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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296018
• Other study ID #: 2022-01
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Istanbul Sabahattin Zaim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

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 6 months

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Fatigue
• Hemodialysis

Intervention

Other:
• Mandala coloring page
Mandala program will be applied three days a week (30 minutes) for 8 weeks.

Locations

Country	Name	City	State
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul	Güneydogu Anadolu Bölgesi
Turkey	Istanbul Sabahattin Zaim University, Faculty of Health Sciences	Istanbul	Küçükçekmece

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). pii: 642. doi: 10.3390/healthcare90606 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1. week
Primary	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.	4. week
Primary	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.	8. week
Primary	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.	1. week
Primary	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.	4. week
Primary	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.	8. week
Primary	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.	1. week
Primary	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.	4. week
Primary	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.	8. week