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临床试验/NCT05544279
NCT05544279招募中不适用

The Effect of Education Given to the Mothers of Children With Hydrocephalus on Caregiver Burden and Anxiety

Cukurova University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

No masking

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Having children aged 0-1 with hydrocephalus
  • Having a child with a ventriculoperitoneal shunt operation indication,
  • Having a child in the preoperative period
  • Being the primary caregiver of the child
  • Being literate
  • Having no other dependents with chronic diseases at home
  • Residing in Adana province
  • Mothers who were open to communication and cooperation were included in the study.

排除标准

  • 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
  • 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.

结局指标

主要结局

State-Trait Anxiety Inventory (STAI)

时间窗: through study completion, 1 month

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.

Zarit Burden Interview

时间窗: through study completion,1 month

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).

Patient Follow-up form

时间窗: through study completion, 1 month

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilara Keklik

Research Assistant

Cukurova University

研究点 (2)

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