Hemodialysis PatientsMANDALANCT06106763
Mandala Colouring On Anxiety, Depression, Pain And Quality of Life
A study testing Mandala coloring in people with Hemodialysis Patients, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted as an experimental research to determine the effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- Mandala coloring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 24 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 Ability to communicate adequately Absence of psychiatric problems Volunteering to participate in the research Receiving hemodialysis treatment for at least 3 months
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
Istanbul, 34034
About this study
Official title: The Effect Of Mandala Colouring On Anxiety, Depression, Pain And Quality of Life in Patients Receiving Haemodialysis Treatment
The research was conducted as an experimental research to determine the effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.
Read the detailed description
The effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.
- Conditions
- Hemodialysis Patients
- Being tested
- Mandala coloring
- Keywords
- Hemodialysis, Anxiety, Depression, Pain, Quality of Life, Mandala painting
- Medical subject headings
- Anxiety Disorders, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala coloringOther
Also called Control group
Mandala coloring page
| Study group | Role | What they receive |
|---|---|---|
| Mandala group | Experimental | Mandala coloring page Receives: Other: Mandala coloring |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Measured: 1. week
Visual Analogue Scale (VAS)
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Measured: 3. week
Hospital Anxiety and Depression Scale (HAD)
The scale was designed to screen anxiety and depression mood states in the population with physical illness in a short time. The HAD scale consists of 2 subscales and 14 items scored between 0-3 as a 4-point Likert-type scale. The anxiety subscale includes items 1, 3, 5, 7, 9, 11 and 13 and is scored between 0-21, the depression subscale includes items 2, 4, 6, 8, 10, 12 and 14 and is scored between 0-21. The scoring of items 1, 3, 5, 6, 8, 10, 11 and 13 is 3,2,1,0, while the scoring of items 2, 4, 7, 9, 12 and 14 is 0,1,2,3. A score above 7 in the depression subscale is compatible with depression, while a score above 10 in the anxiety subscale is compatible with anxiety.
Measured: 1. week
Hospital Anxiety and Depression Scale (HAD)
The scale was designed to screen anxiety and depression mood states in the population with physical illness in a short time. The HAD scale consists of 2 subscales and 14 items scored between 0-3 as a 4-point Likert-type scale. The anxiety subscale includes items 1, 3, 5, 7, 9, 11 and 13 and is scored between 0-21, the depression subscale includes items 2, 4, 6, 8, 10, 12 and 14 and is scored between 0-21. The scoring of items 1, 3, 5, 6, 8, 10, 11 and 13 is 3,2,1,0, while the scoring of items 2, 4, 7, 9, 12 and 14 is 0,1,2,3. A score above 7 in the depression subscale is compatible with depression, while a score above 10 in the anxiety subscale is compatible with anxiety.
Measured: 3. week
Kidney Disease Quality of Life Form (KDQOL-36)
The first part of the KDQOL-36 (items 1-12) includes the medical outcomes study short form 12 health survey (SF-12) as a generic core. It includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities. These 12 items make up the physical component summary (PCS) and mental component summary (MCS) scales. Some items contribute most to the PCS scale (items 1-5 and 8), whereas other items contribute most to the MCS scale (items 6, 7, and 9-12). The second part (items 13-16) constitutes burden of kidney disease subscale. It includes questions about how much kidney disease interferes with daily life, takes up time, causes frustration, or makes the respondent feel like a burden. The third part (items 17-28) covers symptoms and problem list subscale. It includes questions about how bothered a respondent feels by sore muscles, chest pain, cramps, itchy or dry skin, shortness of breath, faintness, lack o
Measured: 1. week
Kidney Disease Quality of Life Form (KDQOL-36)
The first part of the KDQOL-36 (items 1-12) includes the medical outcomes study short form 12 health survey (SF-12) as a generic core. It includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities. These 12 items make up the physical component summary (PCS) and mental component summary (MCS) scales. Some items contribute most to the PCS scale (items 1-5 and 8), whereas other items contribute most to the MCS scale (items 6, 7, and 9-12). The second part (items 13-16) constitutes burden of kidney disease subscale. It includes questions about how much kidney disease interferes with daily life, takes up time, causes frustration, or makes the respondent feel like a burden. The third part (items 17-28) covers symptoms and problem list subscale. It includes questions about how bothered a respondent feels by sore muscles, chest pain, cramps, itchy or dry skin, shortness of breath, faintness, lack o
Measured: 3. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Sep 2022
- Primary completion1 Sep 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis PatientsStudies 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
- This study is an experimental study with pre-test and post-test control groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nefise BAHÇECİK, Istanbul Sabahattin Zaim University
- Investigators
- AYŞE NEFİSE BAHÇECİK, PhD, Study director, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106763
- Sponsor's protocol ID
- 23.05.2022-2022/05
- Acronym
- MANDALA
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study should not be disclosed before publication
Publications
Choi H, Hahm SC, Jeon YH, Han JW, Kim SY, Woo JM. The Effects of Mindfulness-Based Mandala Coloring, Made in Nature, on Chronic Widespread Musculoskeletal Pain: Randomized Trial. Healthcare (Basel). 2021 May 28;9(6):642. doi: 10.3390/healthcare9060642.
PubMed 34071674
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Mandala Colouring On Anxiety, Depression, Pain And Quality of Life in Patients Receiving Haemodialysis Treatment
- ClinicalTrials.gov ID
- NCT06106763
- Acronym / sponsor ID
- MANDALA / 23.05.2022-2022/05
- Conditions
- Hemodialysis Patients
- Keywords
- Hemodialysis, Anxiety, Depression, Pain, Quality of Life, Mandala painting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 30 Oct 2023 (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.
The research was conducted as an experimental research to determine the effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.
Detailed description
The effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups
| Arm | Type | Receives |
|---|---|---|
| Mandala group | Experimental | Other: Mandala coloringMandala coloring page |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- be over 18 Ability to communicate adequately Absence of psychiatric problems Volunteering to participate in the research Receiving hemodialysis treatment for at least 3 months
Key exclusion criteria (1 listed)
- None
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 coloringAlso: Control groupMandala coloring page | Other | Mandala group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 1. week
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Visual Analogue Scale (VAS)
Time frame: 3. week
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Hospital Anxiety and Depression Scale (HAD)
Time frame: 1. week
The scale was designed to screen anxiety and depression mood states in the population with physical illness in a short time. The HAD scale consists of 2 subscales and 14 items scored between 0-3 as a 4-point Likert-type scale. The anxiety subscale includes items 1, 3, 5, 7, 9, 11 and 13 and is scored between 0-21, the depression subscale includes items 2, 4, 6, 8, 10, 12 and 14 and is scored between 0-21. The scoring of items 1, 3, 5, 6, 8, 10, 11 and 13 is 3,2,1,0, while the scoring of items 2, 4, 7, 9, 12 and 14 is 0,1,2,3. A score above 7 in the depression subscale is compatible with depression, while a score above 10 in the anxiety subscale is compatible with anxiety.
Hospital Anxiety and Depression Scale (HAD)
Time frame: 3. week
The scale was designed to screen anxiety and depression mood states in the population with physical illness in a short time. The HAD scale consists of 2 subscales and 14 items scored between 0-3 as a 4-point Likert-type scale. The anxiety subscale includes items 1, 3, 5, 7, 9, 11 and 13 and is scored between 0-21, the depression subscale includes items 2, 4, 6, 8, 10, 12 and 14 and is scored between 0-21. The scoring of items 1, 3, 5, 6, 8, 10, 11 and 13 is 3,2,1,0, while the scoring of items 2, 4, 7, 9, 12 and 14 is 0,1,2,3. A score above 7 in the depression subscale is compatible with depression, while a score above 10 in the anxiety subscale is compatible with anxiety.
Kidney Disease Quality of Life Form (KDQOL-36)
Time frame: 1. week
The first part of the KDQOL-36 (items 1-12) includes the medical outcomes study short form 12 health survey (SF-12) as a generic core. It includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities. These 12 items make up the physical component summary (PCS) and mental component summary (MCS) scales. Some items contribute most to the PCS scale (items 1-5 and 8), whereas other items contribute most to the MCS scale (items 6, 7, and 9-12). The second part (items 13-16) constitutes burden of kidney disease subscale. It includes questions about how much kidney disease interferes with daily life, takes up time, causes frustration, or makes the respondent feel like a burden. The third part (items 17-28) covers symptoms and problem list subscale. It includes questions about how bothered a respondent feels by sore muscles, chest pain, cramps, itchy or dry skin, shortness of breath, faintness, lack o
Kidney Disease Quality of Life Form (KDQOL-36)
Time frame: 3. week
The first part of the KDQOL-36 (items 1-12) includes the medical outcomes study short form 12 health survey (SF-12) as a generic core. It includes questions about general health, activity limits, ability to accomplish desired tasks, depression and anxiety, energy level, and social activities. These 12 items make up the physical component summary (PCS) and mental component summary (MCS) scales. Some items contribute most to the PCS scale (items 1-5 and 8), whereas other items contribute most to the MCS scale (items 6, 7, and 9-12). The second part (items 13-16) constitutes burden of kidney disease subscale. It includes questions about how much kidney disease interferes with daily life, takes up time, causes frustration, or makes the respondent feel like a burden. The third part (items 17-28) covers symptoms and problem list subscale. It includes questions about how bothered a respondent feels by sore muscles, chest pain, cramps, itchy or dry skin, shortness of breath, faintness, lack o
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 31 Oct 2023.
- Background: PubMed 34071674Choi H, Hahm SC, Jeon YH, Han JW, Kim SY, Woo JM. The Effects of Mindfulness-Based Mandala Coloring, Made in Nature, on Chronic Widespread Musculoskeletal Pain: Randomized Trial. Healthcare (Basel). 2021 May 28;9(6):642. doi: 10.3390/healthcare9060642.
- Individual participant dataSharing planned: No. The study should not be disclosed before publication
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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.
AYŞE NEFİSE BAHÇECİK, PhD study director
Istanbul Sabahattin Zaim 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 coloring in people with Hemodialysis Patients, run by Istanbul Sabahattin Zaim 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 1 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 31 Oct 2023. 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?
Visual Analogue Scale (VAS) (time frame: 1. week). The study lists 6 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 NCT06106763, which also lists 1 linked publication.
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 31 Oct 2023.