CancerNCT06368947
Therapeutic Play on Pain Tolerance and Emotion Regulation in Children
A study testing Therapeutic Play in people with Cancer, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Therapeutic Play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2024to 29 Sep 2026
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 10-18
- Diagnosed with acute lymphoblastic leukemia
- Those receiving chemotherapy treatment
- Children who do not have a chronic disease other than the diagnosis of the disease in question
Who cannot join
- Under 10 years of age or over 18 years of age
- Diagnosed other than acute lymphoblastic leukemia
- Not receiving chemotherapy treatment
- Children with chronic diseases other than the diagnosis of the disease in question
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, Erzurum, 25240
ARZU SARIALİOĞLU, PHD, 04422315795, arzu.celebi@atauni.edu.tr
About this study
Official title: Therapeutic Play on Pain Tolerance and Emotion Regulation in Children Receiving Chemotherapy
The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment.
Read the detailed description
Type of Research: The research is a randomized controlled experimental study. Place and Time of the Research: The research will be carried out at the Pediatric Hematology Clinic of Adana City Training and Research Hospital between April 2024 and June 2026.
Population and Sample of the Research: The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. In this study, G-power prior power analysis was performed to determine the sample size. In the power analysis, it was determined that if the study was conducted with a total of 60 participants in two groups with 30 participants in each group for the t test in independent groups, 80% power could be achieved with a 95% confidence interval at a significance level of 0.05. It was decided to collect data from a total of 66 children by including a 10% backup sample in this number in case of data loss.
Therapeutic game: In the research, a preliminary application will be made first. A special play bag will be created for each child patient, which will not threaten his health and can be disinfected. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. Therapeutic game 2 days a week for a maximum of 60 minutes. It will be carried out for 4 weeks.
Week 1: It will consist of meeting, building trust, giving information about the sessions, and planning the therapeutic game. After the initial meeting and trust building stages, activities will be held with emotion cards. Week 2: The researcher will carry out activities that will enable the child to express his emotions through puppet making. A puppet with the characteristics desired by the child will be made by the child and the researcher. The shape and appearance of the puppet will be determined by the child.
Week 3: At this stage, after the puppet is completed, the drama will be created and realized through the meaning given to the puppet and the emotions reflected. Emotions will be discussed on the puppet, and the child will be helped to understand, express and analyze his feelings.
Week 4: The child and the researcher will produce creative stories and the child's emotions will be discussed. In the last sessions of this stage, the child will be comforted by using the "healing stories for children" book.
Evaluation of Data The data will be analyzed with the SPSS for Windows 22 package program. The normality distribution of the data will be determined by Kurtosis and Skewness coefficients. In the analysis of the data, in addition to numbers, percentages, averages and standard deviations, t-test will be used in independent groups for normally distributed measurements and Mann Whitney U analysis will be used for non-normally distributed measurements in comparing paired groups. Statistical significance will be accepted as p<0.05.
Ethical Principles of Research In order to conduct the research, official permission was obtained from the relevant institution with ethical approval from the Ataturk University Non-Interventional Clinical Research Ethics Committee. Clinical trials will be registered for randomized controlled studies. The purpose of the study will be explained to children and parents who meet the research group criteria, their questions will be answered, and their verbal and written consent will be obtained. Children and parents will be informed that the data collected during the research will be processed confidentially and anonymously, will not be used outside of the study in question, and that they can leave the study at any time. Since the research is based on the use of data obtained from humans, and therefore the need to respect personal rights, the relevant ethical principles of "Informed Consent", "Volunteering" and "Protection of Confidentiality" will be followed. The "Principle of Equality" will be tried to be fulfilled by giving the children in the control group the same game bags given to the children in the intervention group.
- Conditions
- Cancer
- Being tested
- Therapeutic Play
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic PlayBehavioural
Therapeutic play sessions will be organized twice a week for 4 weeks during chemotherapy treatment for children diagnosed with acute lymphoblastic leukemia in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Therapeutic play sessions will be organized twice a week for 4 weeks during chemotherapy treatment for children diagnosed with acute lymphoblastic leukemia in the intervention group. Receives: Behavioral: Therapeutic Play |
| control | No intervention | Routine treatment will be applied to children in the control group receiving chemotherapy during their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance Scale for Children with Cancer
The scale was created to develop a tool to measure psychological acceptance in children experiencing pain during cancer treatment. The test version of the scale was conducted on children between the ages of 7 and 18 who were receiving cancer treatment. The Turkish reliability and validity study of the scale was conducted and it was found suitable for use in Turkish children with cancer. The scale is a 7-point Likert type scale consisting of 20 items (0 = strongly disagree and 6 = strongly agree). Some items in the scale (1, 2, 3, 5, 6, 7, 8, 9, 11, 13, 14, 15, 16, 18, 20 items) are reverse coded. The minimum score to be obtained from the scale is 0 and the maximum score is 120. Increasing scale scores indicate an increase in the level of acceptance.
Measured: 12 months
Emotion Regulation Scale for Children and Adolescents
The scale was adapted to Turkish in 2021. The scale is a self-rating scale created to evaluate the differences in the use of two emotion regulation strategies. The scale consists of two subscales, reappraisal and suppression, and 10 items. Evaluation is made with a 5-point Likert type rating. Items 1, 3, 5, 7, 8, and 10 of the reevaluation subscale; Items 2, 4, 6, and 9 represent the suppression subscale. High scores obtained from the subscales indicate that the emotion regulation strategy represented by the subscale is frequently used.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start29 Apr 2024
- Primary completion29 Dec 2024
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 66 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
- NCT06368947
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/172
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Play on Pain Tolerance and Emotion Regulation in Children Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT06368947
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/172
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 16 Apr 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.
The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment.
Detailed description
Type of Research: The research is a randomized controlled experimental study. Place and Time of the Research: The research will be carried out at the Pediatric Hematology Clinic of Adana City Training and Research Hospital between April 2024 and June 2026.
Population and Sample of the Research: The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. In this study, G-power prior power analysis was performed to determine the sample size. In the power analysis, it was determined that if the study was conducted with a total of 60 participants in two groups with 30 participants in each group for the t test in independent groups, 80% power could be achieved with a 95% confidence interval at a significance level of 0.05. It was decided to collect data from a total of 66 children by including a 10% backup sample in this number in case of data loss.
Therapeutic game: In the research, a preliminary application will be made first. A special play bag will be created for each child patient, which will not threaten his health and can be disinfected. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. Therapeutic game 2 days a week for a maximum of 60 minutes. It will be carried out for 4 weeks.
Week 1: It will consist of meeting, building trust, giving information about the sessions, and planning the therapeutic game. After the initial meeting and trust building stages, activities will be held with emotion cards. Week 2: The researcher will carry out activities that will enable the child to express his emotions through puppet making. A puppet with the characteristics desired by the child will be made by the child and the researcher. The shape and appearance of the puppet will be determined by the child.
Week 3: At this stage, after the puppet is completed, the drama will be created and realized through the meaning given to the puppet and the emotions reflected. Emotions will be discussed on the puppet, and the child will be helped to understand, express and analyze his feelings.
Week 4: The child and the researcher will produce creative stories and the child's emotions will be discussed. In the last sessions of this stage, the child will be comforted by using the "healing stories for children" book.
Evaluation of Data The data will be analyzed with the SPSS for Windows 22 package program. The normality distribution of the data will be determined by Kurtosis and Skewness coefficients. In the analysis of the data, in addition to numbers, percentages, averages and standard deviations, t-test will be used in independent groups for normally distributed measurements and Mann Whitney U analysis will be used for non-normally distributed measurements in comparing paired groups. Statistical significance will be accepted as p<0.05.
Ethical Principles of Research In order to conduct the research, official permission was obtained from the relevant institution with ethical approval from the Ataturk University Non-Interventional Clinical Research Ethics Committee. Clinical trials will be registered for randomized controlled studies. The purpose of the study will be explained to children and parents who meet the research group criteria, their questions will be answered, and their verbal and written consent will be obtained. Children and parents will be informed that the data collected during the research will be processed confidentially and anonymously, will not be used outside of the study in question, and that they can leave the study at any time. Since the research is based on the use of data obtained from humans, and therefore the need to respect personal rights, the relevant ethical principles of "Informed Consent", "Volunteering" and "Protection of Confidentiality" will be followed. The "Principle of Equality" will be tried to be fulfilled by giving the children in the control group the same game bags given to the children in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Therapeutic PlayTherapeutic play sessions will be organized twice a week for 4 weeks during chemotherapy treatment for children diagnosed with acute lymphoblastic leukemia in the intervention group. |
| control | No intervention | –Routine treatment will be applied to children in the control group receiving chemotherapy during their treatment. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Between the ages of 10-18
- Diagnosed with acute lymphoblastic leukemia
- Those receiving chemotherapy treatment
- Children who do not have a chronic disease other than the diagnosis of the disease in question
Key exclusion criteria (4 listed)
- Under 10 years of age or over 18 years of age
- Diagnosed other than acute lymphoblastic leukemia
- Not receiving chemotherapy treatment
- Children with chronic diseases other than the diagnosis of the disease in question
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 |
|---|---|---|
| Therapeutic PlayTherapeutic play sessions will be organized twice a week for 4 weeks during chemotherapy treatment for children diagnosed with acute lymphoblastic leukemia in the intervention group. | Behavioural | intervention |
Primary outcome
Pain Tolerance Scale for Children with Cancer
Time frame: 12 months
The scale was created to develop a tool to measure psychological acceptance in children experiencing pain during cancer treatment. The test version of the scale was conducted on children between the ages of 7 and 18 who were receiving cancer treatment. The Turkish reliability and validity study of the scale was conducted and it was found suitable for use in Turkish children with cancer. The scale is a 7-point Likert type scale consisting of 20 items (0 = strongly disagree and 6 = strongly agree). Some items in the scale (1, 2, 3, 5, 6, 7, 8, 9, 11, 13, 14, 15, 16, 18, 20 items) are reverse coded. The minimum score to be obtained from the scale is 0 and the maximum score is 120. Increasing scale scores indicate an increase in the level of acceptance.
Emotion Regulation Scale for Children and Adolescents
Time frame: 12 months
The scale was adapted to Turkish in 2021. The scale is a self-rating scale created to evaluate the differences in the use of two emotion regulation strategies. The scale consists of two subscales, reappraisal and suppression, and 10 items. Evaluation is made with a 5-point Likert type rating. Items 1, 3, 5, 7, 8, and 10 of the reevaluation subscale; Items 2, 4, 6, and 9 represent the suppression subscale. High scores obtained from the subscales indicate that the emotion regulation strategy represented by the subscale is frequently used.
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 22 Jan 2026.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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 Therapeutic Play in people with Cancer, 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 4 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 22 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?
Pain Tolerance Scale for Children with Cancer (time frame: 12 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 Jan 2026.