Mindfulness-Based Emotion Regulation Training for Hospitalized Children

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.

Study Overview

• Status: Recruiting
• Conditions: Fear; Child, Only; Hospitalism in Children
• Intervention / Treatment: Behavioral: training

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Erzurum, Turkey (Türkiye)
    • Recruiting
    • Ataturk University Nursing of Faculty
    • Contact: ARZU SARIALIOGLU; Phone Number: 04422315795; Email: arzu.celebi@atauni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: training; 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.	Behavioral: training; In addition to routine nursing care, children in the intervention group will receive the 'Mindfulness-Based Emotion Regulation Training Programme' developed by the researcher.
No Intervention: control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 30.2.ATA.0.01.00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No