NCT05907070

Brief Summary

The research is planned to be conducted with a randomized controlled experimental study. In the research, it is aimed to determine the effect of mandala drawing art and value clarification application based on Watson Human Care Theory on the anxiety and mood of the parents of children with cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

June 8, 2023

Last Update Submit

July 8, 2024

Conditions

Keywords

childvalue clarificationparentcancermandalaart therapy

Outcome Measures

Primary Outcomes (4)

  • Positive-Negative Affect Scale (PANAS)

    The scale consists of 20 items, 10 of which are positive and 10 of which are negative, describing various emotions. The scale has 2 sub-dimensions: positive and negative affect.

    pre-test

  • Positive-Negative Affect Scale (PANAS)

    The scale consists of 20 items, 10 of which are positive and 10 of which are negative, describing various emotions. The scale has 2 sub-dimensions: positive and negative affect.

    2 or 3 days after pre-test

  • State Anxiety Inventory (STAI)

    The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 items. According to the level of life of individuals; It is answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely.

    pre-test

  • State Anxiety Inventory (STAI)

    The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 items. According to the level of life of individuals; It is answered by marking one of the options such as (1) not at all, (2) a little, (3) a lot, (4) completely.

    2 or 3 days after pre-test

Study Arms (3)

Mandala group

EXPERIMENTAL

Mandala drawing and coloring on paper

Other: Mandala group

Value clarification group

EXPERIMENTAL

Value clarification by writing on paper

Other: Value clarification group

Control group

NO INTERVENTION

Routine nursing care

Interventions

Mandala group will participate in 2 sessions of individual mandala drawing art activity with the theme of 'Emotions' accompanied by classical or instrumental music. In each session, a mandala will be created.

Mandala group

Value clarification groups will participate in the value clarification activity by writing 2 sessions individually with the theme of 'Emotions' accompanied by classical or instrumental music.

Value clarification group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having the ability to read, write, speak and understand Turkish
  • Being the parent of a 0-17-year-old child diagnosed with cancer
  • Staying in the hospital with child
  • Being hospitalized for at least the second course of treatment of the child

You may not qualify if:

  • Having a physical problem that may prevent you from drawing and typing a mandala and participating in value clarification
  • Not being able to take a break from caring for their child and participate in individual activities
  • Having the child in the terminal period
  • Relapse disease of the child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meltem Gürcan

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Sevcan ATAY TURAN, PhD

    Assistant Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

June 8, 2023

First Posted

June 18, 2023

Study Start

April 1, 2023

Primary Completion

May 15, 2024

Study Completion

June 15, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations