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临床试验/NCT07544095
NCT07544095已完成不适用

The Effect of a Guided Imagery-Based Psychoeducational Intervention on Nausea, Vomiting, and Psychological Well-Being in Pregnant Women: A Randomized Controlled Trial

Inonu University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Nausea and Vomiting Severity

研究概览

简要总结

This study aims to evaluate the effect of a guided imagery-based psychoeducational intervention on nausea and vomiting severity and psychological well-being in pregnant women. The intervention includes structured psychoeducation and guided imagery sessions designed to promote relaxation, enhance symptom management, and improve overall well-being. Pregnant women in the first trimester experiencing nausea and vomiting were randomly assigned to either the intervention group or the control group. The intervention group received a four-session guided imagery-based psychoeducation program supported by home-based audio practice, while the control group received routine antenatal care. Outcomes were assessed before and after the intervention using standardized measurement tools.

详细描述

This randomized controlled study was conducted to determine the effect of a guided imagery-based psychoeducational intervention on nausea and vomiting severity and psychological well-being in pregnant women. The study included pregnant women in their first trimester who were experiencing nausea and vomiting and met the inclusion criteria.

Participants were randomly assigned to either the intervention group or the control group. The intervention group received a structured psychoeducational program based on guided imagery techniques. The program consisted of four face-to-face sessions, each lasting approximately 20-25 minutes. The first session included information about the relationship between nausea, vomiting, and psychological processes, as well as an introduction to guided imagery. Participants were also provided with an audio recording to support daily home practice. In subsequent sessions, guided imagery techniques were applied to reduce nausea symptoms, enhance relaxation, and promote psychological well-being. Participants were encouraged to practice the technique regularly and especially during episodes of nausea.

The control group received routine antenatal care without any additional intervention. Data were collected from both groups before and after the intervention using standardized instruments, including the Pregnancy Unique Quantification of Emesis (PUQE) scale and a psychological well-being scale.

The study was retrospectively registered. Ethical approval was obtained from the Inonu University Health Sciences Scientific Research Ethics Committee (Approval No: 2024/5747).

研究设计

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

盲法说明

Outcome assessors were blinded to group allocation to reduce assessment bias.

入排标准

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

入选标准

  • Being 18 years of age or older
  • Being in the first trimester of pregnancy (≤14 weeks)
  • Experiencing nausea and vomiting during pregnancy
  • Having a singleton pregnancy
  • Being able to read and understand Turkish
  • Voluntarily agreeing to participate in the study

排除标准

  • Having a high-risk pregnancy (e.g., preeclampsia, gestational diabetes, placenta previa)
  • Diagnosis of hyperemesis gravidarum
  • Having a diagnosed psychiatric disorder or receiving psychiatric treatment
  • Having a condition that may prevent participation in guided imagery (e.g., hearing or cognitive impairment)
  • Previous experience with guided imagery or similar psychological interventions

研究组 & 干预措施

Experimental Group

Experimental

Participants in this group received a guided imagery-based psychoeducational program consisting of four face-to-face sessions supported by daily home-based practice.

干预措施: Guided Imagery-Based Psychoeducation (Behavioral)

Control Group

No Intervention

Participants in this group received routine antenatal care without any additional intervention.

结局指标

主要结局

Nausea and Vomiting Severity

时间窗: Baseline and after completion of the 4-session intervention (approximately 2 weeks)

Nausea and vomiting severity will be assessed using the Pregnancy Unique Quantification of Emesis (PUQE) scale. Higher scores indicate greater severity of symptoms.

次要结局

  • Psychological Well-Being(Baseline and after completion of the intervention (approximately 2 weeks))

研究者

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

Tuba Enise BENLI

Principal Investigator

Inonu University

研究点 (1)

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