Effectiveness of Mandala Coloring on State Mindfulness, Mood and Psychological Distress Among Patients Undergoing Hemodialysis

May 7, 2026 updated by: Ebadat Noor Malik, Kinnaird College for Women

The goal of this study is to see if mandala coloring helps improve state mindfulness, mood and psychological distress in patients undergoing hemodialysis. The study will also compare mandala coloring with free-form coloring.

The main questions are:

Does mandala coloring improve state mindfulness in hemodialysis patients compared to free-form coloring? Does mandala coloring improve mood compared to free-form coloring? Does mandala coloring reduce psychological distress compared to free-form coloring?

Participants will be placed into two groups. One group will do mandala coloring and the other group will do free-form coloring. Both groups will complete assessment before and after the activity.

Researchers will compare results from before and after the activity and also between the two groups, to see if there are any differences.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Sheikh Zayed Hospital, OMC Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-50 years
  • Receiving in-center hemodialysis 2-3 times per week
  • Scored in the range 20-29 on Kessler Psychological Distress Scale (K10)
  • Able to read and understand English or Urdu

Exclusion Criteria:

  • Arteriovenous fistula in the dominant arm
  • Diagnosis of dementia or delirium
  • Presence of hearing impairment, interfering with participation
  • Acute renal failure
  • Current chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mandala Coloring
Participants in the experimental group will be provided with printed mandala designs on A4 sheets. The same mandala design will be used for all participants. A set of colored pencils will be provided. Participants will complete a single mandala coloring session. Psychological outcomes will be assessed at baseline and immediately after the intervention.
Behavioral: Mandala Coloring
This intervention involves a single-session structured mandala coloring activity using standardized printed mandala designs on A4 sheets. All participants receive the same design to ensure consistency and reduce variation across individuals. The intervention is designed as a brief, low-cost, non-pharmacological behavioral technique aimed at inducing relaxation and enhancing state mindfulness in patients undergoing hemodialysis.
Active Comparator: Free-Form Drawing
Participants in the control group will be provided with plain white A4 sheets and colored pencils and will engage in free-form drawing. Psychological outcomes will be assessed at baseline and immediately after the session.
Behavioral: Free-Form Drawing
This comparator intervention will involve a single-session free-form drawing activity using plain white A4 sheets and colored pencils. Participants were instructed to draw freely without predefined patterns or structured designs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Mindfulness
Time Frame: Baseline and immediately after the intervention
State mindfulness will be assessed using the State Mindfulness Scale (SMS), a self-report questionnaire, rated on a 5-point Likert scale (1 = not at all to 5 = extremely).
Baseline and immediately after the intervention
Mood
Time Frame: Baseline and immediately after the intervention
Mood will be assessed using the Positive and Negative Affect Schedule (PANAS), a 20-item self-report scale rated on 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely).
Baseline and immediately after the intervention
Psychological Distress
Time Frame: Baseline and immediately after the intervention
Psychological distress will be assessed using the Depression Anxiety Stress Scale (DASS-21), a 21-item scale rated on a 0-3 Likert scale where 0 = did not apply to me at all and 3 = applied to me most of the time.
Baseline and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinnaird College for Women

Investigators

  • Principal Investigator: Ebadat Noor Malik, Kinnaird College for Women

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCI-HD-PSY-MS-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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