Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus

NCT ID: NCT05544279

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-17
• Study Completion Date: 2022-12-30

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.

Conditions

Hydrocephalus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group that given education

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Education is given about the focused disease and its nursing care management

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

Education is given about the focused disease and its nursing care management

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Dilara Keklik

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayda Çelebioğlu, PhD, RN

Role: STUDY_CHAIR

Mersin University

Locations

Çukurova University Balcalı Hospital Health Education and Research Center

Adana, Sarıçam, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Dilara Keklik, MSc, RN

Role: CONTACT

dkkeklik@gmail.com

+905304565913

Evşen Nazik, PhD, RN

Role: CONTACT

eceevsen_61@hotmail.com

+905054525263

Facility Contacts

Deniz Bolat, Employee

Role: primary

hastane@cu.edu.tr

+903223386060

Other Identifiers

99

Identifier Type: -

Identifier Source: org_study_id