AlexithymiaNCT06701097
Emotion Regulation Training, Nursing Student, and Alexithymia
A study testing Emotion regulation training in people with Alexithymia and Emotion Regulation, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alexithymia, Emotion Regulation
- What is being tested?
- Emotion regulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2023to 28 Jun 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be a student of the nursing department
- Agree to participate in the study
Who cannot join
- Having received psychological support within the last 10 years
- Having a psychiatric disorder
- Not being a citizen of the Republic of Turkey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Emotion Regulation Training on the Levels of Alexithymia in Nursing College Students
This study aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students.
Read the detailed description
This study aimed to reduce alexithymia levels in nursing students with emotion regulation training based on a cognitive behavioral approach. The study was conducted with 74 nursing students, 37 in the intervention group and 37 in the control group, studying at a foundation university in the 2023-2024 academic year. The study data were collected using the data collection form and the Toronto Alexithymia Scale-20 (TAS-20). Data collection tools were applied three times as pre-post and follow-up tests. Male and female students who met the inclusion criteria of the study were determined by using the pre-test of the population. For the sample group to represent the population, students with high levels of alexithymia were identified by stratification by determining the class and gender ratios. Then, students were assigned to intervention and control groups by randomization. The 7-session training program prepared for the students in the intervention group was applied. No intervention was made to the control group during the implementation. After the training sessions were completed, post-test data were collected. Follow-up measurements were made three months later.
- Conditions
- Alexithymia, Emotion Regulation
- Being tested
- Emotion regulation training
- Keywords
- Alexithymia, Nursing, Emotion regulation, Student
- Medical subject headings
- Affective Symptoms, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion regulation trainingBehavioural
Man is a social being and therefore interacts with his environment. In the process of interaction, they can transfer their feelings, thoughts, and information. However, the interaction process may not always continue smoothly. People's inability to express their emotions appropriately today negatively affects communication. The reason why people cannot express their emotions may be the high level of alexithymia. The concept of alexithymia means having difficulty in recognizing, expressing, and naming emotions. High levels of alexithymia in students, who are future healthcare professionals, can negatively affect themselves, other healthcare professionals and the patients they care for; it can cause burnout in healthcare professionals, decrease the quality of care they provide and cause them to experience interpersonal communication conflicts.
| Study group | Role | What they receive |
|---|---|---|
| Emotion regulation training group | Experimental | Since the number of participants in the intervention group would prevent the training from being given as a group, the participants were divided into three different groups. Each group was given theoretical training on emotions, thoughts, physical symptoms resulting from emotions, and verbal and non-verbal ways of communicating emotions. The theoretical training was reinforced with activities such as relaxation exercises, role plays, imagination, brainstorming, etc. Each training lasted 60-90 minutes. Receives: Behavioral: Emotion regulation training |
| Control group | No intervention | Participants in the control group did not receive any training. Only pre-test, post-test, and follow-up tests were applied to the individuals in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Alexithymia-20 Scale
The scale measures the alexithymia level of the individual. The scale is a Likert-type scale consisting of 20 items and scored between 1-5. The minimum score that can be obtained from the scale is 20 and the maximum score is 100. The higher the score obtained from the scale, the higher the alexithymia level of the individual.
Measured: - Before training. -immediately after the training is over. -Three months after training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Oct 2023
- Primary completion23 Dec 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlexithymiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Günay Öge, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701097
- Sponsor's protocol ID
- E.60365
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotion Regulation Training on the Levels of Alexithymia in Nursing College Students
- ClinicalTrials.gov ID
- NCT06701097
- Acronym / sponsor ID
- E.60365
- Conditions
- Alexithymia, Emotion Regulation
- Keywords
- Alexithymia, Nursing, Emotion regulation, Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 22 Nov 2024 (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 aimed to investigate the effects of emotional regulation training, which is a prepared based on the cognitive behavioral approach, on alexithymia in nursing students.
Detailed description
This study aimed to reduce alexithymia levels in nursing students with emotion regulation training based on a cognitive behavioral approach. The study was conducted with 74 nursing students, 37 in the intervention group and 37 in the control group, studying at a foundation university in the 2023-2024 academic year. The study data were collected using the data collection form and the Toronto Alexithymia Scale-20 (TAS-20). Data collection tools were applied three times as pre-post and follow-up tests. Male and female students who met the inclusion criteria of the study were determined by using the pre-test of the population. For the sample group to represent the population, students with high levels of alexithymia were identified by stratification by determining the class and gender ratios. Then, students were assigned to intervention and control groups by randomization. The 7-session training program prepared for the students in the intervention group was applied. No intervention was made to the control group during the implementation. After the training sessions were completed, post-test data were collected. Follow-up measurements were made three months later.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion regulation training group | Experimental | Behavioral: Emotion regulation trainingSince the number of participants in the intervention group would prevent the training from being given as a group, the participants were divided into three different groups. Each group was given theoretical training on emotions, thoughts, physical symptoms resulting from emotions, and verbal and non-verbal ways of communicating emotions. The theoretical training was reinforced with activities such as relaxation exercises, role plays, imagination, brainstorming, etc. Each training lasted 60-90 minutes. |
| Control group | No intervention | –Participants in the control group did not receive any training. Only pre-test, post-test, and follow-up tests were applied to the individuals in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- To be a student of the nursing department
- Agree to participate in the study
Key exclusion criteria (3 listed)
- Having received psychological support within the last 10 years
- Having a psychiatric disorder
- Not being a citizen of the Republic of Turkey
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 |
|---|---|---|
| Emotion regulation trainingMan is a social being and therefore interacts with his environment. In the process of interaction, they can transfer their feelings, thoughts, and information. However, the interaction process may not always continue smoothly. People's inability to express their emotions appropriately today negatively affects communication. The reason why people cannot express their emotions may be the high level of alexithymia. The concept of alexithymia means having difficulty in recognizing, expressing, and naming emotions. High levels of alexithymia in students, who are future healthcare professionals, can negatively affect themselves, other healthcare professionals and the patients they care for; it can cause burnout in healthcare professionals, decrease the quality of care they provide and cause them to experience interpersonal communication conflicts. | Behavioural | Emotion regulation training group |
Primary outcome
Toronto Alexithymia-20 Scale
Time frame: - Before training. -immediately after the training is over. -Three months after training.
The scale measures the alexithymia level of the individual. The scale is a Likert-type scale consisting of 20 items and scored between 1-5. The minimum score that can be obtained from the scale is 20 and the maximum score is 100. The higher the score obtained from the scale, the higher the alexithymia level of the individual.
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 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion regulation training in people with Alexithymia and Emotion Regulation, run by Ankara Medipol 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 2 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 2024. 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?
Toronto Alexithymia-20 Scale (time frame: - Before training. -immediately after the training is over. -Three months after training.). 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 2024.