NCT07544095

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 9, 2026

Last Update Submit

April 19, 2026

Conditions

Keywords

Guided ImageryPsychoeducationPregnancyNausea and VomitingPsychological Well-BeingNon-pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Nausea and Vomiting Severity

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

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

Secondary Outcomes (1)

  • Psychological Well-Being

    Baseline and after completion of the intervention (approximately 2 weeks)

Study Arms (2)

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.

Behavioral: Guided Imagery-Based Psychoeducation

Control Group

NO INTERVENTION

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

Interventions

A structured psychoeducational program based on guided imagery techniques, consisting of four face-to-face sessions aimed at reducing nausea and vomiting symptoms and improving psychological well-being. Participants were instructed to practice guided imagery daily at home using standardized audio recordings.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care Center

Muş, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NauseaVomitingPsychological Well-Being

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Tuba Enise Benli

    Giresun University

    STUDY CHAIR
  • Yeşim Aksoy Derya

    Inonu University

    STUDY CHAIR
  • Kader Atabey

    Inonu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation to reduce assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the intervention group or the control group. The intervention group received a guided imagery-based psychoeducational program, while the control group received routine antenatal care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 22, 2026

Study Start

April 26, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations