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

NCT07561918 | Not Yet Recruiting

• 1 other identifier: MCI-HD-PSY-MS-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease / Hemodialysis

Keywords

Mandala Coloring; Hemodialysis; State Mindfulness; Mood; Psychological Distress; Art Therapy; Quasi experimental

Outcome Measures

Primary Outcomes (3)

• State Mindfulness

  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

  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

  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

Study Arms (2)

Mandala Coloring

EXPERIMENTAL

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

Free-Form Drawing

ACTIVE COMPARATOR

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

Interventions

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.

Mandala Coloring

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.

Free-Form Drawing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18-50 years, receiving in-center hemodialysis 2-3 times per week, will be included. Patients with scores ranging from 20-29 on Kessler Psychological Distress Scale (K10), will be included. Patients who can read and comprehend English or Urdu were included.

You may not qualify if:

• Patients with an arteriovenous fistula in their dominant arm will be excluded. Patients with dementia, delirium, or hearing difficulties - conditions that would prevent them from understanding and responding to the questionnaire or participating in the intervention - will be excluded. Patients undergoing hemodialysis due to acute renal failure and ongoing chemotherapy or radiotherapy will be excluded.

Sponsors & Collaborators

• Kinnaird College for Women: lead

Study Sites (1)

Sheikh Zayed Hospital, OMC Dialysis Center

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebadat Noor Malik

  Kinnaird College for Women

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ebadat Noor Malik

CONTACT

+923367277899; ebadattnoor@gmail.com

Sara Asad

CONTACT

sara.asad@kinnaird.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Quasi-experimental pretest-posttest non-equivalent control group research design

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)