NursingNCT04297982
Mandala Activity and Adolescents With Cancer
A study testing Mandala Activity and Routine nursing care in people with Nursing, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to determine the effect of mandala activity on adolescents receiving cancer treatment on psychological symptoms and anxiety/depression level. Method: The study was conducted as a randomized controlled experimental study with adolescents aged 12-17 years receiving cancer treatment in… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing
- What is being tested?
- Mandala Activity and Routine nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 15 Jul 2020
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be able to read and speak Turkish
- Clinical diagnosis of cancer disease
- The ages of 12-17.
- The duration of diagnosis is at least 2 months
- Must be have cancer treatment,
Who cannot join
- The patient is in the terminal period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Activity on Psychological Symptoms, Anxiety and Depression Level of Adolescents Receiving Cancer Treatment
Aim: The aim of this study is to determine the effect of mandala activity on adolescents receiving cancer treatment on psychological symptoms and anxiety/depression level.
Method: The study was conducted as a randomized controlled experimental study with adolescents aged 12-17 years receiving cancer treatment in Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample group was composed of 30 adolescents in the experimental group and 30 adolescents in the control group using the closed envelope system in accordance with the selection criteria of the sample. The experimental group was given 2 sessions of mandala drawing and staining activity with music at least 48 hours apart. In the study, individual activity was preferred. In each session, adolescents were allowed to draw and stain a mandala. 'Data Collection Form' before the first session, 'Memorial Symptom Assessment Scale', ''Hospital Anxiety and Depression Scale were applied to the experimental group before and after the first session. The same data collection tools were applied to the control group at 48 hours intervals without any activity.
Read the detailed description
Type of the Study This research; This is a randomized controlled experimental study to determine whether mandala activity applied to adolescents receiving cancer treatment has an effect on psychological symptoms and anxiety / depression level.
Place and Time of the Study The research was carried out in Antalya Akdeniz University Hospital, Child Hematology / Oncology Clinic. The research data were collected by the researcher between March 2019 and February 2020. Akdeniz University Child Hematology and Oncology Clinic is a 32-bed institution where children between 0-18 years old receive inpatient treatment and care. It is forbidden to visit the clinic to protect patients from infection, thereby providing a calm environment in the clinic. The rooms are double and single.
Mandala activity at a normal room temperature (average 25 ° C), in terms of being bright enough and a comfortable environment for adolescents; It was planned to have a room that was spacious, clean, with a window opening (not opening to the corridor) and in sunlight, and it was decided that the most suitable environment in the clinic was the patient's own room.
Sample of the Research The sampling of the study was composed of all adolescents who received cancer treatment in Akdeniz University Hospital Child Hematology / Oncology Clinic. Adolescents who accepted to participate in the study on a voluntary basis and having the inclusion criteria constituted the sample of the study. The sample group was formed in accordance with the sample selection criteria and divided into two as experimental and control groups. As a result of the power analysis, the sample group with 80% power and 0.05 error margin; The experimental group 30 and the control group 30 were planned to form a total of 60 children receiving cancer treatment.
Data Collection Tools In this study; Two scales were used for the descriptive features of the Personal Information Form, Memorial Symptom Evaluation Scale Psychological Sub-Dimension (MSDÖ-P) and Hospital Anxiety and Depression Scale (Adolescent Age Group Form).
Prior to the research, permission was obtained from the Antalya Akdeniz University Clinical Research Ethics Committee regarding the method and design of the study (Decision No: 492, Date: 11.07.2018). After obtaining the approval of the ethics committee, necessary verbal and written permissions were obtained from Akdeniz University Hospital. Permission was obtained to use the Memorial Symptom Assessment Scale, which was adapted to Turkish for children aged 10-18 by Atay in 2008, validity and reliability study. Permission was obtained via e-mail to use the Hospital Anxiety and Depression Scale, which was validated for validity and reliability in the adolescent age group by Erkan in 2014.
Before starting the study, it was explained to the adolescent about the purpose, duration, fee of the research, all information will be kept confidential and will not be used anywhere other than the thesis. In addition, informed consent was obtained from the adolescent by explaining that there will be no difficulty in participating in the study and that the study is based on volunteering, and that they can leave whenever they want during the application phase. Before the application of the research, the parent was informed about the research in written or verbally. The researcher attended mandala education before the thesis study.
Mandala Activity (İnterventation Group) Scales were applied to the experimental group in the first encounter with the adolescent (pre-test). One day later, one session of individual mandala activity were performed. Later at least 48 hours, also one session of individual mandala activity. Each adolescent created two seans mandala and freely drawn and painted the unstructured mandala on white paper, starting from the center and expanding. A day after the second session mandala activity the same scales were reapplied last (post-test).
Control Group Scales were applied to the control group with an interval of 5 days and received routine nursing care (pre-test, post-test).
Mandala Activity Application Steps
- Researchers ensured that the patient is not in times such as sleep or meal time.
- The best time for the activity was determined by exchanging ideas with the patient.
- Hygienic rules were taken care of (Washing hands and wiping the materials with alcohol cotton).
- A comfortable environment has been provided for activities (the room is bright enough, closing the room door to prevent noise, lifting the back of the bed with the patient in a sitting position, and adjusting the height of the table brought in front of the patient).
- Sample videos on how to draw mandala were watched before the application.
- Adolescents were told that the beauty of the drawings was not important, as the mandala is a means of expression and sharing.
- In the individual mandala activity, the drawings were made with classical / instrumental music.
- It was provided to paint and then paint before painting from the center on the picture paper without disturbing the order.
- When created mandala, all the drawings and paintings were made inside the circles drawn together.
- Adolescents are free to choose colors and shapes during the individual mandala activity.
- Unless the adolescents asked for help, the researcher did not intervene in the mandala drawing
- Conditions
- Nursing
- Being tested
- Mandala Activity, Routine nursing care
- Keywords
- cancer, adolescent, mandala, anxiety, depression
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ActivityOther
Mandala is a method of expressing one's feelings and thoughts. The person draws and paints the paper in a round shape.
Routine nursing careOther
Interventions routinely implemented by nurses in the clinic
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Mandala activity) | Experimental | Scales were applied to the experimental group in the first encounter with the adolescent (pre-test). Then, a total of two sessions of individual mandala activities were performed at least 48 hours apart. Each adolescent freely drawn and painted the unstructured mandala on white paper, starting from the center and expanding. The same scales were reapplied last (post-test). Receives: Other: Mandala Activity; Other: Routine nursing care |
| Control group | Other | Scales were applied to the control group with an interval of 5 days and received routine nursing care (pre-test, post-test). Receives: Other: Routine nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memorial Symptom Assessment Scale Psychological Sub Dimension
Memorial Symptom Assessment Scale is a scale developed by Portenoy et al. In 1994 in order to determine the symptoms experienced by patients with cancer diagnosis in the last week. In 2000, Collins et al. Adapted the scale to adults by carrying out the validity and reliability study of children aged 10-18 years of age. Adaptation, validity and reliability studies were carried out in 2007 by Atay et al. The psychological sub-dimension of the scale was used in the planned study. In this study, Cronbach's alpha value of all items of the scale was determined as .90. The statistically significant increase in the mean score of psychological symptoms in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.
Measured: 5 day
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale was developed in 1983 by Zigmond and Snaith. The Turkish version of the scale in the adult age group was made in 1997 by Aydemir et al. The application time of the scale is 2-5 minutes. In 2014, Erkan adapted to Turkish culture and language in the 12-17 adolescent age group, and its validity and reliability study was performed. The scale consists of 14 items, it includes the 7-item Anxiety subscale and Depression subscale. In each item, a score of 0-3 is obtained by choosing one of the four-likert type options.
The statistically significant increase in the mean score of anxiety and depression in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start15 Mar 2019
- Primary completion15 Apr 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Gürcan, Akdeniz University
- Investigators
- Sevcan ATAY TURAN, PhD, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297982
- Sponsor's protocol ID
- AkUn
- Status last verified
- Jan 2021
- First submitted
- 4 Mar 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malchiodi, C. A. Medical art therapy with children: Jessica Kingsley Publishers; 1999,
Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
PubMed 7999421Kim, S.-i., Ghil, J.-H., Choi, E.-Y., Kwon, O.-S., & Kong, M. A computer system using a structured mandala to differentiate and identify psychological disorders. The Arts in Psychotherapy. 2014; 41 (2): 181-186.
Kostyunina, N. Y., & Drozdikova-Zaripova, A. R. Adolescents' school anxiety correction by means of mandala art therapy. International Journal of Environmental and Science Education. 2016; 11 (6): 1105-1116.
Wagner, H. The use of music and mandala to explore the client/therapist relationship in a therapeutic day school. Qualitative Inquiries in Music Therapy. 2012; 7.
Stinley, N. E., Norris, D. O., & Hinds, P. S. Creating mandalas for the management of acute pain symptoms in pediatric patients. Art Therapy. 2015; 32 (2): 46-53.
Serokowa D, Kreska B. [Rabies]. Przegl Epidemiol. 1975;29(1):117-20. No abstract available. Polish.
PubMed 1118635Gurcan M, Atay Turan S. The effectiveness of mandala drawing in reducing psychological symptoms, anxiety and depression in hospitalised adolescents with cancer: A randomised controlled trial. Eur J Cancer Care (Engl). 2021 Nov;30(6):e13491. doi: 10.1111/ecc.13491. Epub 2021 Jul 29.
PubMed 34322921
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Activity on Psychological Symptoms, Anxiety and Depression Level of Adolescents Receiving Cancer Treatment
- ClinicalTrials.gov ID
- NCT04297982
- Acronym / sponsor ID
- AkUn
- Conditions
- Nursing
- Keywords
- cancer, adolescent, mandala, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 6 Mar 2020 (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.
Aim: The aim of this study is to determine the effect of mandala activity on adolescents receiving cancer treatment on psychological symptoms and anxiety/depression level.
Method: The study was conducted as a randomized controlled experimental study with adolescents aged 12-17 years receiving cancer treatment in Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample group was composed of 30 adolescents in the experimental group and 30 adolescents in the control group using the closed envelope system in accordance with the selection criteria of the sample. The experimental group was given 2 sessions of mandala drawing and staining activity with music at least 48 hours apart. In the study, individual activity was preferred. In each session, adolescents were allowed to draw and stain a mandala. 'Data Collection Form' before the first session, 'Memorial Symptom Assessment Scale', ''Hospital Anxiety and Depression Scale were applied to the experimental group before and after the first session. The same data collection tools were applied to the control group at 48 hours intervals without any activity.
Detailed description
Type of the Study This research; This is a randomized controlled experimental study to determine whether mandala activity applied to adolescents receiving cancer treatment has an effect on psychological symptoms and anxiety / depression level.
Place and Time of the Study The research was carried out in Antalya Akdeniz University Hospital, Child Hematology / Oncology Clinic. The research data were collected by the researcher between March 2019 and February 2020. Akdeniz University Child Hematology and Oncology Clinic is a 32-bed institution where children between 0-18 years old receive inpatient treatment and care. It is forbidden to visit the clinic to protect patients from infection, thereby providing a calm environment in the clinic. The rooms are double and single.
Mandala activity at a normal room temperature (average 25 ° C), in terms of being bright enough and a comfortable environment for adolescents; It was planned to have a room that was spacious, clean, with a window opening (not opening to the corridor) and in sunlight, and it was decided that the most suitable environment in the clinic was the patient's own room.
Sample of the Research The sampling of the study was composed of all adolescents who received cancer treatment in Akdeniz University Hospital Child Hematology / Oncology Clinic. Adolescents who accepted to participate in the study on a voluntary basis and having the inclusion criteria constituted the sample of the study. The sample group was formed in accordance with the sample selection criteria and divided into two as experimental and control groups. As a result of the power analysis, the sample group with 80% power and 0.05 error margin; The experimental group 30 and the control group 30 were planned to form a total of 60 children receiving cancer treatment.
Data Collection Tools In this study; Two scales were used for the descriptive features of the Personal Information Form, Memorial Symptom Evaluation Scale Psychological Sub-Dimension (MSDÖ-P) and Hospital Anxiety and Depression Scale (Adolescent Age Group Form).
Prior to the research, permission was obtained from the Antalya Akdeniz University Clinical Research Ethics Committee regarding the method and design of the study (Decision No: 492, Date: 11.07.2018). After obtaining the approval of the ethics committee, necessary verbal and written permissions were obtained from Akdeniz University Hospital. Permission was obtained to use the Memorial Symptom Assessment Scale, which was adapted to Turkish for children aged 10-18 by Atay in 2008, validity and reliability study. Permission was obtained via e-mail to use the Hospital Anxiety and Depression Scale, which was validated for validity and reliability in the adolescent age group by Erkan in 2014.
Before starting the study, it was explained to the adolescent about the purpose, duration, fee of the research, all information will be kept confidential and will not be used anywhere other than the thesis. In addition, informed consent was obtained from the adolescent by explaining that there will be no difficulty in participating in the study and that the study is based on volunteering, and that they can leave whenever they want during the application phase. Before the application of the research, the parent was informed about the research in written or verbally. The researcher attended mandala education before the thesis study.
Mandala Activity (İnterventation Group) Scales were applied to the experimental group in the first encounter with the adolescent (pre-test). One day later, one session of individual mandala activity were performed. Later at least 48 hours, also one session of individual mandala activity. Each adolescent created two seans mandala and freely drawn and painted the unstructured mandala on white paper, starting from the center and expanding. A day after the second session mandala activity the same scales were reapplied last (post-test).
Control Group Scales were applied to the control group with an interval of 5 days and received routine nursing care (pre-test, post-test).
Mandala Activity Application Steps
- Researchers ensured that the patient is not in times such as sleep or meal time.
- The best time for the activity was determined by exchanging ideas with the patient.
- Hygienic rules were taken care of (Washing hands and wiping the materials with alcohol cotton).
- A comfortable environment has been provided for activities (the room is bright enough, closing the room door to prevent noise, lifting the back of the bed with the patient in a sitting position, and adjusting the height of the table brought in front of the patient).
- Sample videos on how to draw mandala were watched before the application.
- Adolescents were told that the beauty of the drawings was not important, as the mandala is a means of expression and sharing.
- In the individual mandala activity, the drawings were made with classical / instrumental music.
- It was provided to paint and then paint before painting from the center on the picture paper without disturbing the order.
- When created mandala, all the drawings and paintings were made inside the circles drawn together.
- Adolescents are free to choose colors and shapes during the individual mandala activity.
- Unless the adolescents asked for help, the researcher did not intervene in the mandala drawing
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Mandala activity) | Experimental | Other: Mandala Activity, Other: Routine nursing careScales were applied to the experimental group in the first encounter with the adolescent (pre-test). Then, a total of two sessions of individual mandala activities were performed at least 48 hours apart. Each adolescent freely drawn and painted the unstructured mandala on white paper, starting from the center and expanding. The same scales were reapplied last (post-test). |
| Control group | Other | Other: Routine nursing careScales were applied to the control group with an interval of 5 days and received routine nursing care (pre-test, post-test). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Must be able to read and speak Turkish
- Clinical diagnosis of cancer disease
- The ages of 12-17.
- The duration of diagnosis is at least 2 months
- Must be have cancer treatment,
Key exclusion criteria (1 listed)
- The patient is in the terminal period
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 ActivityMandala is a method of expressing one's feelings and thoughts. The person draws and paints the paper in a round shape. | Other | Intervention group (Mandala activity) |
| Routine nursing careInterventions routinely implemented by nurses in the clinic | Other | Control group, Intervention group (Mandala activity) |
Primary outcome
Memorial Symptom Assessment Scale Psychological Sub Dimension
Time frame: 5 day
Memorial Symptom Assessment Scale is a scale developed by Portenoy et al. In 1994 in order to determine the symptoms experienced by patients with cancer diagnosis in the last week. In 2000, Collins et al. Adapted the scale to adults by carrying out the validity and reliability study of children aged 10-18 years of age. Adaptation, validity and reliability studies were carried out in 2007 by Atay et al. The psychological sub-dimension of the scale was used in the planned study. In this study, Cronbach's alpha value of all items of the scale was determined as .90. The statistically significant increase in the mean score of psychological symptoms in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.
Hospital Anxiety and Depression Scale
Time frame: 5 day
Hospital Anxiety and Depression Scale was developed in 1983 by Zigmond and Snaith. The Turkish version of the scale in the adult age group was made in 1997 by Aydemir et al. The application time of the scale is 2-5 minutes. In 2014, Erkan adapted to Turkish culture and language in the 12-17 adolescent age group, and its validity and reliability study was performed. The scale consists of 14 items, it includes the 7-item Anxiety subscale and Depression subscale. In each item, a score of 0-3 is obtained by choosing one of the four-likert type options. The statistically significant increase in the mean score of anxiety and depression in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.
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 26 Jan 2021.
- BackgroundMalchiodi, C. A. Medical art therapy with children: Jessica Kingsley Publishers; 1999,
- Background: PubMed 7999421Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.
- BackgroundKim, S.-i., Ghil, J.-H., Choi, E.-Y., Kwon, O.-S., & Kong, M. A computer system using a structured mandala to differentiate and identify psychological disorders. The Arts in Psychotherapy. 2014; 41 (2): 181-186.
- BackgroundKostyunina, N. Y., & Drozdikova-Zaripova, A. R. Adolescents' school anxiety correction by means of mandala art therapy. International Journal of Environmental and Science Education. 2016; 11 (6): 1105-1116.
- BackgroundWagner, H. The use of music and mandala to explore the client/therapist relationship in a therapeutic day school. Qualitative Inquiries in Music Therapy. 2012; 7.
- BackgroundStinley, N. E., Norris, D. O., & Hinds, P. S. Creating mandalas for the management of acute pain symptoms in pediatric patients. Art Therapy. 2015; 32 (2): 46-53.
- Background: PubMed 1118635Serokowa D, Kreska B. [Rabies]. Przegl Epidemiol. 1975;29(1):117-20. No abstract available. Polish.
- Derived from this study: PubMed 34322921Gurcan M, Atay Turan S. The effectiveness of mandala drawing in reducing psychological symptoms, anxiety and depression in hospitalised adolescents with cancer: A randomised controlled trial. Eur J Cancer Care (Engl). 2021 Nov;30(6):e13491. doi: 10.1111/ecc.13491. Epub 2021 Jul 29.
- 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.
Sevcan ATAY TURAN, PhD study director
Akdeniz University
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 Activity and Routine nursing care in people with Nursing, run by Akdeniz 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 1 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 26 Jan 2021. 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?
Memorial Symptom Assessment Scale Psychological Sub Dimension (time frame: 5 day). 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?
On the ClinicalTrials.gov record for NCT04297982, which also lists 8 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 26 Jan 2021.