Therapeutic Communication Techniques for Children Aged 7-12 in Intensive Care

August 11, 2025 updated by: Özge Köksal, Uşak University

The Ethical Approval From Gazi University Has Been Obtained.The Institutional Approval From Bilkent City Hospital Has Been Obtained.

Summary of the Research Children may need to stay in intensive care for a period of time due to acute or chronic illnesses in their lives.There may be anxiety, fear and concerns in intensive care. Therefore, a healthy communication with the child, such as care, accurate transfer and reporting of the events and situations experienced according to the development level, the use of appropriate therapeutic communication, the child's mental and spiritual life includes all lives. The aim of this study is to examine the effects of therapeutic communication techniques applied to the 7-12 age groups in intensive care on the emotional development of children. The research will be patterned later. The research storage will consist of 70 children between the ages of 7-12 who are hospitalized in the Intensive Care Unit of Ankara Bilkent City Hospital Pediatric Intensive Care Unit and Uşak University Education and Research Hospital. Data will be collected with 1. Descriptive Data Form Related to the Child and Family, 2. State Anxiety Inventory, 3. Koppitz's Human Figure Drawing Test, 4. "Facial Expressions Rating Scale" in Wong and Baker.

Purpose of the study: The purpose of this study is to examine the effects of therapeutic communication techniques applied to children aged 7-12 in intensive care on the emotional state of the children.

Hypotheses of the Study:

H1.1: The average total score of the state anxiety scale in the intervention group (children receiving therapeutic communication techniques) will differ from that of the control group (children not receiving therapeutic communication techniques).

H1.2: The emotional state of the children in the intervention group, as measured by the Koppitz Human Figure Drawing Test, will differ from the emotional state of children in the control group.

Before the therapeutic communication method is applied to the children in the intervention and control groups, the descriptive characteristics data form, the State Anxiety Inventory, the Facial Expressions Rating Scale, and the Emotion Wheel will be applied.

The forms will be shown to the child by the researcher at the child's bedside in the intensive care unit and filled out face to face by the researcher. After the therapeutic communication intervention is completed, Koppitz's Human Figure Drawing Test and State Anxiety Inventory will be applied to the children in the intervention and control groups. The estimated application time of the forms is 30 minutes. The application will last 2 days.

DAY 1: Application of joint storytelling as a therapeutic communication technique by the researcher to the children DAY 2: Application of picture drawing technique as a therapeutic communication technique by the researcher to the children

Study Overview

Detailed Description

Study Design: study is designed as a randomized controlled trial to evaluate the effects of therapeutic communication techniques on the emotional development of children aged 7-12 in intensive care units.

Participants:

The study will include 70 children aged 7-12 years who are admitted to the Pediatric Intensive Care Units of Ankara Bilkent City Hospital and Uşak University Training and Research Hospital.

Randomization:To reduce selection bias and control for variables that may affect outcome parameters, participants will be randomly assigned to either the intervention group, which will receive therapeutic communication techniques, or the control group, which will receive standard care.In order to ensure homogeneity between groups, it will be created with the existing stratification method.The CONSORT 2022 (Updated Guidelines for Reporting Randomized Parallel Group Trials) report will be followed during the randomization phase The data obtained in the study will be evaluated in the computer environment with the SPSS 27.0 package data program. The conformity of the data to normal distribution will be examined with descriptive statistics (skewness, kurtosis), hypothesis tests (Kolmogorov-Smirnov/Shapiro-Wilk tests) and visually (histogram and probability graphs). In comparisons between groups, single-factor covariance analysis (ANCOVA) will be applied to eliminate bias in normally distributed data, and Mann Whitney U test will be applied for non-normally distributed data. In intra-group evaluations, the significance test of the difference between two pairs will be used for normally distributed ordinal data, and the Wilcoxon paired two-sample test will be used for non-normally distributed ones. Chi-square test will be used in comparisons of nominal data between groups.

Ethical Aspects of the Research A permit numbered 09 dated 12.07.2024 was obtained from the Gazi University Ethics Committee for the implementation of the data collection forms. Written consent will be obtained from the patient child and his/her family to be included in the study, and the identity and medical conditions of the participants will be kept confidential. The children in the control group will be subjected to the technique of drawing pictures and telling stories after the study.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Merkez
      • Uşak, Merkez, Turkey
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Aged between 7 and 12 years,

Receiving treatment in an intensive care unit,

Children and families who agree to participate in the study,

Conscious with a Glasgow Coma Scale (GCS) score of 15,

First-time experience in an intensive care unit,

Able to speak and understand Turkish,

Not experiencing intense symptoms such as pain or nausea during the procedure,

Children monitored at levels 1 and 2 will be included.

Exclusion Criteria

The child has a chronic illness requiring frequent hospitalizations and treatment,

The child has a medically diagnosed psychological disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Communication Techniques
Participants in the intervention group will participate in therapeutic communication sessions using storytelling and drawing techniques for 2 days.
Therapeutic communication techniques will be applied to children in the intensive care unit for two days."
No Intervention: Standard Care
The control group will receive standard care. After the study is completed, therapeutic communication techniques will also be applied to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory
Time Frame: Before and immediately after the application of therapeutic communication techniques."
The State-Trait Anxiety Inventory is a psychological inventory that measures the level of anxiety in individuals. It consists of two separate scales: one that measures state anxiety (the temporary anxiety experienced at a specific moment or situation) and one that measures trait anxiety (the general tendency to experience anxiety in a variety of situations).It was developed to assess how children feel at that moment. It consists of 20 items and aims to assess feelings related to state anxiety. The options in this form are scored as "not at all" (1), "a little" (2), "a lot" (3), "always" (4). The highest score that can be obtained from the State Anxiety Inventory is 80 and the lowest score is 20. A high score indicates a high anxiety state. A low score indicates a low anxiety state.
Before and immediately after the application of therapeutic communication techniques."

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Serhat Emeksiz, Assoc. Prof., Bilkent City Hospital
  • Study Director: Ebru Kılıçarslan, Professor, Gazi Univercıty
  • Principal Investigator: Özge Köksal, Research Assistant, Uşak Univercıty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

January 26, 2025

Study Completion (Actual)

January 26, 2025

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: Research
    Information comments: There is no additional information."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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