PainNCT06508632
The Effect of Mandala on Nausea, Vomiting, Pain and Anxiety in Chemotherapy Patients
A study testing Mandala group in people with Pain and Anxiety, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children receiving outpatient chemotherapy. The concept of cancer is used to describe a group of diseases that start from a single cell and show uncontrolled growth, proliferation and spread to surrounding tissues. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- What is being tested?
- Mandala group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 31 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being at the pediatric chemotherapy clinic to receive outpatient chemotherapy
- Receiving daily chemotherapy
- Those who agreed to participate in the research
- Mother and child must know Turkish
- The child knows colors
Who cannot join
- Having a mental health problem (preventing the use of Mandala therapy coloring technique)
- Having a disability that prevents you from seeing or using your hand (a condition that prevents you from using the Mandala therapy coloring technique)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University Balcalı Training and Research Hospital
Adana, Balçalı, 01250
About this study
Official title: The Effect of Mandala Art Therapy (Coloring) on Nausea, Vomiting, Pain and Anxiety in Children Receiving Outpatient Chemotherapy
To determine the effect of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children receiving outpatient chemotherapy. The concept of cancer is used to describe a group of diseases that start from a single cell and show uncontrolled growth, proliferation and spread to surrounding tissues. The cooperation of the family and the healthcare team plays a major role in the success of the treatment. Surgical treatment, radiotherapy and chemotherapy are applied in its treatment. Art therapy, a method of distraction, is used to prevent pediatric oncology patients from focusing on the pain and stressful life events they experience. By having children do artistic activities in the hospital room, nurses can reduce symptom management, social isolation, and long-term negative social effects.
Read the detailed description
Cancer treatment in children is determined according to the type of cancer, its stage and the child's general health condition. Treatment options include the following; chemotherapy, radiotherapy, surgery, immunotherapy and targeted therapy. The following problems are observed in children receiving chemotherapy in the short and long term: fever, fatigue, weight loss, pain, fatigue, anxiety, nausea and vomiting, changes in sleep and mood. 91% of oncology patients have benefited from Complementary and Alternative Medicine (CAM), such as art, to improve their general health, and painting, painting, music and dance, and mind-body therapies have been shown to have positive effects on the quality of life in pediatric oncology patients.
Art therapy in the pediatric oncology patient population. The American Art Therapy Association (AATA) (2013) defines art therapy as healing. Increasing the physical, mental and emotional well-being of individuals is considered as creative interventions of art production. These interventions have been widely used as alternative treatments for a variety of conditions, including cancer.
Although there is a significant amount of research on the effects of art therapies, there is a lack of research in the existing literature regarding their specific effects on symptoms such as nausea, vomiting, pain, and anxiety. However, the effects on quality of life are generally given more attention.
Among the art therapies; Mandala art therapy is a type of art therapy using circular patterns and symbols. In this therapy, participants explore their inner world and express their emotions by creating their own mandates. It gives individuals the opportunity to concretize the complex and abstract thoughts in their minds caused by their painful experiences. Emotions and thoughts are spontaneously embedded in artistic products such as sculpture, music, painting, marbling and mandala. Mandala therapy improves creativity and problem-solving skills by increasing emotional awareness and expression.
As a result, mandala art therapy can be used in the treatment of many different problems such as stress, anxiety, depression, trauma and chronic disease, as well as in the management of symptoms.
To determine the sample size of the study, the power of the study was calculated with the G-Power 3.1.9.2 program using the confidence interval and effect size parameters. 80% power, 95% confidence interval and effect size of 0.5 or more. In the G-Power 3.1.9.2 program, the total sample size was calculated as 48 (24+24) based on 0.05 significance, 0.80 large effect and 80% power. However, considering the 10% loss and taking into account the parametric test assumption, the sample number of each group was determined as 30 people in the intervention group and 30 people in the control group, for a total of 60 people.
- Being tested
- Mandala group
- Keywords
- Mandala Art Therapy, Child, Nausea Vomiting, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala groupBehavioural
Also called Control group
Individual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication. Children will color (paint).
| Study group | Role | What they receive |
|---|---|---|
| Experimantal group | Experimental | Individual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication. Receives: Behavioral: Mandala group |
| Control Group | No intervention | In this study, the control group will receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating scale
It is a visual analog scale used to evaluate the intensity of pain. This scale includes six different facial expressions scored from 0 to 10. 0 means "no pain," while 10 means "most severe pain." The scale is used to diagnose pain in children aged 3-18. Pain scores are given according to the numerical values given to the faces on the scale. The lowest score is "1" and the highest score is "5". As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases.
Measured: Approximately 2 hours from start
Secondary outcomes (1)
Nausea and Vomiting Thermometer in Children with Cancer
The Nausea and Vomiting Thermometer Scale in Children with Cancer is a tool used to evaluate the frequency and severity of nausea and vomiting in children with cancer aged 0-18 years. The structure of the scale consists of 2 subscales: Nausea: 0 (no nausea) - 10 (most severe nausea), Vomiting: 0 (no vomiting) - 10 (most severe vomiting), Visuals using 5 different colors and emojis for each subscale. A thermometer was created.
Measured: Approximately 2 hours from start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start15 Apr 2024
- Primary completion15 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Model description
- Experimental, randomised controlled, single-blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahri AŞKAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508632
- Sponsor's protocol ID
- F ASKAN
- Status last verified
- Jan 2025
- First submitted
- 8 Jul 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Art Therapy (Coloring) on Nausea, Vomiting, Pain and Anxiety in Children Receiving Outpatient Chemotherapy
- ClinicalTrials.gov ID
- NCT06508632
- Acronym / sponsor ID
- F ASKAN
- Keywords
- Mandala Art Therapy, Child, Nausea Vomiting, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jul 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.
To determine the effect of mandala art therapy (coloring) on nausea, vomiting, pain and anxiety in children receiving outpatient chemotherapy. The concept of cancer is used to describe a group of diseases that start from a single cell and show uncontrolled growth, proliferation and spread to surrounding tissues. The cooperation of the family and the healthcare team plays a major role in the success of the treatment. Surgical treatment, radiotherapy and chemotherapy are applied in its treatment. Art therapy, a method of distraction, is used to prevent pediatric oncology patients from focusing on the pain and stressful life events they experience. By having children do artistic activities in the hospital room, nurses can reduce symptom management, social isolation, and long-term negative social effects.
Detailed description
Cancer treatment in children is determined according to the type of cancer, its stage and the child's general health condition. Treatment options include the following; chemotherapy, radiotherapy, surgery, immunotherapy and targeted therapy. The following problems are observed in children receiving chemotherapy in the short and long term: fever, fatigue, weight loss, pain, fatigue, anxiety, nausea and vomiting, changes in sleep and mood. 91% of oncology patients have benefited from Complementary and Alternative Medicine (CAM), such as art, to improve their general health, and painting, painting, music and dance, and mind-body therapies have been shown to have positive effects on the quality of life in pediatric oncology patients.
Art therapy in the pediatric oncology patient population. The American Art Therapy Association (AATA) (2013) defines art therapy as healing. Increasing the physical, mental and emotional well-being of individuals is considered as creative interventions of art production. These interventions have been widely used as alternative treatments for a variety of conditions, including cancer.
Although there is a significant amount of research on the effects of art therapies, there is a lack of research in the existing literature regarding their specific effects on symptoms such as nausea, vomiting, pain, and anxiety. However, the effects on quality of life are generally given more attention.
Among the art therapies; Mandala art therapy is a type of art therapy using circular patterns and symbols. In this therapy, participants explore their inner world and express their emotions by creating their own mandates. It gives individuals the opportunity to concretize the complex and abstract thoughts in their minds caused by their painful experiences. Emotions and thoughts are spontaneously embedded in artistic products such as sculpture, music, painting, marbling and mandala. Mandala therapy improves creativity and problem-solving skills by increasing emotional awareness and expression.
As a result, mandala art therapy can be used in the treatment of many different problems such as stress, anxiety, depression, trauma and chronic disease, as well as in the management of symptoms.
To determine the sample size of the study, the power of the study was calculated with the G-Power 3.1.9.2 program using the confidence interval and effect size parameters. 80% power, 95% confidence interval and effect size of 0.5 or more. In the G-Power 3.1.9.2 program, the total sample size was calculated as 48 (24+24) based on 0.05 significance, 0.80 large effect and 80% power. However, considering the 10% loss and taking into account the parametric test assumption, the sample number of each group was determined as 30 people in the intervention group and 30 people in the control group, for a total of 60 people.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental, randomised controlled, single-blind study
| Arm | Type | Receives |
|---|---|---|
| Experimantal group | Experimental | Behavioral: Mandala groupIndividual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication. |
| Control Group | No intervention | –In this study, the control group will receive standard care. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being at the pediatric chemotherapy clinic to receive outpatient chemotherapy
- Receiving daily chemotherapy
- Those who agreed to participate in the research
- Mother and child must know Turkish
- The child knows colors
Key exclusion criteria (2 listed)
- Having a mental health problem (preventing the use of Mandala therapy coloring technique)
- Having a disability that prevents you from seeing or using your hand (a condition that prevents you from using the Mandala therapy coloring technique)
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 |
|---|---|---|
| Mandala groupAlso: Control groupIndividual mandala activity will be carried out in all sample groups after admission to the clinic where they come to receive outpatient chemotherapy and when they start taking medication. Children will color (paint). | Behavioural | Experimantal group |
Primary outcome
Pain Rating scale
Time frame: Approximately 2 hours from start
It is a visual analog scale used to evaluate the intensity of pain. This scale includes six different facial expressions scored from 0 to 10. 0 means "no pain," while 10 means "most severe pain." The scale is used to diagnose pain in children aged 3-18. Pain scores are given according to the numerical values given to the faces on the scale. The lowest score is "1" and the highest score is "5". As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases.
1 secondary outcome
Nausea and Vomiting Thermometer in Children with Cancer
Time frame: Approximately 2 hours from start
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 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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 Mandala group in people with Pain and Anxiety, run by Cukurova 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 5 inclusion and 2 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 23 Jan 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?
Pain Rating scale (time frame: Approximately 2 hours from start). 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 23 Jan 2025.