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

Sponsor
Istanbul Sabahattin Zaim University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05296018
Collaborator
(none)
60
2
2
3.8
30
7.8

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Mandala coloring page
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is an experimental study with pre-test and post-test control groupsThis study is an experimental study with pre-test and post-test control groups
Masking:
Single (Participant)
Masking Description:
Single (Participant) Mandala and control group
Primary Purpose:
Supportive Care
Official Title:
The Effect of Mandala on Coping With Fatigue, Psychological Well-Being and Stress in Patients Treated With Hemodialysis
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mandala

Mandala coloring page

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

No Intervention: Control group

Routine maintenance will be applied

Outcome Measures

Primary Outcome Measures

  1. The fatigue severity scale [1. week]

    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.

  2. The fatigue severity scale [4. week]

    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.

  3. The fatigue severity scale [8. week]

    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. The psychological well-being scale [1. week]

    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.

  5. The psychological well-being scale [4. week]

    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.

  6. The psychological well-being scale [8. week]

    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.

  7. The Ways of Coping Inventory (WCI) [1. week]

    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. The Ways of Coping Inventory (WCI) [4. week]

    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.

  9. The Ways of Coping Inventory (WCI) [8. week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Sabahattin Zaim University, Faculty of Health Sciences Istanbul Güneydoğu Anadolu Bölgesi Turkey 340340
2 Istanbul Sabahattin Zaim University, Faculty of Health Sciences Istanbul Küçükçekmece Turkey 34303

Sponsors and Collaborators

  • Istanbul Sabahattin Zaim University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zülfünaz ÖZER, Principal Investigator, Istanbul Sabahattin Zaim University
ClinicalTrials.gov Identifier:
NCT05296018
Other Study ID Numbers:
  • 2022-01
First Posted:
Mar 25, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zülfünaz ÖZER, Principal Investigator, Istanbul Sabahattin Zaim University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022