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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05907070
Other study ID # 2023.9
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date July 2024

Study information

Verified date December 2023
Source Akdeniz University
Contact Meltem GÜRCAN, Res. Assist.
Phone 05065086214
Email meltemgurcan32@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The population of the study consists of the parents of children diagnosed with cancer in the Akdeniz University Hospital Pediatric Hematology and Oncology Clinic. The sample of the study is three groups; intervention 1 group (n:25), intervention 2 group (n:25) and control group (n:25) will consist of a total of 75 people. A closed envelope system with simple randomization will be used in sample selection. Intervention 1 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. Intervention 2 groups will participate in the value clarification activity by writing 2 sessions individually with the theme of 'Emotions' accompanied by classical or instrumental music. The Personal Information Form, State Anxiety Inventory and Positive-Negative Affect Scale will be applied to the intervention groups at the first session and the second session to collect pre-test and post-test data. No intervention will be made to the control group, and the same data collection tools will be applied to the intervention groups. İn addition, in this study, a qualitative study will be conducted to determine the experiences of parents of children with cancer. For the qualitative study, the participant will be asked to interpret the colors and shapes of the mandala parent drew in the second session, and a face-to-face interview will be held with a semi-structured form.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mandala group
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.
Value clarification 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.

Locations

Country Name City State
Turkey Meltem Gürcan Antalya

Sponsors (2)

Lead Sponsor Collaborator
Akdeniz University Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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. 5 days after pre-test
Primary 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
Primary 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. 5 days after pre-test
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