Clinical trial NCT05544279: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hydrocephalus
Keywords: hydrocephalus
children
caregiver burden
anxiety
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 groups: experimental and control groups.
Primary purpose: SUPPORTIVE_CARE

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;

1. Having children with hydrocephalus aged 0-1 years
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. Not having another relative with chronical disease to care for
7. Residing in Adana province
8. 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.

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.

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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.

Primary outcomes:
measure: Zarit Burden Interview
timeFrame: through study completion,1 month
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: through study completion, 1 month
measure: Patient Follow-up form
timeFrame: through study completion, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University Balcalı Hospital Health Education and Research Center
state: Sarıçam
Study officials:
affiliation: Mersin University
name: Ayda Çelebioğlu, PhD, RN
role: STUDY_CHAIR
References: