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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05377918
Other study ID # B-TUGCEATAKMERIC-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date May 1, 2022

Study information

Verified date May 2022
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research will be carried out in two phases in order to verify the Turkish validity and reliability of the "Feeling Good, Living Life" (FGLL) Scale and to determine the effect of the diary kept using the spiritual writing technique on the anxiety and spiritual well-being level of the children aged 9-12 years who have been diagnosed with Type 1 Diabetes. The first phase of the research was carried out methodologically in Kartal Yavuz Selim Secondary School and Kartal Borsa Imam Hatip Secondary School in Kartal District of Istanbul Province between November-December 2021 for the Turkish validity and reliability study of the FGLL Scale. It has been determined that FGLL can be used as a valid and reliable tool for children aged 9-12 in Turkish society. In the second phase of the study, it was decided to conduct it at Kartal Dr. Lütfi Kırdar City Hospital in order to reach children between the ages of 9 and 12 who were diagnosed with Type 1 Diabetes, and necessary permissions were obtained from the institutions. Istanbul/Kartal Dr. Sample calculations were made with the G*Power 3.1 program in children diagnosed with Type 1 Diabetes, who applied to the Lütfi Kırdar City Hospital Pediatric Endocrinology and Metabolic Diseases Outpatient Clinic. It was calculated that a total of 89 people in three groups, 28/30 people in the groups, should be reached (n=89). The data in the second phase of the study were "Introductory Information Form for Children Diagnosed with Type 1 Diabetes", "Feeling Good-Living Life Scale" and "State-Trait Anxiety Inventory for Children", "What Did You Feel Today? Spiritual Diary" and "What Did You Do Today?Diary" It will be obtained through.


Description:

Inclusion Criteria: Age range of 9-12, Diagnosed with Type 1 Diabetes at least one year ago, Having no other physiological or psychological diseases, No mental disability Does not use psychoactive drugs, Speaking and understanding Turkish, Able to read and write Parents who volunteer their child to participate in the research and sign the consent form, Children in good physical condition were included in the study. Exclusion Criteria: Age range not 9-12, Diagnosed with Type 1 Diabetes for less than a year, Having other physiological and psychological diseases, Mentally disabled, Using psychoactive drugs, Can't speak or understand Turkish, illiterate, Parents who do not volunteer for the child to participate in the research, Children who were not in good physical time and had pain were not included in the study.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - Age range of 9-12, - Diagnosed with Type 1 Diabetes at least one year ago, - Having no other physiological or psychological diseases, - No mental disability - Does not use psychoactive drugs, - Speaking and understanding Turkish, - Able to read and write - Parents who volunteer their child to participate in the research and sign the consent form, - Children in good physical condition were included in the study. Exclusion Criteria: - Age range not 9-12, - Diagnosed with Type 1 Diabetes for less than a year, - Having other physiological and psychological diseases, - Mentally disabled, - Using psychoactive drugs, - Can't speak or understand Turkish, - illiterate, - Parents who do not volunteer for the child to participate in the research, - Children who were not in good physical time and had pain were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Diary
spiritual diary group and diary gruop will write a diary

Locations

Country Name City State
Turkey Bahçesehir University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Yeditepe University Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Parilakova M, Babincak P. Feeling Good, Living Life: Evaluation of Psychometric Properties of the Slovak Version in Children Age 8-11 Years. J Relig Health. 2020 Jun;59(3):1421-1433. doi: 10.1007/s10943-019-00867-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Spritual well-being Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale 4 weeks
Primary Anxiety Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children 4 weeks
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