Nausea and Vomiting in PregnancyGI-PREGNCT07544095
Guided Imagery for Nausea and Well-Being in Pregnant Women
A study testing Guided Imagery-Based Psychoeducation in people with Nausea and Vomiting in Pregnancy, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting in Pregnancy
- What is being tested?
- Guided Imagery-Based Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Guided Imagery-Based Psychoeducational Intervention on Nausea, Vomiting, and Psychological Well-Being in Pregnant Women: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Nausea and Vomiting in Pregnancy
- Being tested
- Guided Imagery-Based Psychoeducation
- Keywords
- Guided Imagery, Psychoeducation, Pregnancy, Nausea and Vomiting, Psychological Well-Being, Non-pharmacological Intervention
- Medical subject headings
- Nausea, Vomiting, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery-Based PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided Imagery-Based Psychoeducation |
| Control Group | No intervention | Participants in this group received routine antenatal care without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after completion of the 4-session intervention (approximately 2 weeks)
Secondary outcomes (1)
Psychological Well-Being
Psychological well-being will be evaluated using a standardized psychological well-being scale. Higher scores indicate better psychological well-being.
Measured: Baseline and after completion of the intervention (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start26 Apr 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting in PregnancyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Enise BENLI, Inonu University
- Investigators
- Tuba Enise Benli, Study chair, Giresun UniversityYeşim Aksoy Derya, Study chair, Inonu UniversityKader Atabey, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544095
- Sponsor's protocol ID
- GI-NVP-2024-01
- Acronym
- GI-PREG
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Guided Imagery-Based Psychoeducational Intervention on Nausea, Vomiting, and Psychological Well-Being in Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07544095
- Acronym / sponsor ID
- GI-PREG / GI-NVP-2024-01
- Conditions
- Nausea and Vomiting in Pregnancy
- Keywords
- Guided Imagery, Psychoeducation, Pregnancy, Nausea and Vomiting, Psychological Well-Being, Non-pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Guided Imagery-Based PsychoeducationParticipants in this group received a guided imagery-based psychoeducational program consisting of four face-to-face sessions supported by daily home-based practice. |
| Control Group | No intervention | –Participants in this group received routine antenatal care without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery-Based PsychoeducationA 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. | Behavioural | Experimental Group |
Primary outcome
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.
1 secondary outcome
Psychological Well-Being
Time frame: Baseline and after completion of the intervention (approximately 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuba Enise Benli study chair
Giresun University
Yeşim Aksoy Derya study chair
Inonu University
Kader Atabey study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery-Based Psychoeducation in people with Nausea and Vomiting in Pregnancy, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea and Vomiting Severity (time frame: Baseline and after completion of the 4-session intervention (approximately 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.