NCT05475938

Brief Summary

In the population suffering from cancer, children and teenagers are in the majority. For children with rapid development of body and mind, with the change of cognitive ability, they will feel anxiety and fear about the expected potential negative events. Painting art therapy is a kind of non-verbal psychological therapy through the interaction between the painter, the painting work and the therapist, with the painting creation activity as the intermediary. The purpose is to develop symbolic language, touch the inner subconscious, and integrate into the personality, so as to produce cognitive and behavioral changes. Painting therapy and psychological analysis can improve the treatment compliance of children bone tumor patients, make psychological nursing and health education of patients more targeted, and promote the cooperation between medical care and patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 24, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Psychological distress thermometer

    The significance of psychological distress is identified according to the score

    Up to approximately 2months

  • Anxiety Screening Form for Children (SCARED)

    It consists of 41 items and 5 factors (somatization/panic, generalized anxiety, dissociative anxiety, social phobia and school phobia). The scale is divided into 3 levels (0 points: none; 1 mark: Sometimes. 2 marks: quite often. SCARED score ≥23 is positive, that is, the presence of anxiety.

    Up to approximately 2months

Study Arms (2)

Analysis of painting

EXPERIMENTAL

Pathologically confirmed children with malignant bone tumors, painting therapists to explain the requirements and purpose of painting. After the patient completes the painting, the therapist makes a targeted and individualized analysis and provides psychological counseling by reflecting the patient's psychological state through painting.

Other: Painting therapy and psychoanalysis

Psychological treatment

EXPERIMENTAL

After the patient completes the painting, the therapist makes a targeted and individualized analysis and provides psychological counseling by reflecting the patient's psychological state through painting.

Other: Painting therapy and psychoanalysis

Interventions

Pathologically confirmed children with malignant bone tumors, painting therapists to explain the requirements and purpose of painting. After the patient completes the painting, the therapist makes a targeted and individualized analysis and provides psychological counseling by reflecting the patient's psychological state through painting.

Analysis of paintingPsychological treatment

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 7-16
  • No gender limitation
  • Pathologically confirmed patients with osteosarcoma and Ewing's sarcoma
  • Have painting ability

You may not qualify if:

  • Those who do not cooperate
  • Family members or patients reject this treatment technique
  • The patient has severe intellectual disability;
  • The patient's condition is in critical stage or bone marrow suppression stage or complicated with serious complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Psychoanalysis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

PsychiatryBehavioral SciencesBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimental group underwent psychological evaluation, drawing analysis and psychotherapy intervention before and after chemotherapy and surgery, while the control group only underwent psychological evaluation without drawing analysis and psychotherapy intervention.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 27, 2022

Study Start

October 20, 2021

Primary Completion

May 5, 2022

Study Completion

May 5, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations