CClinicalTrials.gg
Status unknownNCT05344820ARQULAUpdated Jun 22, 2022

The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy

An interventional study of Art based mandala in Cancer, Chemotherapy Effect and Fatigue, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.

Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Read the detailed description

A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature.

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

02

Conditions studied

  • Cancer
  • Chemotherapy Effect
  • Fatigue
  • Quality of Life
  • Rumination
  • Alexithymia

Keywords

  • cancer
  • Chemotherapy Effect
  • Fatigue
  • Quality of Life
  • Rumination
  • Alexithymia
03

In context

Rumination Syndrome

72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.

This study's planned enrollment of 90 is above the median of 62 across 63 interventional studies indexed under Rumination Syndrome.

Browse Rumination Syndrome studies →

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 years or older
  • Conscious and no communication problems
  • Being literate
  • Having a cancer diagnosis
  • Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks)
  • Willing to participate in our study voluntarily

Exclusion criteria

Exclusion Criteria:

  • Not being willing to participate in the research
  • Desire to leave the study at any time
  • Deterioration of compliance with the working criteria during the time of the study,
  • Those who do not participate in up to four mandala applications during the study period
  • Those who cannot use a pen
  • Those with a diagnosis of psychiatric and neurological disease
  • Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Mandala Intervention

    To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.

    Behavioral: Art based mandala

  • No intervention
    Control

    No intervention will be applied to the control group

Interventions

  • BehavioralArt based mandala

    To the experimental group; Mandala practice will be done for 2 hours, once a week for 8 weeks.

06

What researchers measure

Primary outcomes

  1. level of quality of life

    Level of quality of life as assessed by the Quality of Life Scale for the Treatment and Research of Cancer (min:0, max:100,with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales)

    Time frame: 1 week

  2. level of fatigue

    level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)

    Time frame: 1 week

Secondary outcomes

  1. level of alexithymia

    level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic)

    Time frame: 1 week

  2. level of rumination

    level of rumination assessed by ruminative thought scale (higher values means more ruminative thought)

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Sultan Abdülhamid Training and Research Hospital
    Üsküdar, İstanbul 34660, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05344820
Lead sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible party
Elif Yıldırım Ayaz (Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey) — Principal investigator
First posted
Apr 25, 2022
Start date
May 19, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jun 22, 2022

Study contacts

Elif Yıldırım Ayaz, M.D.
Contact
drelifyildirim@hotmail.com
+905325148300
Elif Yıldırım Ayaz, M.D.
principal investigator · Sultan Abdülhamid Training And Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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