Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05544279 |
| Other study ID # |
99 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 17, 2020 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Cukurova University |
| Contact |
Dilara Keklik, MSc, RN |
| Phone |
+905304565913 |
| Email |
dkkeklik[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
