Therapeutic Play on Pain Tolerance and Emotion Regulation in Children

NCT06368947 | Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/172
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Study Arms (2)

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.

Behavioral: Therapeutic Play

control

NO INTERVENTION

Routine treatment will be applied to children in the control group receiving chemotherapy during their treatment.

Interventions

Therapeutic Play BEHAVIORAL

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.

intervention

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Erzurum, 25240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Play Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: April 29, 2024
• Primary Completion: December 29, 2024
• Study Completion (Estimated): September 29, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)