- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ebadat Noor Malik
- Telefonnummer: +923367277899
- E-post: ebadattnoor@gmail.com
Studera Kontakt Backup
- Namn: Sara Asad
- E-post: sara.asad@kinnaird.edu.pk
Studieorter
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- Sheikh Zayed Hospital, OMC Dialysis Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
State Mindfulness
Tidsram: 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).
|
Baseline and immediately after the intervention
|
|
Mood
Tidsram: 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).
|
Baseline and immediately after the intervention
|
|
Psychological Distress
Tidsram: 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.
|
Baseline and immediately after the intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ebadat Noor Malik, Kinnaird College for Women
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Njurinsufficiens, kronisk
- Patologiska tillstånd, tecken och symtom
- Njursvikt, kronisk
Andra studie-ID-nummer
- MCI-HD-PSY-MS-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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