Being Registered With Kelkit District State Hospital Home Health UnitNCT07053553
Determining the Effect of Home Care Training on Anxiety and Depression Levels of Caregivers
A study testing Education in people with Being Registered With Kelkit District State Hospital Home Health Unit and Being a Home Care Patient, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of home care training given to caregivers of patients receiving home care services on the anxiety and depression levels of the caregivers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Being Registered With Kelkit District State Hospital Home Health Unit, Being a Home Care Patient
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2023to 25 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being registered with the Kelkit District State Hospital Home Health Unit
- Being willing to participate in the research
- Being able to read and write in Turkish and be able to communicate
- Not having vision or hearing loss
- Being able to make phone calls
Who cannot join
- Not registered with Kelkit District State Hospital Home Health Unit
- Not volunteering to participate in the research
- Not knowing how to read and write in Turkish and not being able to communicate
- Having vision and hearing loss
- Not being able to communicate by phone
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gümüşhane University
Gümüşhane, Gümüşhane Province, 29600
About this study
This study was conducted to determine the effects of home care training given to caregivers of patients receiving home care services on the anxiety and depression levels of the caregivers. The study was conducted as a pre-test/post-test, randomized controlled quasi-experimental with a total of 42 patients and caregivers receiving home care services, 21 in the experimental group and 21 in the control group, registered at the Home Health Unit of Kelkit District State Hospital in Gümüşhane province between September 2023 and December 2024. Caregiver Information Form, Beck Anxiety Inventory, Beck Depression Inventory, and Patient Body Bath Caregiver Follow-up Form were used as data collection tools. The caregivers in the experimental group were asked about which subject they wanted to receive training, and it was determined that they wanted to receive training on in-bed body bath, and patient body bath caregiver training was planned and implemented. No application was made to the caregivers in the control group. SPSS 22 statistical program was used in the analysis of the data and the significance level was accepted as p<0.05.
Read the detailed description
The research was conducted in the homes of patients and caregivers who were registered with the Home Health Unit of Kelkit District State Hospital in Gümüşhane province and received home care services. Data collection tools were created between May and August 2023. Research data were collected between September 2023 and December 2024. The research was completed by data analysis and reporting between January and March 2025. The caregivers included in the research sample were listed consecutively according to the order of their application to the Home Health Unit of Kelkit District State Hospital in Gümüşhane province and were divided into experimental (n=23) and control (n=22) groups via the internet using the simple random sampling method. After 3 caregivers did not want to participate in the study, a study was conducted with 42 caregivers (21 experimental, 21 control). The first interview with the experimental (n=21) and control (n=21) groups was conducted face to face at the caregivers' homes, and a pre-test was conducted after the written consent form was obtained from the caregivers who agreed to participate in the study. In the pre-test application, the BVBF, Beck Anxiety Inventory, and Beck Depression Inventory were filled out. A second interview was conducted to determine the issues that the caregivers in the experimental group had difficulty with, experienced stress, felt the need for training, and wanted to receive training during care practices, and it was found that the majority of the caregivers wanted to receive patient bed bath training.After the second interview, bed bath training was planned for the caregivers of the patients in the experimental group, the training content and patient body bath caregiver follow-up forms were created, and the created training plan was sent for expert opinion in terms of suitability. After the expert opinion was received, a third interview was planned with the caregivers of the patients in the experimental group, during the interview, the caregivers were asked to apply body bath to the patient, the caregiver was observed while applying body bath to the patient, and in order to evaluate the incomplete/faulty practices of the caregiver during the application, the HVBBVİF was filled in by the researcher while the caregiver was performing the application.
1 week after the third interview, the 4th interview was conducted with the caregivers of the patients in the experimental group, and the bed bath training was demonstrated and applied by the researcher to the patient's caregiver. 1 week after the fourth interview, the 5th interview was conducted with the caregivers of the patients in the experimental group, and the HVBBVİF was filled in by the researcher while the caregiver was performing body bath to the patient, and the incomplete/faulty practices were corrected by the researcher with immediate feedback. Two weeks after the 5th interview, the 6th interview was conducted with the caregivers of the patients in the experimental group, the caregiver applied the bed bath to the patient, and the HVBBVİF was filled in by the researcher. One week after the sixth interview, the 7th interview was conducted with the experimental and control groups, and for the post-test application, the "BVBF", "Beck Anxiety Inventory", and "Beck Depression Inventory" were filled in again.
- Conditions
- Being Registered With Kelkit District State Hospital Home Health Unit, Being a Home Care Patient
- Being tested
- Education
- Keywords
- Caregivers, Health Education, Home Care, Home Nursing, Mental Health
- Medical subject headings
- Health Education, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
It was planned to provide bed bath training to inpatients because 90.5% of the caregivers of the patients in the experimental group wanted to receive bed bath training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (n=21) | Experimental | Experimental (n=21) Receives: Other: Education |
| control groups | No intervention | control (n=21) groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home care training has an effect on anxiety and depression levels of caregivers.
Beck Anxiety Inventory is a self-assessment scale. It is a Likert-type scale consisting of 21 items. According to the scale score ranges, 0-7 points indicate minimal anxiety, 8-15 points indicate mild anxiety, 16-25 points indicate moderate anxiety, and 26-63 points indicate severe anxiety. The Beck Depression Inventory was developed by Beck in 1961 to measure the risk of depression in adults, the level of depressive symptoms, and the change in severity. The scale consists of 21 items. It is a four-degree self-assessment scale. The highest score that can be obtained from the scale is 63. The cut-off score was accepted as 17. According to the scale score ranges, 0-9 points indicate minimal depressive symptoms, 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms, and 30 and above points indicate severe depressive symptoms.
Measured: from registration to the end of the 12th week
Home care training has an impact on hospital admissions of patients receiving home care services.
It is aimed to reduce the frequency of patients' hospital admissions after home care training.
Measured: from registration to the end of the 12th week
Secondary outcomes (1)
Home care training has an impact on the frequency of home care patients applying to the home care unit.
It is aimed to reduce the frequency of patients applying to home care units after home care training.
Measured: from registration to the end of the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start2 Sep 2023
- Primary completion30 Dec 2024
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Being Registered With Kelkit District State Hospital Home Health UnitStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Hatun Erkuran, Gümüşhane Universıty
- Investigators
- Havva Karadeniz, Assist.Prof.PhD, Principal investigator, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053553
- Sponsor's protocol ID
- Gumushane University
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Home Care Training on Anxiety and Depression Levels of Caregivers
- ClinicalTrials.gov ID
- NCT07053553
- Acronym / sponsor ID
- Gumushane University
- Conditions
- Being Registered With Kelkit District State Hospital Home Health Unit, Being a Home Care Patient
- Keywords
- Caregivers, Health Education, Home Care, Home Nursing, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 8 Jul 2025 (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.
This study was conducted to determine the effects of home care training given to caregivers of patients receiving home care services on the anxiety and depression levels of the caregivers. The study was conducted as a pre-test/post-test, randomized controlled quasi-experimental with a total of 42 patients and caregivers receiving home care services, 21 in the experimental group and 21 in the control group, registered at the Home Health Unit of Kelkit District State Hospital in Gümüşhane province between September 2023 and December 2024. Caregiver Information Form, Beck Anxiety Inventory, Beck Depression Inventory, and Patient Body Bath Caregiver Follow-up Form were used as data collection tools. The caregivers in the experimental group were asked about which subject they wanted to receive training, and it was determined that they wanted to receive training on in-bed body bath, and patient body bath caregiver training was planned and implemented. No application was made to the caregivers in the control group. SPSS 22 statistical program was used in the analysis of the data and the significance level was accepted as p<0.05.
Detailed description
The research was conducted in the homes of patients and caregivers who were registered with the Home Health Unit of Kelkit District State Hospital in Gümüşhane province and received home care services. Data collection tools were created between May and August 2023. Research data were collected between September 2023 and December 2024. The research was completed by data analysis and reporting between January and March 2025. The caregivers included in the research sample were listed consecutively according to the order of their application to the Home Health Unit of Kelkit District State Hospital in Gümüşhane province and were divided into experimental (n=23) and control (n=22) groups via the internet using the simple random sampling method. After 3 caregivers did not want to participate in the study, a study was conducted with 42 caregivers (21 experimental, 21 control). The first interview with the experimental (n=21) and control (n=21) groups was conducted face to face at the caregivers' homes, and a pre-test was conducted after the written consent form was obtained from the caregivers who agreed to participate in the study. In the pre-test application, the BVBF, Beck Anxiety Inventory, and Beck Depression Inventory were filled out. A second interview was conducted to determine the issues that the caregivers in the experimental group had difficulty with, experienced stress, felt the need for training, and wanted to receive training during care practices, and it was found that the majority of the caregivers wanted to receive patient bed bath training.After the second interview, bed bath training was planned for the caregivers of the patients in the experimental group, the training content and patient body bath caregiver follow-up forms were created, and the created training plan was sent for expert opinion in terms of suitability. After the expert opinion was received, a third interview was planned with the caregivers of the patients in the experimental group, during the interview, the caregivers were asked to apply body bath to the patient, the caregiver was observed while applying body bath to the patient, and in order to evaluate the incomplete/faulty practices of the caregiver during the application, the HVBBVİF was filled in by the researcher while the caregiver was performing the application.
1 week after the third interview, the 4th interview was conducted with the caregivers of the patients in the experimental group, and the bed bath training was demonstrated and applied by the researcher to the patient's caregiver. 1 week after the fourth interview, the 5th interview was conducted with the caregivers of the patients in the experimental group, and the HVBBVİF was filled in by the researcher while the caregiver was performing body bath to the patient, and the incomplete/faulty practices were corrected by the researcher with immediate feedback. Two weeks after the 5th interview, the 6th interview was conducted with the caregivers of the patients in the experimental group, the caregiver applied the bed bath to the patient, and the HVBBVİF was filled in by the researcher. One week after the sixth interview, the 7th interview was conducted with the experimental and control groups, and for the post-test application, the "BVBF", "Beck Anxiety Inventory", and "Beck Depression Inventory" were filled in again.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (n=21) | Experimental | Other: EducationExperimental (n=21) |
| control groups | No intervention | –control (n=21) groups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being registered with the Kelkit District State Hospital Home Health Unit
- Being willing to participate in the research
- Being able to read and write in Turkish and be able to communicate
- Not having vision or hearing loss
- Being able to make phone calls
Key exclusion criteria (5 listed)
- Not registered with Kelkit District State Hospital Home Health Unit
- Not volunteering to participate in the research
- Not knowing how to read and write in Turkish and not being able to communicate
- Having vision and hearing loss
- Not being able to communicate by phone
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 |
|---|---|---|
| EducationIt was planned to provide bed bath training to inpatients because 90.5% of the caregivers of the patients in the experimental group wanted to receive bed bath training. | Other | Experimental (n=21) |
Primary outcome
Home care training has an effect on anxiety and depression levels of caregivers.
Time frame: from registration to the end of the 12th week
Beck Anxiety Inventory is a self-assessment scale. It is a Likert-type scale consisting of 21 items. According to the scale score ranges, 0-7 points indicate minimal anxiety, 8-15 points indicate mild anxiety, 16-25 points indicate moderate anxiety, and 26-63 points indicate severe anxiety. The Beck Depression Inventory was developed by Beck in 1961 to measure the risk of depression in adults, the level of depressive symptoms, and the change in severity. The scale consists of 21 items. It is a four-degree self-assessment scale. The highest score that can be obtained from the scale is 63. The cut-off score was accepted as 17. According to the scale score ranges, 0-9 points indicate minimal depressive symptoms, 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms, and 30 and above points indicate severe depressive symptoms.
Home care training has an impact on hospital admissions of patients receiving home care services.
Time frame: from registration to the end of the 12th week
It is aimed to reduce the frequency of patients' hospital admissions after home care training.
1 secondary outcome
Home care training has an impact on the frequency of home care patients applying to the home care unit.
Time frame: from registration to the end of the 12th week
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 8 Jul 2025.
- Beck AnxietyLink provided by the sponsor.
- Beck Depression scalesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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.
Havva Karadeniz, Assist.Prof.PhD principal investigator
Gümüşhane Universıty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Being Registered With Kelkit District State Hospital Home Health Unit and Being a Home Care Patient, run by Gümüşhane Universıty 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 5 inclusion and 5 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 8 Jul 2025. 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?
Home care training has an effect on anxiety and depression levels of caregivers. (time frame: from registration to the end of the 12th week). 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?
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 8 Jul 2025.