HydrocephalusNCT05544279
Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus
A study testing Education in people with Hydrocephalus, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study is being conducted in randomized controlled trial design to determine the effect of the education given to the mothers of children with hydrocephalus on caregiver burden and anxiety levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2020to 30 Dec 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Not having 0-1 year old child with hydrocephalus
- No child in the preoperative period
- Those who do not undertake the primary care of the child
- illiterate
- Having no other dependents with chronic diseases at home
- Those who do not reside in Adana
- Not open to communication and cooperation
- Mothers with hearing and speech disabilities were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çukurova University Balcalı Hospital Health Education and Research Center
Adana, Sarıçam, 01330
Deniz Bolat, Employee, +903223386060, hastane@cu.edu.tr
About this study
Official title: The Effect of Education Given to the Mothers of Children With Hydrocephalus on Caregiver Burden and Anxiety
This study is being conducted in randomized controlled trial design to determine the effect of the education given to the mothers of children with hydrocephalus on caregiver burden and anxiety levels.
Read the detailed description
The number of samples to be taken was calculated as a result of the analysis of the scale mean scores in the control group data obtained in the pre-application. At the end of the 3rd measurement, under the assumption that there will be a 20% more decrease in the intervention group compared to the control group, and using the values obtained from the pilot study, it was determined that 20 patients should be included in the experimental and control groups at 5% error, 80% power.
Research eligibility criteria were as follows;
- Having children with hydrocephalus aged 0-1 years
- Having a child with a ventriculoperitoneal shunt operation indication,
- Having a child in the preoperative period
- Being the primary caregiver of the child
- Being literate
- Not having another relative with chronical disease to care for
- Residing in Adana province
- Mothers who were open to communication and cooperation were included in the study.
The hypotheses of the study are as follows;
H0: Between the mothers in the control group and the treatment group; H0-1: There is no difference between the groups in terms of Zarit Burden Interview total mean scores.
H0-2: There is no difference between the groups in terms of State Anxiety Inventory total mean scores.
H03: There is no difference between the groups in terms of Trait Anxiety Inventory total mean scores.
H04: There is no relationship between the groups in terms of Zarit Burden Interview and State Anxiety Inventory total mean scores.
H05: There is no relationship between the groups in terms of Zarit Burden Interview and Trait Anxiety Inventory total mean scores.
Before collecting the data, approvals from the Ethics Board (15 May,2020;99) and from the instituations where the study to be conducted were gained. Besides, principles namely "Informed Consent," "Confidentiality and Protection of Confidentiality," and "Respect to Autonomy" principles were fulfilled by explaining the aim of the study to the participants, by reporting that the information obtained would be kept confidential, and by including the individuals who voluntarily wanted to participate in the study.
Zarit Burden Interview, State-Trait Anxiety Inventory and Personal Information Form and Patient Follow-up Form are being used for collecting data. Totally, it was planned to make 7 interviews with the experimental group and 3 interviews with the control group and 3 measurements are made in the experimental and control groups.
Data is being collected with the first interview face-to-face and the last interview with the telephone interview technique. Training booklet was assessed by 5 lecturers in the field of Child Health and Diseases Nursing according to a kind of DISCERN measuring instrument- The Suitability of Written Materials Form. As a result of the analysis, the total score obtained from The Suitability of Written Materials Form was found to be 26.2±1.09, which indicates that the readability rate of the training content is also high. Furthermore, as a result of the evaluation of five experts in the field, necessary changes were made in the training material.
Training about the content in the booklet and the booklet were given to the experimental group in the first meeting. Each training takes about 45 minutes. Booklets in pdf formats are sent to the control group via whatsApp after the interviews were completed.
The content of the training material is topics related to hydracephalus such as what hydrocephalus is, symptoms of hydrocephalus, treatment of hydrocephalus, what shunt is, signs of infection, nutrition and what to do to prevent complications.
- Conditions
- Hydrocephalus
- Being tested
- Education
- Keywords
- hydrocephalus, children, caregiver burden, anxiety
- Medical subject headings
- Hydrocephalus, Caregiver Burden, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education is given about the focused disease and its nursing care management
| Study group | Role | What they receive |
|---|---|---|
| Intervention group that given education | Experimental | 7 interviews are held. 3 meaurements are explored. In the first measurement (first interview) "Personal information form", Zarit Burden Interview (ZBI), STAI-S and STAI-T are filled in preoperatively within 24-48 hours, and the planned training and booklet are given. Second measurement (4th interview) is done on the phone within the 1st week after discharge. Third measurement (7th interview) is explored within the 4th week after discharge. In the interim interviews, the training is repeated and the questions about the places that were not understood are answered. Receives: Behavioral: Education |
| Control group | No intervention | 1. Interview (pre-test): 1st interview: Personal information form, ZBI, STAI were filled in preoperatively within 24-48 hours. They receive routine care at the hospital 2nd interview (on the phone within the 1st week after discharge): ZBYÖ, STAI-S and Education follow-up form are filled. 3rd interview (post-test): ZBYÖ, STAI-S and Education follow-up forms were filled on the phone within the 4th week after discharge. A pdf format of the training material was sent to the mothers in the control group via whatsapp application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Burden Interview
The scale, which is used to evaluate the caregiving difficulties experienced by caregivers of individuals in need of care, was developed by Zarit, Reever, and Bach-Peterson (1980) in 1980. The Turkish validity and reliability study of the scale was carried out by İnci and Erdem (2006).
Measured: through study completion,1 month
State-Trait Anxiety Inventory (STAI)
Spielberger et al. developed it in 1970 and the validity and reliability study of this scale was carried out by Öner and Le Compte in 1977.
Measured: through study completion, 1 month
Patient Follow-up form
The training follow-up form, which was created by the researcher as a result of the literature review, was filled in twice in the 1st week and 1st month after the first interview. The purpose of this form; To determine the educational issues that the mother needs after discharge and to follow up the shunt complications.
Measured: through study completion, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start17 Jul 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Model description
- There are 2 groups: experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Keklik, Cukurova University
- Investigators
- Ayda Çelebioğlu, PhD, RN, Study chair, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544279
- Sponsor's protocol ID
- 99
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to the Mothers of Children With Hydrocephalus on Caregiver Burden and Anxiety
- ClinicalTrials.gov ID
- NCT05544279
- Acronym / sponsor ID
- 99
- Conditions
- Hydrocephalus
- Keywords
- hydrocephalus, children, caregiver burden, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 Sep 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.
This study is being conducted in randomized controlled trial design to determine the effect of the education given to the mothers of children with hydrocephalus on caregiver burden and anxiety levels.
Detailed description
The number of samples to be taken was calculated as a result of the analysis of the scale mean scores in the control group data obtained in the pre-application. At the end of the 3rd measurement, under the assumption that there will be a 20% more decrease in the intervention group compared to the control group, and using the values obtained from the pilot study, it was determined that 20 patients should be included in the experimental and control groups at 5% error, 80% power.
Research eligibility criteria were as follows;
- Having children with hydrocephalus aged 0-1 years
- Having a child with a ventriculoperitoneal shunt operation indication,
- Having a child in the preoperative period
- Being the primary caregiver of the child
- Being literate
- Not having another relative with chronical disease to care for
- Residing in Adana province
- Mothers who were open to communication and cooperation were included in the study.
The hypotheses of the study are as follows;
H0: Between the mothers in the control group and the treatment group; H0-1: There is no difference between the groups in terms of Zarit Burden Interview total mean scores.
H0-2: There is no difference between the groups in terms of State Anxiety Inventory total mean scores.
H03: There is no difference between the groups in terms of Trait Anxiety Inventory total mean scores.
H04: There is no relationship between the groups in terms of Zarit Burden Interview and State Anxiety Inventory total mean scores.
H05: There is no relationship between the groups in terms of Zarit Burden Interview and Trait Anxiety Inventory total mean scores.
Before collecting the data, approvals from the Ethics Board (15 May,2020;99) and from the instituations where the study to be conducted were gained. Besides, principles namely "Informed Consent," "Confidentiality and Protection of Confidentiality," and "Respect to Autonomy" principles were fulfilled by explaining the aim of the study to the participants, by reporting that the information obtained would be kept confidential, and by including the individuals who voluntarily wanted to participate in the study.
Zarit Burden Interview, State-Trait Anxiety Inventory and Personal Information Form and Patient Follow-up Form are being used for collecting data. Totally, it was planned to make 7 interviews with the experimental group and 3 interviews with the control group and 3 measurements are made in the experimental and control groups.
Data is being collected with the first interview face-to-face and the last interview with the telephone interview technique. Training booklet was assessed by 5 lecturers in the field of Child Health and Diseases Nursing according to a kind of DISCERN measuring instrument- The Suitability of Written Materials Form. As a result of the analysis, the total score obtained from The Suitability of Written Materials Form was found to be 26.2±1.09, which indicates that the readability rate of the training content is also high. Furthermore, as a result of the evaluation of five experts in the field, necessary changes were made in the training material.
Training about the content in the booklet and the booklet were given to the experimental group in the first meeting. Each training takes about 45 minutes. Booklets in pdf formats are sent to the control group via whatsApp after the interviews were completed.
The content of the training material is topics related to hydracephalus such as what hydrocephalus is, symptoms of hydrocephalus, treatment of hydrocephalus, what shunt is, signs of infection, nutrition and what to do to prevent complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 groups: experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention group that given education | Experimental | Behavioral: Education7 interviews are held. 3 meaurements are explored. In the first measurement (first interview) "Personal information form", Zarit Burden Interview (ZBI), STAI-S and STAI-T are filled in preoperatively within 24-48 hours, and the planned training and booklet are given. Second measurement (4th interview) is done on the phone within the 1st week after discharge. Third measurement (7th interview) is explored within the 4th week after discharge. In the interim interviews, the training is repeated and the questions about the places that were not understood are answered. |
| Control group | No intervention | –1. Interview (pre-test): 1st interview: Personal information form, ZBI, STAI were filled in preoperatively within 24-48 hours. They receive routine care at the hospital 2nd interview (on the phone within the 1st week after discharge): ZBYÖ, STAI-S and Education follow-up form are filled. 3rd interview (post-test): ZBYÖ, STAI-S and Education follow-up forms were filled on the phone within the 4th week after discharge. A pdf format of the training material was sent to the mothers in the control group via whatsapp application. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Not having 0-1 year old child with hydrocephalus
- No child in the preoperative period
- Those who do not undertake the primary care of the child
- illiterate
- Having no other dependents with chronic diseases at home
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 |
|---|---|---|
| EducationEducation is given about the focused disease and its nursing care management | Behavioural | Intervention group that given education |
Primary outcome
Zarit Burden Interview
Time frame: through study completion,1 month
The scale, which is used to evaluate the caregiving difficulties experienced by caregivers of individuals in need of care, was developed by Zarit, Reever, and Bach-Peterson (1980) in 1980. The Turkish validity and reliability study of the scale was carried out by İnci and Erdem (2006).
State-Trait Anxiety Inventory (STAI)
Time frame: through study completion, 1 month
Spielberger et al. developed it in 1970 and the validity and reliability study of this scale was carried out by Öner and Le Compte in 1977.
Patient Follow-up form
Time frame: through study completion, 1 month
The training follow-up form, which was created by the researcher as a result of the literature review, was filled in twice in the 1st week and 1st month after the first interview. The purpose of this form; To determine the educational issues that the mother needs after discharge and to follow up the shunt complications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
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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.
Ayda Çelebioğlu, PhD, RN study chair
Mersin University
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 Hydrocephalus, run by Cukurova 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 0 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilara Keklik, MSc, RN (+905304565913, dkkeklik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Burden Interview (time frame: through study completion,1 month). The study lists 3 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 16 Sep 2022.