FearNCT07379021
Mindfulness-Based Emotion Regulation Training for Hospitalized Children
A study testing training in people with Fear and Child, Only, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Hospitalization and medical procedures are a significant source of stress and anxiety for school-age children aged 7-11, who, due to their cognitive development, can perceive events but lack the capacity to cope effectively. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear, Child, Only, Hospitalism in Children
- What is being tested?
- training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2025to 26 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be aged between 7 and 11 years old,
- Have a planned hospital stay of at least four days,
- Be able to speak and understand Turkish,
- Be able to read and write (to complete questionnaires),
- The child and parent must be willing to participate in the study.
Who cannot join
- The child has a hearing/speech problem that prevents them from communicating,
- The child has severe pain or acute respiratory distress that prevents them from participating,
- The child has a known psychiatric diagnosis,
- The child has previously received similar mindfulness training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Nursing of Faculty
Erzurum
ARZU SARIALIOGLU, 04422315795, arzu.celebi@atauni.edu.tr
About this study
Official title: The Effect of Mindfulness-Based Emotion Regulation Training on Fear and Emotion Regulation in Hospitalized Children
Hospitalization and medical procedures are a significant source of stress and anxiety for school-age children aged 7-11, who, due to their cognitive development, can perceive events but lack the capacity to cope effectively. The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.
Read the detailed description
The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.
Control Group: Children in the control group will not receive any mindfulness training from the researcher; only the clinic's routine nursing care and treatment procedures will be applied.
- T1 (Pre-test): Scales will be administered on the first day of admission, prior to routine care.
- T2 (Post-Test): Scales will be administered again on the 5th day of hospitalisation to complete data collection. Completing the forms will take an average of 15-20 minutes.
Intervention Group: Children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher in addition to routine nursing care.
- T1 (Pre-test): Scales will be administered on the first day of admission, before the first training session.
- Application: For 5 consecutive days, once a day, structured sessions (breathing exercises, emotion recognition, body scan, etc.), each lasting approximately 20 minutes, will be conducted in the child's own room with tablet/visual material support and under the guidance of the researcher. During the application, the quietness of the environment and the child's attention will be maintained in a standard manner.
- T2 (Post Test): At the end of the 5th day (after the final session), the scales will be re-administered to evaluate the programme's effectiveness. Completing the forms will take an average of 15-20 minutes.
- Conditions
- Fear, Child, Only, Hospitalism in Children
- Being tested
- training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
In addition to routine nursing care, children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| training | Experimental | In addition to routine nursing care, children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher.
* T1 (Pre-test): On the first day of admission, the scales will be administered before the first training session.
* Application: For 5 consecutive days, once a day, structured sessions (breathing exercises, emotion recognition, body scan, etc.), each lasting approximately 20 minutes, will be conducted in the child's own room with tablet/visual material support and under the guidance of a researcher. During the application, the quietness of the environment and the child's attention will be maintained in a standard manner.
* T2 (Post Test): At the end of the 5th day (after the final session), the scales will be re-administered to evaluate the programme's effectiveness. Completing the forms will take an average of 15-20 minutes. Receives: Behavioral: training |
| control | No intervention | Children in the control group will not receive any mindfulness training from the researcher; only the clinic's routine nursing care and treatment procedures will be applied. * T1 (Pre-test): Scales will be administered on the first day of admission, prior to routine care. * T2 (Post-Test): Scales will be administered again on the 5th day of hospitalisation to complete data collection. Completing the forms will take an average of 15-20 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation Scale for Children and Adolescents:
The scale was adapted by Gullone and Taffe (2012) from the Emotion Regulation Scale developed by Gross and John (2003) for an adult sample. The scale was adapted into Turkish by Tetik and Önder in 2021. The scale is a self-assessment tool designed to evaluate differences in the use of two emotion regulation strategies. The scale includes statements such as 'I control my emotions by not showing them.' The scale consists of 'two subscales, reappraisal and suppression, and 10 items.' The assessment is conducted using a 5-point Likert-type rating scale. Items 1, 3, 5, 7, 8, and 10 represent the reappraisal subscale, while items 2, 4, 6, and 9 represent the suppression subscale. High scores on the subscales indicate frequent use of the emotion regulation strategy represented by that subscale. The Cronbach's alpha internal consistency coefficient ranged from .82 to .86 for the reappraisal subscale and from .69 to .79 for the suppression subscale.
Measured: 1 year
Medical Procedure Fear Scale
Developed by Marion Bloom et al. in 1985, this scale measures children's fears related to medical procedures and treatments. The validity and reliability study of the scale in Turkey was conducted by Alak (1993). The scale contains items such as 'I am afraid the doctor will hurt me' and 'I am afraid of going to the hospital' and is a 3-point Likert scale (0 = Never, 1 = Sometimes, 2 = Very much). Medical fears are addressed in 29 questions. The scale consists of four sub-dimensions. The Cronbach's alpha for the scale was found to be 0.93. The minimum score obtainable from the scale is 29, and the maximum score is 87. An increase in score indicates an increase in medical fear.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start26 Dec 2025
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379021
- Sponsor's protocol ID
- 30.2.ATA.0.01.00
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Emotion Regulation Training on Fear and Emotion Regulation in Hospitalized Children
- ClinicalTrials.gov ID
- NCT07379021
- Acronym / sponsor ID
- 30.2.ATA.0.01.00
- Conditions
- Fear, Child, Only, Hospitalism in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 30 Jan 2026 (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.
Hospitalization and medical procedures are a significant source of stress and anxiety for school-age children aged 7-11, who, due to their cognitive development, can perceive events but lack the capacity to cope effectively. The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.
Detailed description
The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.
Control Group: Children in the control group will not receive any mindfulness training from the researcher; only the clinic's routine nursing care and treatment procedures will be applied.
- T1 (Pre-test): Scales will be administered on the first day of admission, prior to routine care.
- T2 (Post-Test): Scales will be administered again on the 5th day of hospitalisation to complete data collection. Completing the forms will take an average of 15-20 minutes.
Intervention Group: Children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher in addition to routine nursing care.
- T1 (Pre-test): Scales will be administered on the first day of admission, before the first training session.
- Application: For 5 consecutive days, once a day, structured sessions (breathing exercises, emotion recognition, body scan, etc.), each lasting approximately 20 minutes, will be conducted in the child's own room with tablet/visual material support and under the guidance of the researcher. During the application, the quietness of the environment and the child's attention will be maintained in a standard manner.
- T2 (Post Test): At the end of the 5th day (after the final session), the scales will be re-administered to evaluate the programme's effectiveness. Completing the forms will take an average of 15-20 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Experimental | Behavioral: trainingIn addition to routine nursing care, children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher. * T1 (Pre-test): On the first day of admission, the scales will be administered before the first training session. * Application: For 5 consecutive days, once a day, structured sessions (breathing exercises, emotion recognition, body scan, etc.), each lasting approximately 20 minutes, will be conducted in the child's own room with tablet/visual material support and under the guidance of a researcher. During the application, the quietness of the environment and the child's attention will be maintained in a standard manner. * T2 (Post Test): At the end of the 5th day (after the final session), the scales will be re-administered to evaluate the programme's effectiveness. Completing the forms will take an average of 15-20 minutes. |
| control | No intervention | –Children in the control group will not receive any mindfulness training from the researcher; only the clinic's routine nursing care and treatment procedures will be applied. * T1 (Pre-test): Scales will be administered on the first day of admission, prior to routine care. * T2 (Post-Test): Scales will be administered again on the 5th day of hospitalisation to complete data collection. Completing the forms will take an average of 15-20 minutes. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be aged between 7 and 11 years old,
- Have a planned hospital stay of at least four days,
- Be able to speak and understand Turkish,
- Be able to read and write (to complete questionnaires),
- The child and parent must be willing to participate in the study.
Key exclusion criteria (4 listed)
- The child has a hearing/speech problem that prevents them from communicating,
- The child has severe pain or acute respiratory distress that prevents them from participating,
- The child has a known psychiatric diagnosis,
- The child has previously received similar mindfulness training
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 |
|---|---|---|
| trainingIn addition to routine nursing care, children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher. | Behavioural | training |
Primary outcome
Emotion Regulation Scale for Children and Adolescents:
Time frame: 1 year
The scale was adapted by Gullone and Taffe (2012) from the Emotion Regulation Scale developed by Gross and John (2003) for an adult sample. The scale was adapted into Turkish by Tetik and Önder in 2021. The scale is a self-assessment tool designed to evaluate differences in the use of two emotion regulation strategies. The scale includes statements such as 'I control my emotions by not showing them.' The scale consists of 'two subscales, reappraisal and suppression, and 10 items.' The assessment is conducted using a 5-point Likert-type rating scale. Items 1, 3, 5, 7, 8, and 10 represent the reappraisal subscale, while items 2, 4, 6, and 9 represent the suppression subscale. High scores on the subscales indicate frequent use of the emotion regulation strategy represented by that subscale. The Cronbach's alpha internal consistency coefficient ranged from .82 to .86 for the reappraisal subscale and from .69 to .79 for the suppression subscale.
Medical Procedure Fear Scale
Time frame: 1 year
Developed by Marion Bloom et al. in 1985, this scale measures children's fears related to medical procedures and treatments. The validity and reliability study of the scale in Turkey was conducted by Alak (1993). The scale contains items such as 'I am afraid the doctor will hurt me' and 'I am afraid of going to the hospital' and is a 3-point Likert scale (0 = Never, 1 = Sometimes, 2 = Very much). Medical fears are addressed in 29 questions. The scale consists of four sub-dimensions. The Cronbach's alpha for the scale was found to be 0.93. The minimum score obtainable from the scale is 29, and the maximum score is 87. An increase in score indicates an increase in medical fear.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Fear and Child, Only, run by Ataturk 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Scale for Children and Adolescents: (time frame: 1 year). 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 30 Jan 2026.