NCT07004088

Brief Summary

In kidney patients, especially the continuous dialysis treatment can cause symptoms which adversely affect patients' self-care abilities and quality of life. T Nonpharmacological methods can be used to reduce low and moderate symptoms. Mandala is one of the non-pharmacological approaches and is used in many areas with its therapeutic properties. In the literature review on the effect of mandala application on dialysis patients symptoms and self care, no research was found. The aim of this study was to determine the effect of mandala coloring on dialysis symptoms and self-care of female patients receiving hemodialysis treatment. Data were collected by using personal information form, Dialysis Symptom Index Scale, Self-Care Power Scale for Chronic Dialysis Patients. As an intervention tool, a circular mandala and 12 felt paint were used in the study. Study was designed as a randomized control study Intervention Group; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken. Control Group; Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. After the sixth dialysis session, the women were asked to refill the scales.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 17, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

dialysissymptom indexself care

Outcome Measures

Primary Outcomes (2)

  • dialysis related symptom

    Dialysis Symptom Index (DSI); The Dialysis Symptom Index (DSI) was developed by Weisbord et al. (2005) to determine the symptoms experienced by HD patients and the level of impact on patients. The Turkish reliability and validity of the scale was made by Önsöz and Yeşilbalkan (2013) and Cronbach's alpha value was reported as 0.84. DSI identifies 30 symptoms, either physical or emotional. In DSI, the symptoms experienced in the last week are answered as yes-no, and if the answer is yes, the extent to which the symptoms affected the patients who answered "yes" was evaluated as 0 = no, 1 = none, 2 = some, 3 = sometimes, 4 = very little, 5 = too much. The total scale score is obtained by adding the obtained scores. The score of the scale ranges from 0-150. The fact that the answers given to the scale increased towards 150 points indicates that the effect of the symptom in question increased. The internal consistency coefficient of the scale was determined as 0.84 (Usta, 2013).

    After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished

  • Self-Care Agency Scale for Patients on Long-Term Dialysis

    The scale was developed by Besey Ören in 2010 for HD and peritoneal dialysis patients. The Self-Care Agency Scale is an easily understandable, 22-item, 3-point Likert-type scale. The items are scored as follows: 0=I always apply, 1=I sometimes apply, and 2=I do not apply at all. It was created for people to express their status of applying selfcare habits in their daily lives. The patient is asked to choose the most appropriate option for him. The total score obtainable from the tool ranges between 0 and 44. Subscale scores are obtained by summing the item scores under each subscale. Accordingly, scores obtainable from the subscales are 0-12 for the use of medicine, 0-10 for diet, 0-8 for self-monitoring, 0-4 for hygienic care, and 0-6 for mental state. It shows that as the score obtained from the scale decreases, self-care ability decreases.16 The α coefficient of the scale was 0.67.

    After voluntary consent is obtained, the scale filled in by interviewing the patients one-on-one before the mandala painting attempt begins. 4 weeks after the completion of the mandala colouring the scale replenished

Study Arms (2)

Mandala group

EXPERIMENTAL

Female patients undergoing dialysis treatment in the dialysis unit were given mandalas for 20-30 minutes and asked to paint during 6 dialysis session, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled before and after the sixth dialysis session, t

Behavioral: Mandala coloring

Control Group

NO INTERVENTION

Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. Volunteer consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled at the beginning and after the sixth dialysis session

Interventions

Female patients undergoing dialysis treatment in the dialysis unit were informed about the study. After women are informed about the effects of mandala application on health and how to paint mandala; voluntary consent form, personal information form, "Dialysis Symptom Index Scale", "Self-Care Power Scale for Chronic Dialysis Patients" were filled. One hour after the start of each dialysis session, the patients were given mandalas for 20-30 minutes and asked to paint. The women's own paints and mandalas were preserved for the next session. After the sixth dialysis session , the patients were asked to refill the scales with one-on-one interviews, and the verbal opinions and feedback of the patients about the application were taken.

Mandala group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 18 years or older
  • Able to communicate adequately
  • No psychiatric problems
  • No vision problems
  • Receiving hemodialysis treatment for at least 6 months
  • Willing and able to provide informed consent to participate in the study

You may not qualify if:

  • Hemodialysis patients younger than 18 years of age
  • Patients with physical or psychological limitations that interfere with -participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialysis Center

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2025

First Posted

June 4, 2025

Study Start

September 10, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations