跳至主要内容
临床试验/NCT06688604
NCT06688604已完成不适用

The Effect of Infant Attachment Barrier on Maternal Sadness and Adaptation: a Randomized Controlled Trial

Kahramanmaras Sutcu Imam University2 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2023年1月1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
351
试验地点
2
主要终点
Maternal Sadness and Adaptation

研究概览

简要总结

This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.

详细描述

This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation. The research is a randomized controlled experimental study. The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99). In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth. No intervention was made with the mothers in the control group. Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.

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
Single (Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Had given birth at Mardin Training and Research Hospital
  • No physical and/or mental health issues
  • No infectious diseases transmitted through contact
  • Agreed to participate in the study
  • Able to speak Turkish and/or does not have communication issues
  • Single live birth with the baby
  • Mothers who gave birth vaginally or via spinal anesthesia and had skin-to-skin contact with their baby within the first 5 minutes postpartum

排除标准

  • Foreign nationals, immigrants, or those with communication issues
  • Individuals with any physical and/or mental health problems
  • Those with infectious diseases transmitted through contact
  • Individuals who did not agree to participate in the study
  • Mothers whose baby was stillborn (ex) after birth
  • Mothers whose babies were receiving treatment in the intensive care unit
  • Those who do not wish to provide a phone number
  • Women who gave birth vaginally or via spinal anesthesia and do not wish to establish contact with their baby
  • Mothers who gave birth to twins or more babies

结局指标

主要结局

Maternal Sadness and Adaptation

时间窗: 9 month

The development, reliability and validity study of the scale was conducted by Küçük and Cesur (Küçük, E. (2022) Postpartum maternity blues assesment scale: Improvement, validity and reliability study) (Thesis No. 727989) \[Master's thesis, Sivas Cumhuriyet University\] National Thesis Center of the Council of Higher Education.) in 2022. The scale included questions prepared to determine the psychological changes that occur in the mother in the postpartum period and what kind of problems these changes may create in the mother. The scale was created as a 5-point Likert type to be answered by the participants. The scale contains 23 items. The items in the scale were applied as '1- Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5- Strongly Agree'. A high score on the scale indicates that the symptoms of maternal sadness in the postpartum period are high. A scale consisting of three sub-dimensions with 23 items (First Factor 'Maternal self-care dimension', second factor 'Infant care di

Postpartum Self-Assessment Scale

时间窗: nine mounth

It was decided to be developed by Lederman and Weingarten in 1981 to evaluate the adaptation process of women in the postpartum period to motherhood. It is a 4-point Likert-type scale with 82 items. There are 7 subscales that evaluate the Postpartum Self-Assessment Scale. Each subscale contains 10 to 13 items. 39 of the items in the scale are reverse-biased. The numbers of the reverse-biased items in the scale are as follows; 1, 2, 4, 6, 9, 10, 14, 15,16, 22, 29, 30, 32, 33, 36, 38, 40, 41, 42, 43, 44, 46, 47, 49, 51, 53, 54, 59, 61, 62, 67, 69, 71, 73, 77, 78, 79, 81, 82. The scale is measured with a 4-point assessment. Postpartum adjustment is evaluated based on the results of scores ranging from "1" to "4" (4: "Describes very much," 3: "Partially describes," 2: "Somewhat describes," 1: Does not describe at all"). Scoring for reverse items is done in the opposite way. The lowest possible score for the entire scale is 82, and the highest is 328. Low scores indicate that the adaptatio

Mother-Infant Contact Barrier Scale

时间窗: nine mounth

Development of the Scale and Examination of Its Psychometric Properties was conducted by Kömürcü Akik and Durak Batıgün (Akik, B. K., \& Batıgün, A. D. (2020). Mother-Infant Contact Barrier Scale (ABTEÖ): Development and Psychometric Properties. Current Approaches in Psychiatry/Psikiyatride Guncel Yaklasimlar, 12.) in 2020. It was planned to be developed to measure possible contact barriers that may be experienced between the mother and the baby, such as difficulties in adaptation between the mother and the baby after birth and negative experiences related to birth, based on the mother's report. A total of 38-item question pool form was created by the authors. After the preliminary preparations, a 37-item form with Likert-type scores from 1 to 5 ("1 = Doesn't Apply to Me at All", "2 = Doesn't Apply to Me", "3 = Undecided", "4 = Applies to Me Somewhat", and "5 = Applies to Me Completely") was created. The 37-item version of the scale was applied to the participants. As a result of the v

次要结局

未报告次要终点

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysel Bulez

Principal Investigator

Kahramanmaras Sutcu Imam University

研究点 (2)

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