Diabetes Mellitus, Type 1NCT05377918
The Effect Of The Spiritual Diary In Children
A study testing Diary in people with Diabetes Mellitus, Type 1, run by Yeditepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of The Spiritual Diary On Anxiety and Spiriutal Well-Being In Children Diagnosed With Type1 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Diary
- Keywords
- spirituality, children, anxiety
- Medical subject headings
- Diabetes Mellitus, Type 1, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryOther
Also called writing a diary
spiritual diary group and diary gruop will write a diary
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Diary |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spritual well-being
Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale
Measured: 4 weeks
Anxiety
Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Jan 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Bahçeşehir University
- Responsible party
- Principal investigator, Tugce atak meric, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377918
- Sponsor's protocol ID
- B-TUGCEATAKMERİC-001
- Status last verified
- May 2022
- First submitted
- 21 Jan 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31250163
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of The Spiritual Diary On Anxiety and Spiriutal Well-Being In Children Diagnosed With Type1 Diabetes
- ClinicalTrials.gov ID
- NCT05377918
- Acronym / sponsor ID
- B-TUGCEATAKMERİC-001
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- spirituality, children, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Bahçeşehir University
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spiritual Diary Group | Experimental | Other: Diary-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. |
| Diary Group | Experimental | Other: DiaryWhat 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 | No intervention | –Control Group |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiaryAlso: writing a diaryspiritual diary group and diary gruop will write a diary | Other | Diary Group, Spiritual Diary Group |
Primary outcome
Spritual well-being
Time frame: 4 weeks
Children's spiritual well-being will be evaluated with Feeling Good Living Life Scale
Anxiety
Time frame: 4 weeks
Chilren's anxiety level will be evaluated with State-trait Anxiety Invetory for Children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 31250163Parilakova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diary in people with Diabetes Mellitus, Type 1, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spritual well-being (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05377918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.