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Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus

Primary Purpose

Hydrocephalus

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hydrocephalus focused on measuring hydrocephalus, children, caregiver burden, anxiety

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1. Having children aged 0-1 with hydrocephalus 2. Having a child with a ventriculoperitoneal shunt operation indication, 3. Having a child in the preoperative period 4. Being the primary caregiver of the child 5. Being literate 6. Having no other dependents with chronic diseases at home 7. Residing in Adana province 8. Mothers who were open to communication and cooperation were included in the study.

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Exclusion Criteria:

  1. Not having 0-1 year old child with hydrocephalus
  2. No child in the preoperative period
  3. Those who do not undertake the primary care of the child
  4. illiterate
  5. Having no other dependents with chronic diseases at home
  6. Those who do not reside in Adana
  7. Not open to communication and cooperation
  8. Mothers with hearing and speech disabilities were excluded from the study.

Sites / Locations

  • Çukurova University Balcalı Hospital Health Education and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group that given education

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
September 15, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05544279
Brief Title
Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus
Official Title
The Effect of Education Given to the Mothers of Children With Hydrocephalus on Caregiver Burden and Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus
Keywords
hydrocephalus, children, caregiver burden, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 2 groups: experimental and control groups.
Masking
None (Open Label)
Masking Description
No masking
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group that given education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
Education is given about the focused disease and its nursing care management
Primary Outcome Measure Information:
Title
Zarit Burden Interview
Description
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).
Time Frame
through study completion,1 month
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
through study completion, 1 month
Title
Patient Follow-up form
Description
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.
Time Frame
through study completion, 1 month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
It is aimed to assess the caregiver burden of mothers, therefore just female are included.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Having children aged 0-1 with hydrocephalus 2. Having a child with a ventriculoperitoneal shunt operation indication, 3. Having a child in the preoperative period 4. Being the primary caregiver of the child 5. Being literate 6. Having no other dependents with chronic diseases at home 7. Residing in Adana province 8. Mothers who were open to communication and cooperation were included in the study. - Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dilara Keklik, MSc, RN
Phone
+905304565913
Email
dkkeklik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Evşen Nazik, PhD, RN
Phone
+905054525263
Email
eceevsen_61@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayda Çelebioğlu, PhD, RN
Organizational Affiliation
Mersin University
Official's Role
Study Chair
Facility Information:
Facility Name
Çukurova University Balcalı Hospital Health Education and Research Center
City
Adana
State/Province
Sarıçam
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deniz Bolat, Employee
Phone
+903223386060
Email
hastane@cu.edu.tr

12. IPD Sharing Statement

Learn more about this trial

Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus

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