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Therapeutic PlayNCT06845111

Therapeutic Play and Its Effect on Children's Psychosocial Well-Being

A study testing Therapeutic play in people with Therapeutic Play and Psychosocial Well-being, run by Kocaeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to evaluate the effectiveness of the Therapeutic Play-Based Intervention Programme (TOTEM), which was developed to reduce the negative psychosocial effects of the earthquake in children aged 4-6 years, and its effect on children's psychosocial well-being. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
What is being tested?
Therapeutic play
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2024to 1 Dec 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 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Being between the ages of 4-6
  • Having literate parents
  • Having adequate Turkish receptive-expressive language skills
  • Not having a previously diagnosed psychiatric problem declared by the parents
  • Not having participated in a training programme on psychosocial well-being before
  • Not attending any pre-school education institution at the time of the training
  • Volunteering to participate in the study by themselves and their parents

Who cannot join

  • The participant wants to leave the study
  • The participant has not participated in one or more of the trainings to be given within the scope of the programme
  • The participant shows any diagnosed atypical development
  • Children who show a level of resistance that disrupts their adaptation to normal life in pre-tests, during the study or in post-tests, children with anxiety disorder or other psychiatric problems

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kocaeli University

    Kocaeli, Izmit, 41001

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Therapeutic Play-Based Intervention Programme (TOTEM) Applied to 4-6 Age Group Earthquake Victims Living in Kahramanmaraş on Children's Psychosocial Well-Being

The aim of this study was to evaluate the effectiveness of the Therapeutic Play-Based Intervention Programme (TOTEM), which was developed to reduce the negative psychosocial effects of the earthquake in children aged 4-6 years, and its effect on children's psychosocial well-being.

Read the detailed description

Earthquakes are among the most impressive geological processes and are defined as an unpredictable natural disaster due to their destructive effects on people and structures. In Turkey, a 7.7-magnitude earthquake occurred on 6 February 2023 at 04.17 local time, centred in Kahramanmaraş, and another 7.6-magnitude earthquake occurred about nine hours later. In addition, more than 1000 aftershocks were recorded in the region and these events further increased the scale of the disaster. Earthquakes have the potential to have profound and traumatic effects on people's psychological functioning. Children are particularly affected by these effects due to their vulnerability during natural disasters. Children who experience disasters may face various problems in physical, cognitive and socio-emotional development.

Therapeutic play intervention is based on the belief that play is a universal language that allows children to easily express their feelings and thoughts. This approach is an effective strategy that helps the child to explore their problems, seek solutions, express their feelings and emotional regulation. It also promotes cognitive development, reduces anxiety and stress, and increases confidence.

Providing appropriate support to children after a traumatic event such as an earthquake is critical for preventing future psychological problems. In this context, providing children with supportive approaches such as play therapy and conducting these methods by expert teams can contribute to children's well-being. Therapeutic games play an important role by providing a universal language for children to express their emotions and cope with stress.

Being tested
Therapeutic play
Keywords
Child, anxiety, psychosocial status, disturbance, nursing care
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic playOther

    In this context, the pre-school teachers in the container area were contacted and the sessions were held every Wednesday-Thursday (8 sessions in total) for 5 weeks, taking into account their availability hours. Children were included in the programme in groups of 12. Before data collection, the necessary materials were provided and stored in an empty container. It was found appropriate to complete the trainings in kindergartens located in the container city (4). A total of 3 evaluations were carried out: a post-test immediately after the end of the programme and a retention test at the end of the first month.

Study groups in NCT06845111
Study groupRoleWhat they receive
Experimental: Group receiving Therapeutic PlayExperimentalThe Therapeutic Play-Based Intervention Programme (TOTEM) designed for the research was carried out with the children in the intervention group on the determined days and hours. The children were administered the post-test immediately after the end of the programme and then the retention test at the end of the first month.
Receives: Other: Therapeutic play
Control GroupNo interventionControl group (routine education programme): The children in the control group were administered a pre-test in the kindergartens they were currently attending (which were included in daily routine life, games, etc. by preschool teachers living in the city), a post-test after five weeks in parallel with the study group, and then a retention test at the end of the first month. Considering ethical principles, the TOTEM programme was also applied to the children in this group after the study was completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Scale in Preschool Children

    The Anxiety Scale in Preschool Children (Spence et al., 2001) developed by Spence, Rapee, McDonald, Ingram (2001) was adapted into Turkish by Şahin (2020). While the original scale had 28 items measuring social anxiety, separation anxiety, fear of physical injury, general anxiety and obsessive-compulsive disorder, Şahin added 5 items related to post-traumatic stress disorder while adapting it to Turkish and validity and reliability studies were conducted with these items. The scale is a 5-point scale and each item is scored between 0 and 4. A total score can be obtained from the scale. A high score on the scale indicates that anxiety in preschool children is high, while a low score indicates that anxiety in preschool children is low. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.93 (Şahin, 2020). For this study, Cronbach's Alpha coefficient was calculated as 0.91.

    Measured: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

  2. Psychosocial Status Assessment Scale for 3-6 Year Old Children (Parent Form)

    Psychosocial Situation Rating Scale (PSRS) was developed by Güneş-Şan and Altay and is a measurement tool consisting of 31 items that measures Psychosocial Situation Rating based on parental report in children aged 3-6 years. For each item in the PSDD, there are 5-point Likert type options 0-'never', 1-'rarely', 2-'sometimes', 3-"often", 4-'always'. Based on the score given for each item, a minimum score of '0' and a maximum score of '124' can be obtained from the questionnaire. A low total score indicates that there is no risk for psychosocial problems in the child, while a high score indicates that there is a risk for psychosocial problems. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.83 and test-retest reliability was calculated as 0.957 (Güneş-Şan \& Altay, 2021). For this study, Cronbach's Alpha coefficient was calculated as 0.88.

    Measured: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

  3. Sleep Disturbance Scale for Children

    The scale developed by Bruni et al. (1996) was adapted into Turkish and the validity and reliability study was conducted by Ağça-Bilmenoğlu (2019). The scale developed to investigate sleep disorders in children consists of 26 items and each question is scored between 1-5. The measurement tool includes questions measuring sleep initiation and maintenance problems, sleep breathing disorders, sleep-wake disorders, sleep-wake transition disorders, excessive sleepiness disorders and excessive sweating during sleep. The scores that can be obtained from the scale vary between 26 and 130, and high scores are interpreted as a high degree of sleep disorder. Within the scope of the reliability of the scale, Cronbach's Alpha coefficient was calculated as 0.84 and test-retest reliability as 0.79 (Ağça-Bilmenoğlu, 2019). For this study, Cronbach's Alpha coefficient was calculated as 0.85.

    Measured: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 May 2024
  3. Primary completion1 Sep 2024
  4. Study completion1 Dec 2024

Resources

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
Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845111
Sponsor's protocol ID
2023/15/15
Other IDs
123S913
Status last verified
May 2024
First submitted
20 Feb 2025
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park EJ, Lee MS, Bae SM, Kim HS, Hong M, Kim E, Lee SK, Kim J, Bhang SY. Promising Effect of the Children in Disaster: Evaluation and Recovery Intervention on Trauma Symptoms and Quality of Life for Children and Adolescents: A Controlled Study. Psychiatry Investig. 2024 Feb;21(2):123-132. doi: 10.30773/pi.2023.0202. Epub 2024 Feb 8.

    PubMed 38321890

  • Wong CL, Ip WY, Kwok BMC, Choi KC, Ng BKW, Chan CWH. Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. BMJ Open. 2018 Jul 5;8(7):e021071. doi: 10.1136/bmjopen-2017-021071.

    PubMed 29980545

  • Juwita, H. 2019. "Effectiveness of multimodal interventions play therapy: Colouring and origami against anxiety levels in toddler ages," Journal of Health Science and Prevention, 3(3S), 46-51.

  • Silva, L., Oliveira, C., Oliveira, J., Bandeira, P., Matos, J., Gomes, E., et al. 2022. "Use of therapeutic play in nursing care for school-age children: a scoping review," Preprints (2022).

  • Satapathy S, Dang S, Sagar R, Dwivedi SN. Resilience in Children and Adolescents Survived Psychologically Traumatic Life Events: A Critical Review of Application of Resilience Assessment Tools for Clinical Referral and Intervention. Trauma Violence Abuse. 2022 Jan;23(1):288-300. doi: 10.1177/1524838020939126. Epub 2020 Jul 23.

    PubMed 32700641

  • Bratton, S., Ray, D., Rhine, T., & Jones, L. 2005. "The Efficacy of Play Therapy With Children: A Meta-Analytic Review of Treatment Outcomes," Professional Psychology: Research and Practice, 36, 376-390.

  • Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.

    PubMed 33711642

  • Nursanaa, W., Ady, I. 2020. "Play Therapy for Children with Anxiety Disorders," Proceedings of Social Sciences & Humanities, 81-86.

  • Gülmez, İ., & Karaaziz, M. 2023. "A systematic review on the use of play therapy in sexually abused children," The Journal of Social Sciences, 62(62), 450-466.

  • Leblanc, M., & Ritchie, M. 2001. "A meta-analysis of play therapy outcomes," Counselling Psychology Quarterly, 14, 149-163.

  • Humble JJ, Summers NL, Villarreal V, Styck KM, Sullivan JR, Hechler JM, Warren BS. Child-Centered Play Therapy for Youths Who Have Experienced Trauma: a Systematic Literature Review. J Child Adolesc Trauma. 2018 Nov 9;12(3):365-375. doi: 10.1007/s40653-018-0235-7. eCollection 2019 Sep.

    PubMed 32318206

  • Ray, D. C., & Armstrong, S. A. 2021. "Child-centered play therapy: A review of research and practice," International Journal of Play Therapy, 30(1), 1-12.

  • Topal S, Caka SY, Uysal G, Alabay E, Demir Y, Arslan SC. The effect of therapeutic play-based intervention programme applied to earthquake victim preschool children on psychosocial well-being: a randomised controlled trial. BMC Psychol. 2025 Aug 29;13(1):981. doi: 10.1186/s40359-025-03317-4.

    PubMed 40883789

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic play in people with Therapeutic Play and Psychosocial Well-being, run by Kocaeli 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 7 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: finished, as of the sponsor's last update on 21 Nov 2025. 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?

Anxiety Scale in Preschool Children (time frame: A total of 3 evaluations will be made: before the programme starts, the post-test immediately after the end of the programme and the retention test at the end of the first month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845111, which also lists 13 linked publications.

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 21 Nov 2025.

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