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临床试验/NCT07263750
NCT07263750招募中不适用

The Effect of Haptonomy Application for Primiparous Pregnant Women and Their Partners on Prenatal Attachment and Fear of Childbirth: A Randomized Controlled Study

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年3月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
144
试验地点
1
主要终点
Prenatal Attachment Inventory (PAI)

研究概览

简要总结

This study was planned to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.

详细描述

Aim: This study was designed to evaluate the effect of haptonomy practice for primiparous pregnant women and their partners on prenatal attachment and fear of childbirth.

Methods: This randomized controlled experimental study will include primiparous pregnant women and their partners (36 couples in the experimental group and 36 couples in the control group) who apply to the childbirth education class of a public hospital in Turkey and are between 24-26 weeks of gestation.

The experimental group will receive haptonomy education in the childbirth class. Afterwards, a video-based haptonomy program will be delivered via e-mail or WhatsApp. Couples will be asked to perform haptonomy exercises once a week for 40 minutes over five weeks. No intervention will be applied to the control group.

Data will be collected before the intervention and at the end of the fifth week using the Personal Information Form, Prenatal Attachment Inventory (PAI), Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), Paternal-Fetal Attachment Scale (PFAS), and Fathers' Fear of Childbirth Scale (FFOC).

Data analysis will include frequency and percentage distributions, chi-square test, t-test, Mann-Whitney U test, repeated measures analysis, two-way ANOVA, Friedman test, and Cohen's d test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • At least a primary school graduate
  • Between the 24th and 26th weeks of pregnancy
  • According to calculations made by ultrasound based on the last menstrual period or, for pregnant women who do not know their last menstrual period, between the 24th and 26th weeks of pregnancy
  • Primiparous
  • No history of abortion/curettage
  • Planned/desired pregnancy
  • Desired baby gender
  • Living with spouse
  • Attended pregnancy classes
  • Able to use technology such as computers and mobile phones to watch videos
  • No barriers to understanding questions and responding
  • No previous training on fear of childbirth or prenatal bonding
  • Not having previously received education on haptonomy or practised haptonomy
  • Not undergoing infertility treatment
  • Being between the ages of 19 and 35

排除标准

  • • Be at least 26 weeks pregnant
  • Live separately from spouse
  • Have an unplanned/unwanted pregnancy
  • Not want the baby to be of a specific gender
  • Not use technology
  • Be a high-risk pregnancy
  • Have previously received training on fear of childbirth and prenatal bonding
  • Having previously received training in haptonomy and practised haptonomy
  • Deciding to discontinue haptonomy practice after the study began and/or giving birth prematurely before completing the practice sessions

研究组 & 干预措施

experimental group

Experimental

Haptonomy training will be provided to the experimental group within the childbirth class. Afterwards, the video-based haptonomy program will be sent via e-mail or WhatsApp. Couples will be asked to practice haptonomy exercises for five weeks, one 40-minute session per week.

干预措施: Haptonomy (Behavioral)

control group

No Intervention

Standard of care Group The control group will not receive any treatment

结局指标

主要结局

Prenatal Attachment Inventory (PAI)

时间窗: Baseline

The PAI is a validated, explain thoughts, feelings, and situations experienced by woman during pregnancy and to determine the level of attachment to infant in prenatal period. Each item is of a four-point Likert type, with a score between 1 and 4. A minimum score of 21 and a maximum score of 84 can be obtained from the scale. Increase in the score obtained by pregnant indicates that level of attachment also increases.

Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)

时间窗: Baseline

The W-DEQ-A is a validated,to determine the level of birth fear experienced by pregnant women.Answers in the scale are numbered from 0 to 5 and are in a six-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 165.

Paternal-Fetal Attachment Scale (PFAS)

时间窗: Baseline

PFAS is a validated scale used to determine the level of paternal-fetal attachment. The responses are rated on a four-point Likert scale ranging from 1 to 4. The minimum possible total score is 23, and the maximum is 92.

Fathers' Fear of Childbirth Scale (FFOC)

时间窗: Baseline

The FFOC is a validated instrument used to determine fathers' level of fear related to childbirth. The responses are rated on a five-point Likert scale ranging from 1 to 5. The minimum possible total score is 17, and the maximum is 85.

次要结局

  • Paternal-Fetal Attachment Scale (PFAS)(Week 5)
  • Prenatal Attachment Inventory (PAI)(Week 5)
  • Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A)(Week 5)
  • Fathers' Fear of Childbirth Scale (FFOC)(Week 5)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel DİLMEN

Lecturer

Nigde Omer Halisdemir University

研究点 (1)

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