- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ebadat Noor Malik
- Telefonnummer: +923367277899
- E-post: ebadattnoor@gmail.com
Studer Kontakt Backup
- Navn: Sara Asad
- E-post: sara.asad@kinnaird.edu.pk
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Sheikh Zayed Hospital, OMC Dialysis Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
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Aktiv komparator: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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State Mindfulness
Tidsramme: 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).
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Baseline and immediately after the intervention
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Mood
Tidsramme: 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).
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Baseline and immediately after the intervention
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Psychological Distress
Tidsramme: Baseline and immediately after the intervention
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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.
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Baseline and immediately after the intervention
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ebadat Noor Malik, Kinnaird College for Women
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Nyresvikt, kronisk
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
Andre studie-ID-numre
- MCI-HD-PSY-MS-2026
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