 2. Taking feedback after each intervention session 3. Posttest application of STAXI 4. Follow-up test application of STAXI | Behavioural | Control 2, Experimental |
| Musical Rhythm InterventionsThis musical group rhythm intervention was continued with 90 minute long five sessions. The students participated in the practice together with a music expert and lead researcher. The lead researcher took on the role of observer in these sessions. Each session was continued with warming, improvisation and targeted semi-structured rhythm practices aiming anger regulation. The effectiveness of these semi-structured sessions were evaluated by using: 1. Pretest application of STAXI 2. Taking feedback after each intervention session 3. Posttest application of STAXI 4. Follow-up test application of STAXI | Behavioural | Control 3, Experimental |
| Musical Rhythm Integrated Gross's Emotion Regulation Process InterventionsThe students participated in the practice together with a music expert and lead researcher. The lead researcher ensured the integration of rhythm applications into the Process Model through cognitive-behavioral semi-structured interventions. Five semi-structured 90-minute group sessions were performed. The effectiveness of the experiment was evaluated by using: 1. Pretest application of STAXI 2. Taking feedback after each intervention session 3. Posttest application of STAXI 4. Follow-up test application of STAXI | Behavioural | Experimental |
Primary outcome
Anger State and Anger Expressions (first evaluation with posttest)
Time frame: Through study completion, an average of 4 months
Anger state and expressions were evaluated with using The State-Trait Anger Expression Inventory. This scale originally organized by Charles D. Spielberger in 1988. The scale, which evaluated trait anger (10 items) and state anger behavior (24 items), was adapted to Turk society by Özer N. in 1992. This tool was used to diagnose anger severity and behavioral reactions of anger in many national studies in child, adolescent and adult groups. Scale's Trait Anger dimension (anger expressions) were separated in three subscales as 'anger out', 'anger in' and 'anger control' which each includes eight items (subscale total score min:8, max:32). State Anger subscale has 10 items and total score range is between 10-40 points.
Anger State and Anger Expressions (second evaluation with follow up)
Time frame: Through study completion, an average of 7 months
Anger state and expressions were evaluated with using The State-Trait Anger Expression Inventory.
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 22 Nov 2019.
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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.
Gizem Beycan Ekitli, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gross's Process of Emotion Regulation Model Interventions, Musical Rhythm Interventions and Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions in people with Anger, run by Ege 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 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 22 Nov 2019. 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?
Anger State and Anger Expressions (first evaluation with posttest) (time frame: Through study completion, an average of 4 months). The study lists 2 primary outcomes in all. 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 22 Nov 2019.