NCT05544279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

September 9, 2022

Last Update Submit

September 15, 2022

Conditions

Hydrocephalus

Keywords

hydrocephaluschildrencaregiver burdenanxiety

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    through study completion, 1 month

Study Arms (2)

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.

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.

Interventions

EducationBEHAVIORAL

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

Intervention group that given education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt is aimed to assess the caregiver burden of mothers, therefore just female are included.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova University Balcalı Hospital Health Education and Research Center

Adana, Sarıçam, 01330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HydrocephalusCaregiver BurdenAnxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ayda Çelebioğlu, PhD, RN

    Mersin University

    STUDY CHAIR

Central Study Contacts

Dilara Keklik, MSc, RN

CONTACT

+905304565913dkkeklik@gmail.com

Evşen Nazik, PhD, RN

CONTACT

+905054525263eceevsen_61@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 2 groups: experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 16, 2022

Study Start

July 17, 2020

Primary Completion

October 31, 2022

Study Completion

December 30, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

TU(1)