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

Cancer Clinical Trial

— ARQULA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05344820
• Other study ID #: ARQULA
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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