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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05344820
Other study ID # ARQULA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 19, 2022
Est. completion date December 31, 2022

Study information

Verified date June 2022
Source Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Contact Elif Yildirim Ayaz, M.D.
Phone +905325148300
Email drelifyildirim@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: - 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Sultan Abdülhamid Training and Research Hospital Üsküdar Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 1 week
Primary level of fatigue level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue) 1 week
Secondary level of alexithymia level of alexithymia assessed by Toronto Alexythimia Scale (higher values means more alexithymic) 1 week
Secondary level of rumination level of rumination assessed by ruminative thought scale (higher values means more ruminative thought) 1 week
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