ClinicalTrials.gg
Status unknownNCT05544279Updated Sep 16, 2022

Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus

An interventional study of Education in Hydrocephalus, sponsored by Cukurova University. Status unknown at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-16.

Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2020, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Hydrocephalus

Keywords

  • hydrocephalus
  • children
  • caregiver burden
  • anxiety
03

In context

Hydrocephalus

213 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

This study's planned enrollment of 40 is below the median of 49 across 106 interventional studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

Cukurova University is the lead sponsor of 258 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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:

  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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Education

  • No intervention
    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.

Interventions

  • BehavioralEducation

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: through study completion,1 month

  2. 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.

    Time frame: through study completion, 1 month

  3. 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.

    Time frame: through study completion, 1 month

07

Study locations

1 of 1 sites recruiting
  • Çukurova University Balcalı Hospital Health Education and Research Center
    Adana, Sarıçam 01330, Turkey (Türkiye)
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Oct 2022, 27 months after the start.

Of 45 interventional studies with no phase under Hydrocephalus, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 63. This study's planned 27 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2022
First posted
Sep 16, 2022
StartActual
Jul 17, 2020
Primary completionEst.
Oct 31, 2022
CompletionEst.
Dec 30, 2022
Last update
Sep 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05544279
Responsible party
Dilara Keklik (Research Assistant, Cukurova University) — Principal investigator
First posted
Sep 16, 2022
Start date
Jul 17, 2020
Primary completion
Oct 31, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Sep 16, 2022

Study contacts

Dilara Keklik, MSc, RN
Contact
dkkeklik@gmail.com
+905304565913
Evşen Nazik, PhD, RN
Contact
eceevsen_61@hotmail.com
+905054525263
Ayda Çelebioğlu, PhD, RN
study chair · Mersin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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