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临床试验/NCT07074197
NCT07074197
已完成
不适用

The Effect of Smelling the Scent of Infants Hospitalized in the Neonatal Intensive Care Unit on Mothers' Stress, Attachment and Perception of Insufficient Milk

T.C. ORDU ÜNİVERSİTESİ1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月15日最近更新:

概览

阶段
不适用
状态
已完成
发起方
T.C. ORDU ÜNİVERSİTESİ
入组人数
60
试验地点
1
主要终点
Neonatal Intensive Care Parent Stress Scale

概览

简要总结

The study was conducted to determine the effect of having mothers with infants in the neonatal intensive care unit smell their baby's odor with OOKIE dolls on stress, attachment and perception of insufficient milk.

详细描述

The infant who met the study selection criteria was wrapped with OOCIE upon admission and remained in contact with OOCIE for approximately 24 hours without affecting routine care and positioning. After 24 hours, when the mother came for the first visit, the mother and baby introductory information form, Neonatal Intensive Care Unit Parent Stress Scale, Inadequate Milk Perception Scale, Mother-Infant Attachment Scale and NICU Parental Beliefs Scale pretest were administered. During the visit, the mother took the OOKIE wrapped around her baby in the incubator and stayed with the mother for 3 days and the mother could smell her baby's odor whenever she wanted.

OOKIE, which will be used in the study, is a doll made of 100% cotton flannel fabric, with satin edges, 35cmx 40cm in size and produced in various colors. Due to its structure, it can be easily washed, dried and sterilized. The fabric feature is capable of trapping and transferring odor. It is a suitable tool for mothers who are separated from their babies in the intensive care environment, which can mediate the smell of their babies.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

After the mothers of newborns who met the inclusion criteria were randomly assigned to the study groups, written informed consent was obtained without informing the parents about which group their infants would be included in. The researcher placed the OOKIE baby next to the infant herself and then gave it to the mother, so the researcher was not blinded. However, to avoid bias, the outcome measures were recorded by two nurses working in the NICU, who were university graduates and did not know which mother was in the experimental or control group. To avoid bias during data analysis, the database of the study groups was coded as A and B by someone other than the researcher, and the data were analyzed by an independent statistician. Blinding of outcome measurements, statistical analysis and reporting was performed to prevent statistical and reporting bias.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The mother's voluntary acceptance to participate in the study.
  • The baby received treatment for at least 3 days in the NICU,
  • The baby did not have any congenital anomaly, and the baby did not undergo any surgical procedure.

排除标准

  • Mother's illiteracy,
  • Mother's having an obstacle to communication,
  • Referral of the baby to another center,
  • Mother's having an obstacle to breastfeeding or mothers who do not want to breastfeed,
  • Mother's having an olfactory problem.

结局指标

主要结局

Neonatal Intensive Care Parent Stress Scale

时间窗: 1-4. day

Parents were asked to rate the level of stress caused by each of the factors in the scale from one (no stressor) to five (extreme stressor). Factors with a mean score between 3.0 and 3.40 are considered moderately stressful, and factors with a mean score \>3.40 are considered very stressful. Stress factors are analyzed in 3 subgroups. The first is the "Sights and Sounds" subgroup, which includes factors such as the presence of equipment on the baby or in the intensive care unit, sounds arising from them and the environment. The second is the "Appearance and Behavior of the Baby" subgroup, and the third is the factors related to the "Role of the Parents". While filling in the statements such as the presence of tubes and other equipment on or near the baby, sudden change in the baby's color or the baby's breathing stopping, mothers whose babies did not have these symptoms did not mark these items.

Inadequate Milk Perception Scale

时间窗: 1-4. day

The inadequate milk perception scale is a form consisting of 6 questions. In the first question, the mother is asked whether she believes that she is feeding her baby enough. The mother answers this question as "yes" or "no". The other questions of the scale aim to measure the perception of milk insufficiency. The mother is asked to score these questions between 0-10. "0" indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. A minimum score of 0 and a maximum score of 50 can be obtained from the scale. A higher total score indicates a higher perception of milk adequacy. In the original scale, Cronbach α value was determined as 0.81.

Mother-Infant Attachment Scale

时间窗: 1-4.day

The scale is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word. The Mother-Infant Attachment Scale (MICS) is a 4-point Likert scale consisting of 8 items. The responses consisting of four options are scored between 0-3, with the lowest score being 0 and the highest score being 24. In the evaluation, items 1, 4, and 6 are positive emotion expressions and are scored as 0,1,2,3, while items 2, 3, 5, 7, and 8 are negative emotion expressions and are scored as 3,2,1,0.

NICU Parental Beliefs Scale

时间窗: 1-4.day

The scale is a 5-point Likert-type scale consisting of a total of 18 items. Each item is scored from 1 (strongly disagree) to 5 (strongly agree). The highest score that can be obtained from the scale is 90 and the lowest score is 18. The scale has three sub-dimensions: Parental Role Confidence, Parent-Baby Interaction and Knowledge of the NICU. Higher scores indicate higher parental beliefs and lower scores indicate lower parental beliefs.

次要结局

未报告次要终点

研究者

发起方
T.C. ORDU ÜNİVERSİTESİ
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Kucuk Alemdar

Professor

T.C. ORDU ÜNİVERSİTESİ

研究点 (1)

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