NCT05377918

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

January 21, 2022

Last Update Submit

May 11, 2022

Conditions

Keywords

spiritualitychildrenanxiety

Outcome Measures

Primary Outcomes (2)

  • Spritual well-being

    Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale

    4 weeks

  • Anxiety

    Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children

    4 weeks

Study Arms (3)

Spiritual Diary Group

EXPERIMENTAL

-What did you feel today? Spiritual Diary: According to the randomization, the participants in Cluster 1 were asked to write their bad/good memories about the four elements (self, others/family, nature, God/God) in John Fisher's Four Domains model, ask family, others, and God/ God was asked to write down his wishes and wishes, and the child in this group generally wrote the question "What did I feel today?" in his diary.

Other: Diary

Diary Group

EXPERIMENTAL

What Did You Do Today? Diary: According to randomization, the children in the Cluster 2 group were asked to write down their daily activities and activities (eating, watching TV, time spent with their friends at school, etc.) and the children in this group were asked to generally ask, "What did I do today?" answered the question.

Other: Diary

Control Group

NO INTERVENTION

Control Group

Interventions

DiaryOTHER

spiritual diary group and diary gruop will write a diary

Also known as: writing a diary
Diary GroupSpiritual Diary Group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University

Istanbul, 34353, Turkey (Türkiye)

Location

Related 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.

    PMID: 31250163BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: There will be three groups in the study. Spiritual Diary Group will be asked to keep a spiritual diary "What Did You Feel Today? The children in Diary Gruop will be asked to keep a diary of "What did You do today? 3 days a week for 4 weeks, and Control Group will be the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

January 21, 2022

First Posted

May 17, 2022

Study Start

January 31, 2022

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations