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

NCT05296018 | Completed

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Hemodialysis

Keywords

Fatigue; Psychological Well-Being; Stress

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Mandala

EXPERIMENTAL

Mandala coloring page

Other: Mandala coloring page

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

Mandala coloring page OTHER

Mandala program will be applied three days a week (30 minutes) for 8 weeks.

Mandala

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 6 months

You may not qualify if:

• None

Sponsors & Collaborators

• Istanbul Sabahattin Zaim University: lead

Study Sites (2)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Güneydoğu Anadolu Bölgesi, 340340, Turkey (Türkiye)

Location

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Küçükçekmece, 34303, 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 RESULT

MeSH Terms

Conditions

Fatigue; Psychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

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

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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: April 4, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)