Mandala Colouring On Anxiety, Depression, Pain And Quality of Life (MANDALA)

October 28, 2023 updated by: Ayşe Nefise BAHÇECİK, Istanbul Sabahattin Zaim University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34034
        • Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Routine maintenance will be applied
Experimental: Mandala group
Mandala coloring page
Other: Mandala coloring
Mandala coloring page
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1. week
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
3. week
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.
1. week
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.
3. week
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
1. week
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
3. week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Sabahattin Zaim University

Investigators

  • Study Director: AYŞE NEFİSE BAHÇECİK, PhD, Istanbul Sabahattin Zaim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 24, 2022

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 28, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23.05.2022-2022/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study should not be disclosed before publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodialysis Patients

Clinical Trials on Mandala coloring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe