NCT04297982

Brief Summary

Aim: The aim of this study is to determine the effect of mandala activity on adolescents receiving cancer treatment on psychological symptoms and anxiety/depression level. Method: The study was conducted as a randomized controlled experimental study with adolescents aged 12-17 years receiving cancer treatment in Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample group was composed of 30 adolescents in the experimental group and 30 adolescents in the control group using the closed envelope system in accordance with the selection criteria of the sample. The experimental group was given 2 sessions of mandala drawing and staining activity with music at least 48 hours apart. In the study, individual activity was preferred. In each session, adolescents were allowed to draw and stain a mandala. 'Data Collection Form' before the first session, 'Memorial Symptom Assessment Scale', ''Hospital Anxiety and Depression Scale were applied to the experimental group before and after the first session. The same data collection tools were applied to the control group at 48 hours intervals without any activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

March 4, 2020

Last Update Submit

January 22, 2021

Conditions

Keywords

canceradolescentmandalaanxietydepression

Outcome Measures

Primary Outcomes (2)

  • Memorial Symptom Assessment Scale Psychological Sub Dimension

    Memorial Symptom Assessment Scale is a scale developed by Portenoy et al. In 1994 in order to determine the symptoms experienced by patients with cancer diagnosis in the last week. In 2000, Collins et al. Adapted the scale to adults by carrying out the validity and reliability study of children aged 10-18 years of age. Adaptation, validity and reliability studies were carried out in 2007 by Atay et al. The psychological sub-dimension of the scale was used in the planned study. In this study, Cronbach's alpha value of all items of the scale was determined as .90. The statistically significant increase in the mean score of psychological symptoms in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p\<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.

    5 day

  • Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale was developed in 1983 by Zigmond and Snaith. The Turkish version of the scale in the adult age group was made in 1997 by Aydemir et al. The application time of the scale is 2-5 minutes. In 2014, Erkan adapted to Turkish culture and language in the 12-17 adolescent age group, and its validity and reliability study was performed. The scale consists of 14 items, it includes the 7-item Anxiety subscale and Depression subscale. In each item, a score of 0-3 is obtained by choosing one of the four-likert type options. The statistically significant increase in the mean score of anxiety and depression in posttest measurement in the intervention group is the success criterion of the study. Significance level is set at p\<0.05 in analyzes. No statistically significant difference is expected in the pretest posttest mean scores of the control group.

    5 day

Study Arms (2)

Intervention group (Mandala activity)

EXPERIMENTAL

Scales were applied to the experimental group in the first encounter with the adolescent (pre-test). Then, a total of two sessions of individual mandala activities were performed at least 48 hours apart. Each adolescent freely drawn and painted the unstructured mandala on white paper, starting from the center and expanding. The same scales were reapplied last (post-test).

Other: Mandala ActivityOther: Routine nursing care

Control group

OTHER

Scales were applied to the control group with an interval of 5 days and received routine nursing care (pre-test, post-test).

Other: Routine nursing care

Interventions

Mandala is a method of expressing one's feelings and thoughts. The person draws and paints the paper in a round shape.

Intervention group (Mandala activity)

Interventions routinely implemented by nurses in the clinic

Control groupIntervention group (Mandala activity)

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must be able to read and speak Turkish
  • Clinical diagnosis of cancer disease
  • The ages of 12-17.
  • The duration of diagnosis is at least 2 months
  • Must be have cancer treatment,

You may not qualify if:

  • The patient is in the terminal period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meltem Gürcan

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (8)

  • Malchiodi, C. A. Medical art therapy with children: Jessica Kingsley Publishers; 1999,

    BACKGROUND
  • Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.

    PMID: 7999421BACKGROUND
  • Kim, S.-i., Ghil, J.-H., Choi, E.-Y., Kwon, O.-S., & Kong, M. A computer system using a structured mandala to differentiate and identify psychological disorders. The Arts in Psychotherapy. 2014; 41 (2): 181-186.

    BACKGROUND
  • Kostyunina, N. Y., & Drozdikova-Zaripova, A. R. Adolescents' school anxiety correction by means of mandala art therapy. International Journal of Environmental and Science Education. 2016; 11 (6): 1105-1116.

    BACKGROUND
  • Wagner, H. The use of music and mandala to explore the client/therapist relationship in a therapeutic day school. Qualitative Inquiries in Music Therapy. 2012; 7.

    BACKGROUND
  • Stinley, N. E., Norris, D. O., & Hinds, P. S. Creating mandalas for the management of acute pain symptoms in pediatric patients. Art Therapy. 2015; 32 (2): 46-53.

    BACKGROUND
  • Serokowa D, Kreska B. [Rabies]. Przegl Epidemiol. 1975;29(1):117-20. No abstract available. Polish.

    PMID: 1118635BACKGROUND
  • Gurcan M, Atay Turan S. The effectiveness of mandala drawing in reducing psychological symptoms, anxiety and depression in hospitalised adolescents with cancer: A randomised controlled trial. Eur J Cancer Care (Engl). 2021 Nov;30(6):e13491. doi: 10.1111/ecc.13491. Epub 2021 Jul 29.

MeSH Terms

Conditions

NeoplasmsAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Sevcan ATAY TURAN, PhD

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

March 15, 2019

Primary Completion

April 15, 2020

Study Completion

July 15, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations