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The Effect Of The Spiritual Diary In Children

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diary
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type 1 focused on measuring spirituality, children, anxiety

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bahçeşehir University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Spiritual Diary Group

Diary Group

Control Group

Arm Description

-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.

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.

Control Group

Outcomes

Primary Outcome Measures

Spritual well-being
Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale
Anxiety
Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children

Secondary Outcome Measures

Full Information

First Posted
January 21, 2022
Last Updated
May 11, 2022
Sponsor
Yeditepe University
Collaborators
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05377918
Brief Title
The Effect Of The Spiritual Diary In Children
Official Title
The Effect Of The Spiritual Diary On Anxiety and Spiriutal Well-Being In Children Diagnosed With Type1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
Collaborators
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
spirituality, children, anxiety

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spiritual Diary Group
Arm Type
Experimental
Arm Description
-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.
Arm Title
Diary Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Other
Intervention Name(s)
Diary
Other Intervention Name(s)
writing a diary
Intervention Description
spiritual diary group and diary gruop will write a diary
Primary Outcome Measure Information:
Title
Spritual well-being
Description
Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale
Time Frame
4 weeks
Title
Anxiety
Description
Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bahçeşehir University
City
İstanbul
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31250163
Citation
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.
Results Reference
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The Effect Of The Spiritual Diary In Children

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