Bone TumorsNCT05475938
Application of Painting Analysis and Psychotherapy in Children With Bone Tumors
A study testing Painting therapy and psychoanalysis in people with Bone Tumors, run by Henan Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Bone Tumors
- What is being tested?
- Painting therapy and psychoanalysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 5 May 2022
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 7-16
- No gender limitation
- Pathologically confirmed patients with osteosarcoma and Ewing's sarcoma
- Have painting ability
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: Application of Painting Analysis and Psychotherapy in the Nursing of Children Bone Tumor
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.
Read the detailed description
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. Forty pediatric bone tumor patients meeting the requirements were selected from the bone and soft tissue ward of our hospital. Twenty subjects were randomly divided into experimental group and control group. 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. This experiment was designed to evaluate the change of psychological state of children after intervention. To verify whether the intervention has improved the psychological and cognitive aspects of the children.
- Conditions
- Bone Tumors
- Being tested
- Painting therapy and psychoanalysis
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Painting therapy and psychoanalysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Painting therapy and psychoanalysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress thermometer
The significance of psychological distress is identified according to the score
Measured: 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.
Measured: Up to approximately 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start20 Oct 2021
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorsStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liuxin, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475938
- Sponsor's protocol ID
- LHGJ20200165
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Painting Analysis and Psychotherapy in the Nursing of Children Bone Tumor
- ClinicalTrials.gov ID
- NCT05475938
- Acronym / sponsor ID
- LHGJ20200165
- Conditions
- Bone Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 27 Jul 2022 (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.
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.
Detailed description
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. Forty pediatric bone tumor patients meeting the requirements were selected from the bone and soft tissue ward of our hospital. Twenty subjects were randomly divided into experimental group and control group. 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. This experiment was designed to evaluate the change of psychological state of children after intervention. To verify whether the intervention has improved the psychological and cognitive aspects of the children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Analysis of painting | Experimental | Other: Painting therapy and psychoanalysisPathologically 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. |
| Psychological treatment | Experimental | Other: Painting therapy and psychoanalysisAfter 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 7-16
- No gender limitation
- Pathologically confirmed patients with osteosarcoma and Ewing's sarcoma
- Have painting ability
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Painting therapy and psychoanalysisPathologically 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 | Analysis of painting, Psychological treatment |
Primary outcome
Psychological distress thermometer
Time frame: Up to approximately 2months
The significance of psychological distress is identified according to the score
Anxiety Screening Form for Children (SCARED)
Time frame: Up to approximately 2months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Painting therapy and psychoanalysis in people with Bone Tumors, run by Henan Cancer Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 29 Jul 2022. 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 China. 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?
Psychological distress thermometer (time frame: Up to approximately 2months). 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 29 Jul 2022.