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

NCT06106763 | Completed

• 1 other identifier: 23.05.2022-2022/05
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis Patients

Keywords

Hemodialysis; Anxiety; Depression; Pain; Quality of Life; Mandala painting

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Mandala group

EXPERIMENTAL

Mandala coloring page

Other: Mandala coloring

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Mandala coloring OTHER

Mandala coloring page

Also known as: Control group

Mandala group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, 34034, Turkey (Türkiye)

Location

Related 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.

  PMID: 34071674 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• AYŞE NEFİSE BAHÇECİK, PhD

  Istanbul Sabahattin Zaim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Mandala and control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This study is an experimental study with pre-test and post-test control groups

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: September 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 24, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)