跳至主要内容
临床试验/NCT06997211
NCT06997211尚未招募不适用

The Effect of the Emotional Freedom Technique Applied to Mothers With Premature Babies in the Intensive Care Unit on Fatigue, Anxiety, and Mother-Baby Bonding

Bezmialem Vakif University0 个研究点目标入组 64 人开始时间: 2025年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
Fatigue, Anxiety, and Mother-Baby Bonding and Effect of the Emotional Freedom

研究概览

简要总结

Fatigue, Anxiety, and Mother-Baby Bonding and Emotional Freedom Technique

详细描述

Type of research: This study is a randomized controlled experimental study designed according to the Consolidated Standards of Reporting Trials (CONSORT) guideline.

Place of the research: Bezmialem Vakıf University Central Hospital Neonatal Intensive Care Unit and Obstetrics and Gynecology Service, Bezmialem Vakıf University Dragos Hospital Neonatal Intensive Care Unit and gynecology service.

Population of the Research: The population of the research consists of mothers of premature newborns who were hospitalized in Bezmialem Vakıf University Central Hospital Neonatal Intensive Care Unit and Bezmialem Vakıf University Dragos Hospital Newborn Intensive Care Unit on the study dates.

Research Sample: Power analysis was conducted to determine the number of people to be included in the research. The power of the test was calculated with the G*Power 3.1 program. the effect size regarding state anxiety change was calculated as 0.866. In order to exceed the 99% value in determining the power of the study; At a significance level of 5% and an effect size of 0.866, 54 people, 27 people in the groups, need to be reached (df=26; t=2.056). In the research, it was aimed to reach a total of 64 people, 32 people in the groups, considering the high power of the test and the losses.

Analysis of Data: It was planned to use SPSS (Statistical Package for Social Sciences) for Windows 22.0 program for the statistics of the data obtained in the research. Number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. Differences between the rates of categorical variables in independent groups are planned to be analyzed with Chi-Square tests. The t-test will be used to compare quantitative continuous data between two independent groups, and the changes in repeated measurements within the group will be analyzed with the dependent groups t-test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • •Those who can read and write and who can speak and understand Turkish,
  • •Those whose STAI-I (status) score range is 40 and above
  • •Mothers whose babies were born prematurely
  • •Mothers whose babies are in NICU,
  • •Mothers who agreed to participate in the study.

排除标准

  • •Mothers of premature newborns who cannot be fed with breast milk,
  • •Mothers who were discharged during the study sessions and did not agree to continue working,
  • •The mother has any cognitive or hearing-related problems,
  • •The mother has a psychiatrically diagnosed disease (Schizophrenia, bipolar disorder, depression).
  • •Having epilepsy (since it is contraindicated for EFT applications)

研究组 & 干预措施

EXPERİMENTAL: EFT GROUP

Experimental

Steps for the Intervention Group:

Pre-Intervention:

  • Participants in the intervention group will be informed about EFT, and after explaining the aim and method of the study, their consent will be obtained using the Volunteer Consent Form.
  • They will complete the State-Trait Anxiety Inventory (STAI), and those who score 40 or higher will be included in the study.
  • Afterward, information will be provided about EFT, including how the procedure will be performed and how tapping will be done. Following a discussion planned to last approximately 20 minutes, the EFT session will begin.
  • Prior to the intervention, women will be asked to fill out the Descriptive Information Form, State-Trait Anxiety Inventory (STAI-I), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) forms.
  1. EFT Procedure Sequence:
  • The first meeting will be conducted within the first 24 hours after the admission of mothers who meet the inclusion criteria for our study in the NICU.
  • T

干预措施: EFT (Behavioral)

CONTROL GROUP

No Intervention

Control Group Application Steps:

Control Group 1st Meeting (Pre-test):

The mothers in the control group, who have premature babies in the neonatal intensive care unit, will be informed about the study. After explaining the purpose and method of the study, their consent will be obtained through the Volunteer Consent Form.

The women will complete the forms, and those with a score of 40 or above will be included in the study.

The women in the control group will be asked to complete the Descriptive Information Form, State-Trait Anxiety Inventory (STAI I-II), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) forms.

No intervention will be provided for the mothers in the control group, but the institution's neonatal intensive care services will be available to them.

Control Group 2nd Meeting:

One week after the first meeting, the State-Trait Anxiety Inventory (STAI I-II), Visual Similarity Scale for Fatigue (YİGBS), and Mother-Infant Bonding Scale (MIBS) fo

结局指标

主要结局

Fatigue, Anxiety, and Mother-Baby Bonding and Effect of the Emotional Freedom

时间窗: 2 year

1. Visual Similarity Scale for Fatigue (VSSF): This is a visual analog scale designed to assess an individual's subjective level of fatigue. Participants are presented with a straight line anchored by the descriptors "not at all fatigued" (0 points) on one end and "extremely fatigued" (10 points) on the other. Participants are asked to mark the point on the line that best represents their current fatigue level. Scores range from a minimum of 0 to a maximum of 10. Higher scores indicate a higher level of perceived fatigue. This scale is widely used in clinical settings due to its simplicity and efficiency.

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

Merve Meşedüzü

LECTURER

Bezmialem Vakif University

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