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NCT Number: NCT07561918

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

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.

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Key information

Conditions

End Stage Renal Disease / Hemodialysis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Hospital, OMC Dialysis Center

Lahore, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandala Coloring

Behavioral

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.

Free-Form Drawing

Behavioral

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 outcomes

  1. 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).

  2. 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).

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebadat Noor Malik

CONTACT

[email protected]

+923367277899

Sara Asad

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kinnaird College for Women

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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