- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544095
Guided Imagery for Nausea and Well-Being in Pregnant Women (GI-PREG)
The Effect of a Guided Imagery-Based Psychoeducational Intervention on Nausea, Vomiting, and Psychological Well-Being in Pregnant Women: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Muş, Turkey (Türkiye)
- Primary Health Care Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants in this group received a guided imagery-based psychoeducational program consisting of four face-to-face sessions supported by daily home-based practice.
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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.
|
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No Intervention: Control Group
Participants in this group received routine antenatal care without any additional intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nausea and Vomiting Severity
Time Frame: 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.
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Baseline and after completion of the 4-session intervention (approximately 2 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being
Time Frame: Baseline and after completion of the intervention (approximately 2 weeks)
|
Psychological well-being will be evaluated using a standardized psychological well-being scale.
Higher scores indicate better psychological well-being.
|
Baseline and after completion of the intervention (approximately 2 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tuba Enise Benli, Giresun University
- Study Chair: Yeşim Aksoy Derya, Inonu University
- Study Chair: Kader Atabey, Inonu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GI-NVP-2024-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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