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Not yet recruiting NCT07561918

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

No phase Interventional End Stage Renal Disease / Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mandala Coloring, Free-Form Drawing.
Who it may be relevant to
Registry conditions: End Stage Renal Disease / Hemodialysis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • State Mindfulness [Time frame: Baseline and immediately after the intervention]
  • Mood [Time frame: Baseline and immediately after the intervention]
  • Psychological Distress [Time frame: Baseline and immediately after the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Sheikh Zayed Hospital, OMC Dialysis Center — Lahore

Identifiers

NCT: NCT07561918 · MCI-HD-PSY-MS-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗