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临床试验/NCT06537570
NCT06537570已完成不适用

The Effect of Guided Imagery Practice on Psychosocial Health and Fear of Childbirth in Primiparous Pregnant Women: A Randomized Controlled Trial

University of Gaziantep2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年7月20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
Wijma Birth Expectation/ Experience Scale-A Version

研究概览

简要总结

Physical changes that occur during pregnancy, transition to parenthood and taking on new responsibilities cause burden, anxiety and stress in women and negatively affect psychosocial health. One of the conditions that negatively affect psychosocial health during pregnancy is the fear of childbirth. One of the current methods used in the management of the pregnancy process is guided imagery.It is known that guided imagery practice reduces stress and anxiety in pregnant women, increases well-being and is beneficial to their daily lives, contributes positively to mother-baby attachment, and reduces pain in childbirth.

详细描述

2.1.Study Design

This research was conducted as a randomized controlled experimental study to determine the effect of guided imagery on the psychosocial health and fear of childbirth of primiparous pregnant women. The study was conducted between July 20, 2022 and January 20, 2023 with pregnant women admitted to the obstetrics and gynecology outpatient clinic of XXX Hospital in Gaziantep, Turkey. The hospital where the study was conducted has 7 gynecology outpatient clinics and 1 pregnancy school.

2.2.Sample

The population of the research consisted of all primiparous pregnant women in the 24-28th week of pregnancy. The sample size was calculated using the G Power program. Previous studies were examined and the expected confidence intervals of the "Psychosocial Health Assessment Scale in Pregnancy (PPHAS)" were determined and the confidence interval was calculated as 80 primiparous with α = 0.05, test power (1-β) 0.95, and effect size d= 1.14. Minimum number of pregnant women required in the two groups was found to be 40 for the expectation that there would be a significant difference between the experimental group and the control group in terms of psychosocial health. The sample of the study consisted of 80 pregnant women, 40 in the experimental group and 40 in the control group. The study reached 91 participants, but 11 participants were excluded because they refused to participate in the study (Figure 1). Medcalc version 18.11.3 was used for the randomization list in assigning pregnant women to groups.

Study inclusion criteria of volunteers

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 (Participant)

入排标准

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

入选标准

  • Volunteer to participate in the study
  • Having no condition to prevent communication
  • Age 18-35
  • No vision and hearing problems
  • At the 24th-28th week of pregnancy
  • With a single fetus
  • Primiparous pregnancies

排除标准

  • Illiterate
  • Before the 24th week of pregnancy
  • Having multiple pregnancies
  • Multiparous
  • With psychopathological disease
  • Pregnant women with medical or pregnancy complications

结局指标

主要结局

Wijma Birth Expectation/ Experience Scale-A Version

时间窗: 12 weeks

0 is expressed as "completely" and 5 is expressed as "none". While the minimum score on the scale is 0, the maximum score is 165.

Psychosocial Health Assessment Scale in Pregnancy

时间窗: 12 weeks

Psychosocial Health Assessment Scale in Pregnancy. The minimum score that can be obtained from the scale is 46 and the maximum score is 230.

次要结局

  • Psychosocial Health Assessment Scale in Pregnancy sub-dimensions(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ece Kaplan

Asst. Prof.

University of Gaziantep

研究点 (2)

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