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The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis

Primary Purpose

Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mandala coloring page
Sponsored by
Istanbul Sabahattin Zaim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodialysis focused on measuring Fatigue, Psychological Well-Being, Stress

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 6 months

Exclusion Criteria:

  • None

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mandala

Control group

Arm Description

Mandala coloring page

Routine maintenance will be applied

Outcomes

Primary Outcome Measures

The fatigue severity scale
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
The fatigue severity scale
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
The fatigue severity scale
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
The psychological well-being scale
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
The psychological well-being scale
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
The psychological well-being scale
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
The Ways of Coping Inventory (WCI)
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.
The Ways of Coping Inventory (WCI)
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.
The Ways of Coping Inventory (WCI)
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2022
Last Updated
November 23, 2022
Sponsor
Istanbul Sabahattin Zaim University
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1. Study Identification

Unique Protocol Identification Number
NCT05296018
Brief Title
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Official Title
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to examine the effect of mandala on coping with fatigue, psychological well-being and stress in patients treated with hemodialysis
Detailed Description
The Effect of Mandala on Coping with Fatigue, Psychological Well-Being and Stress in Patients Treated with Hemodialysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis
Keywords
Fatigue, Psychological Well-Being, Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pre-test and post-test control groups
Masking
Participant
Masking Description
Single (Participant) Mandala and control group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mandala
Arm Type
Experimental
Arm Description
Mandala coloring page
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied
Intervention Type
Other
Intervention Name(s)
Mandala coloring page
Intervention Description
Mandala program will be applied three days a week (30 minutes) for 8 weeks.
Primary Outcome Measure Information:
Title
The fatigue severity scale
Description
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
Time Frame
1. week
Title
The fatigue severity scale
Description
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
Time Frame
4. week
Title
The fatigue severity scale
Description
The fatigue severity scale is a measurement of fatigue impact on functioning. It is a short, nine-item self-report questionnaire. Its application is very simple and quick.. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition. A total score of less than 36 suggests that you may not be suffering from fatigue. A total score of 36 or more suggests that you may need further evaluation by a physician.
Time Frame
8. week
Title
The psychological well-being scale
Description
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
Time Frame
1. week
Title
The psychological well-being scale
Description
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
Time Frame
4. week
Title
The psychological well-being scale
Description
The eight-item Psychological Well-Being Scale identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life.This is an 8-item selfreported, 7-point Likert-type measurement scale (1=strongly disagree to 7=strongly agree). Higher scores indicated a higher level of psychological well-being.
Time Frame
8. week
Title
The Ways of Coping Inventory (WCI)
Description
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.
Time Frame
1. week
Title
The Ways of Coping Inventory (WCI)
Description
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.
Time Frame
4. week
Title
The Ways of Coping Inventory (WCI)
Description
The Ways of Coping Inventory (WCI) was developed by Folkman and Lazarus (1980) in order to determine the ways by which individuals cope with general or specific stress situations. The scale is a 30-item likert type scale. The answers to the items of the scale are given in four stages, moving from "does not apply or not used" (0) to "used a great deal" Higher scores in "Self-confident", "Optimistic" and "Seeking of social support" (Approach based coping) mean better coping, and higher scores in "Submissive" and "Helpless styles" (Avoidance based coping) mean worse coping.
Time Frame
8. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 6 months Exclusion Criteria: None
Facility Information:
Facility Name
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
City
Istanbul
State/Province
Güneydoğu Anadolu Bölgesi
ZIP/Postal Code
340340
Country
Turkey
Facility Name
Istanbul Sabahattin Zaim University, Faculty of Health Sciences
City
Istanbul
State/Province
Küçükçekmece
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34071674
Citation
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.
Results Reference
result

Learn more about this trial

The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis

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