跳至主要内容
临床试验/NCT05969535
NCT05969535已完成不适用

The Effect of Education Given Accordıng to the Travelbee Human Human Relatıons Model On Prenatal Attachment, Birth Fear and Anxiety in Pregnants With Fear of Birth

Tuğba Sarı2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Prenatal Attachment Inventory (PAI)

研究概览

简要总结

Communication between nurse and patient is considered essential to provide holistic and humane care as it allows patients to be fully understood, assisted, and their needs defined as empathetic. Travelbee, states that nursing is conducted through human-to-human relationships. These relationships begin first with the encounter of the nurse and the patient, then with the stage of emergence of identities where the relationship begins, the stage in which the nurse and the patient perceive each other's uniqueness, the empathy stage in which the person shares their experiences, the sympathy stage in which the nurse wants to reduce the cause of the patient's pain, and the final stage is the nurse and the patient's interrelated thoughts and feelings, their interest and concern towards others, a non-judgmental attitude and a person specific to each individual it consists of the stage of harmony that he approaches with respect. During this biological process, many physiological and psychological changes can be expected in pregnant women. Many psychological and social factors influence the fear of childbirth. These factors include; Lack of self-confidence in childbirth, being affected by negative birth histories, history of depression, anxiety, partner dissatisfaction, young maternal age, low income level, low education and low perception of social support, pain in childbirth or fear of losing control, and physical injury during childbirth. It is also possible that the fear of childbirth and the appearance of symptoms of stress and anxiety, which complicates pregnancy. Mother-infant bonding, which is adversely affected by mental problems such as anxiety, depression and fear of childbirth during pregnancy, can adversely affect the attachment process in both prenatal period. There are some non-pharmaceutical applications to strengthen the mental health of the mother, to reduce stress and fear of childbirth, and to strengthen the mother-baby bond. These are practices that include listening to music, psychoeducation, cognitive and behavioral therapies. With professional support in this study, childbirth will take place in a completely safe environment where stress and fear of childbirth are less. Nurses need to communicate from person to person in order to achieve the goal of effective care and to be healing. The training program was created based on Travelbee's five-step human-to-human relationship model with pregnant women who fear childbirth.

详细描述

Type of Research The research will be conducted as a randomized controlled treatment study aimed at directing the education given according to the Travelbee human explanation theory to the fear of birth, prenatal retention and anxiety in primiparous pregnant women who have fear of childbirth.

The Universe of the Research The population of the research consists of primiparous pregnant women who came to the Obstetrics and Gynecology outpatient clinic between July 2023 and October 2023.

Sample of the Research G*Power version 3.1.9.7 program was used to calculate the size and power value of the research sample. It was calculated by taking a reference to a study done in the sample size calculation. According to the G power analysis, 5% margin of error, 95% power (representing the universe) and an effect size of 1.031 were calculated as 26 in total, 52 in both groups. As the main parameter of the study in the selection of the sample, the pregnant women with moderate and high level of fear of childbirth score from the Wijma Birth Expectation / Experience Scale (W-DEQ) Version A scale will be selected. In the literature review, the fear of childbirth starts from the 20th week of pregnancy and increases during pregnancy. Therefore, pregnant women with 20th gestational week and older than this week were included in the study. In order for the training program to be 4 weeks and for the participating pregnant women to complete prenatal education, pregnant women after 34 weeks were not included. Considering the loss of pregnant women who met the research criteria and accepted to participate in the study, the sample size was determined as 70 participants, 35 for both groups.

Formation of the Control and Experimental Group After meeting the pregnant women who came for the routine pregnancy examination and evaluating whether it was the first pregnancy according to the research criteria, the Personal Information Form and the Wijma Birth Expectation / Experience Scale Version A scale were filled out by the pregnant women who met the inclusion criteria. Pregnant women with a medium or higher fear of childbirth score were informed about the study and their verbal and written consent was obtained from the voluntary consent form. In addition, a list has been prepared including the name and surname of the pregnant women, the estimated date of birth according to the last menstrual period, and contact information.

Randomization Randomization technique was used to assign participants to groups. The stratification randomization technique will be used to ensure homogeneity according to the data obtained from the pregnant women (educational status, age and fear of childbirth).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • 18 years and over.
  • At least primary school graduate.
  • According to the last menstrual period or for pregnant women who do not know the last menstruation date, to be between 20-34 weeks in the calculations made with USG data.
  • Intermediate and higher score on the Wijma birth expectancy/experience scale version A.
  • Having a single and live pregnancy.
  • Having your first pregnancy.
  • Agreeing to participate in the research.
  • Having trouble communicating.
  • No infertility treatment.
  • No contraindications for vaginal delivery

排除标准

  • Pregnant women with medical indications.
  • Those with high-risk pregnancies.
  • Having given birth before.

结局指标

主要结局

Prenatal Attachment Inventory (PAI)

时间窗: each participant pregnant will be evaluated for outcome measure for four weeks

Prenatal attachment inventory was developed to explain the thoughts, feelings and experiences of pregnant women and to determine mother-baby attachment levels. The scale is applied to pregnant women in the 20th and 40th weeks of pregnancy. The scale consists of 21 items. A minimum of 21 points and a maximum of 84 points can be obtained from the scale. An increase in the score indicates that the level of attachment to the baby also increases. The Cronbach Alpha reliability coefficient of the scale was stated as 0.84.

Wijma Birth Expectation/Experience Scale (W-DEQ) Version A

时间窗: each participant pregnant will be evaluated for outcome measure for four weeks

It is a scale developed to determine the birth fear and stress of pregnant women. W-DEQ version A is a 6-point Likert-type scale consisting of 33 items. While the minimum score on the scale is 0, the maximum score is 165. The negatively charged questions (2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31) in the scale are calculated by reversing them. A high score indicates a high level of fear of childbirth. The cutoff point is 85. A score of 85 and above indicates clinical fear of childbirth. The Cronbach's Alpha value of the scale was found to be 0.88 for primiparous pregnants and 0.90 for multiparous pregnants. * 0-37 points = mild fear of childbirth * 38-65 points = moderate fear of childbirth * 66-84 points = severe fear of childbirth * 85 and above = clinical fear of childbirth

Beck Anxiety Scale (BAI)

时间窗: each participant pregnant will be evaluated for outcome measure for four weeks

It is a scale developed to measure anxiety symptoms and reveal the cognitive aspects of anxiety. The scale consists of 21 items and is a four-point Likert type scale scored between 0-3. The lowest 0 and the highest 63 points are obtained in the scale. For each item, it is required to tick one of the options "None", "Mild", "Moderate", "Severe". 13 items evaluate physiological symptoms, 5 items describe the cognitive aspect, 3 items represent both somatic and cognitive symptoms. The high total score obtained in the scale indicates the severity of the anxiety experienced by the individual. The Cronbach alpha value of the scale was found to be 0.93.

次要结局

未报告次要终点

研究者

发起方
Tuğba Sarı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tuğba Sarı

Sponsor Investigator

Tokat Gaziosmanpasa University

研究点 (2)

Loading locations...

相似试验