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临床试验/NCT06508554
NCT06508554已完成不适用

The Door to the Womb at Birth: Haptonomy

Trakya University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Birth Memory and Recall Scale

研究概览

简要总结

Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor.

Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Married and pregnant women,
  • ≥ 18 years old,
  • Able to read, write and understand Turkish,
  • Living in the city center where the study is conducted,
  • Does not have any physical or psychological health problems for herself or her baby,
  • Having a spontaneous pregnancy at 28.< gestational weeks,
  • Those who have not received haptonomy application before,
  • Pregnant women who agreed to participate in the study were included.

排除标准

  • Those with psychological and chronic health problems,
  • Pregnant women who did not agree to participate in the study were not included.

结局指标

主要结局

Birth Memory and Recall Scale

时间窗: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

This scale developed by Foley et al. in 2014, was adapted into Turkish by Topkara and Çağan in 2021. The scale is a 7-point Likert type. The scale, which consists of a total of 21 items, has six sub-dimensions. Its sub-dimensions are "Emotional Memory", "Ambivalent Emotional Memory", "Centeredness of Memory", "Coherence and Reliving", "Sensory Memory" and "Involuntary Remembering". The highest score that can be obtained from the scale is 147 and the lowest score is 6. High scores from the "Emotional Memory" sub-dimension indicate that the mother's negative emotions about the birth experience are more intense, high scores from the "Ambivalent Emotional Memory" sub-dimension indicate that the mother has more ambivalent emotions, and high scores from the "Centeredness of Memory" sub-dimension indicate that the mother has more ambivalent emotions.

Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version

时间窗: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

This scale was adapted from Wijma et al. Developed by. The purpose of the scale is to evaluate women's fear of birth during their own birth experiences in the postpartum period. Turkish validity and reliability study was conducted by Uçar and Beji. The scale consists of 33 items. Each item is a 6-point Likert type with scores ranging from 1 to 6, with 1 being "completely" and 6 being "not at all". While the minimum score on the scale is 33, the maximum score is 198. High scores indicate that women have a high fear of childbirth. Negatively loaded questions in the scale (2, 3, 6, 7, 8, 11, 12,15, 19, 20, 24, 25, 27, 31) are calculated by reversing them in the opposite direction to ensure consistency in measurement.

Self-Efficacy Scale in Labor

时间窗: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.

Self-Efficacy Scale in Labor - Short Version' was developed by Ip et al. to measure self-efficacy levels in labor. The Turkish validity and reliability study of the scale was conducted by Ersoy (2011). The scale consists of two sub-dimensions: outcome expectation and competence expectation, and there are 16 questions in each sub-dimension. The lowest score to be obtained from the sub-dimensions of the scale is 16 and the highest score is 160. A high score from each subscale indicates that pregnant women have high expectations of adequacy and outcome regarding labor. Responses on a Likert-type scale are scored from 1 to 10.

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

Burcu KUCUKKAYA

Assist. Prof

Trakya University

研究点 (2)

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The Door to the Womb at Birth: Haptonomy | 临床试验