Mandala Colouring On Anxiety, Depression, Pain And Quality of Life

Hemodialysis Patients Clinical Trial

— MANDALA  

Official title:

The Effect Of Mandala Colouring On Anxiety, Depression, Pain And Quality of Life in Patients Receiving Haemodialysis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106763
• Other study ID #: 23.05.2022-2022/05
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: October 2023
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

The effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 24, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria: None

Related Conditions & MeSH terms

• Depression
• Hemodialysis Patients

Intervention

Other:
• Mandala coloring
Mandala coloring page

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Sabahattin Zaim University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1. week
Primary	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	3. week
Primary	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.	1. week
Primary	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.	3. week
Primary	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	1. week
Primary	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	3. week