End Stage Renal Disease / HemodialysisNCT07561918
Effectiveness of Mandala Coloring on State Mindfulness, Mood and Psychological Distress Among Patients Undergoing Hemodialysis
A study testing Mandala Coloring and Free-Form Drawing in people with End Stage Renal Disease / Hemodialysis, run by Kinnaird College for Women at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- End Stage Renal Disease / Hemodialysis
- What is being tested?
- Mandala Coloring and Free-Form Drawing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Asad contact
Pakistan1 site
Sheikh Zayed Hospital, OMC Dialysis Center
Lahore, Punjab Province
About this study
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:
Read more
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
- Being tested
- Mandala Coloring, Free-Form Drawing
- Keywords
- Mandala Coloring, Hemodialysis, State Mindfulness, Mood, Psychological Distress, Art Therapy, Quasi experimental
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ColoringBehavioural
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 DrawingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Free-Form Drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease / HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental pretest-posttest non-equivalent control group research design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kinnaird College for Women
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebadat Noor Malik, Kinnaird College for Women
- Investigators
- Ebadat Noor Malik, Principal investigator, Kinnaird College for Women
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561918
- Sponsor's protocol ID
- MCI-HD-PSY-MS-2026
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mandala Coloring on State Mindfulness, Mood and Psychological Distress Among Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07561918
- Acronym / sponsor ID
- MCI-HD-PSY-MS-2026
- Conditions
- End Stage Renal Disease / Hemodialysis
- Keywords
- Mandala Coloring, Hemodialysis, State Mindfulness, Mood, Psychological Distress, Art Therapy, Quasi experimental
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kinnaird College for WomenUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental pretest-posttest non-equivalent control group research design
| Arm | Type | Receives |
|---|---|---|
| Mandala Coloring | Experimental | Behavioral: Mandala ColoringParticipants 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. |
| Free-Form Drawing | Active comparator | Behavioral: Free-Form DrawingParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandala ColoringThis 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. | Behavioural | Mandala Coloring |
| Free-Form DrawingThis 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. | Behavioural | Free-Form Drawing |
Primary outcome
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).
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Asad contact
Ebadat Noor Malik principal investigator
Kinnaird College for Women
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Coloring and Free-Form Drawing in people with End Stage Renal Disease / Hemodialysis, run by Kinnaird College for Women at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebadat Noor Malik (+923367277899, ebadattnoor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Mindfulness (time frame: Baseline and immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.