- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688629
Multidimensional Assessment of Nausea in Pregnancy
Multidimensional Assessment of Nausea in Pregnancy: A Three-Arm Randomized Controlled Study on the Effects of Quince and Acupressure
Nausea and vomiting during pregnancy are common, affecting a large proportion of women (approximately 50-75%). This symptom usually begins in the first trimester and is mostly mild or moderate; however, in some cases, it impairs quality of life, reduces nutritional intake, leads to emotional distress, and, rarely, can develop into serious conditions such as hyperemesis gravidarum.
Pharmacological approaches can be effective, especially in severe cases; however, the fear of drug-related side effects among many pregnant women and physicians is a limiting factor in drug use. Therefore, the role of complementary and non-pharmacological approaches is gaining importance, particularly in pregnant women with mild to moderate nausea. On the other hand, acupressure (especially P6/Neiguan point stimulation) is a non-invasive complementary practice whose effect in reducing nausea and vomiting during pregnancy is debated. Meta-analyses report that acupressure can significantly reduce nausea symptoms in pregnancy. However, there is a need for clearer results in the literature due to methodological differences, variability in effect sizes, and low quality scores of some studies.
Quince (Cydonia oblonga), on the other hand, is not as researched an option as acupressure in the literature for managing nausea in pregnancy. In a study comparing quince syrup with vitamin B6 in the literature, quince was found to be a more effective application than vitamin B6. Quince may theoretically have the potential to reduce nausea due to its positive effects on gastrointestinal motility, its stomach-soothing properties, and its antioxidant compound content. However, randomized controlled trials proving this effect in terms of safety and efficacy during pregnancy are limited.
Nausea during pregnancy not only causes physical discomfort but also reduces quality of life, negatively affects self-care behaviors, and can increase perceived stress levels. Therefore, nausea management should aim not only at symptom reduction but also at supporting the holistic well-being of the pregnant woman. In this context, psychosocial indicators such as the Quality of Life in Pregnancy Scale, Self-Care Ability Scale, and Perceived Prenatal Stress Scale are important in revealing not only the physiological but also the psychological and behavioral effects of complementary practices.
Therefore, examining the effects of quince and acupressure applications on not only the severity of nausea but also on quality of life, self-care ability, and perceived stress levels in pregnant women with mild to moderate nausea will fill the gap in the literature and contribute to the identification of evidence-based, safe, and applicable complementary approaches in the management of nausea in pregnancy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Muratpaşa
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Antalya, Muratpaşa, Turkey (Türkiye), 00007
- Antalya Bilim Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women aged 18-35 years
- Gestational age between 6 and 14 weeks
- Singleton pregnancy
- Mild to moderate nausea and vomiting of pregnancy as assessed by the PUQE-24 scale
- Nausea and vomiting not requiring hospitalization or pharmacological treatment
- No known gastrointestinal disease
- Ability to understand study procedures and provide informed consent
- Willingness to participate and comply with study procedures
Exclusion Criteria:
- Severe nausea and vomiting requiring hospitalization
- Nausea and vomiting requiring pharmacological treatment
- Multiple pregnancy
- Threatened miscarriage
- Known gastrointestinal disease
- Withdrawal of consent at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Quince Group
Participants will consume approximately 25-42 g of fresh quince daily for 7 consecutive days in addition to receiving standard dietary recommendations for nausea and vomiting during pregnancy.
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Participants assigned to the quince group will consume approximately 25-42 g of fresh quince daily for 7 consecutive days.
The amount was determined based on phenolic content equivalence to quince syrup used in a previous randomized clinical trial.
Participants will receive standardized instructions regarding preparation, portion size, timing of consumption, and daily recording of intake.
All participants will also receive standard dietary recommendations for the management of nausea and vomiting during pregnancy.
Other Names:
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Experimental: P6 Acupressure Group
Participants will perform P6 (Neiguan) acupressure on both wrists three times daily for 5 minutes per session over 7 consecutive days in addition to receiving standard dietary recommendations.
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Participants assigned to the acupressure group will perform P6 (Neiguan) acupressure on both wrists three times daily for 5 minutes per session over a 7-day intervention period.
The P6 point is located on the inner aspect of the wrist, approximately three finger widths proximal to the wrist crease between the tendons of the palmaris longus and flexor carpi radialis muscles.
Participants will receive face-to-face training and demonstration by the research team.
Standard dietary recommendations for nausea and vomiting during pregnancy will also be provided.
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No Intervention: Control Group
Participants will receive standard dietary recommendations for nausea and vomiting during pregnancy and routine prenatal care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Score
Time Frame: Baseline (Day 0), Daily During Intervention (Days 1-7), and Follow-up (Days 8-14)
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Assessment of the severity of nausea and vomiting during pregnancy using the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) scale. Higher scores indicate more severe symptoms. PUQE-24 Assessment Scale: Lowest Score (0 - 3): Mild nausea and vomiting. Moderate Score (4 - 6): Moderate nausea and vomiting. Highest Score (7 - 15): Severe nausea and vomiting. |
Baseline (Day 0), Daily During Intervention (Days 1-7), and Follow-up (Days 8-14)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prenatal Perceived Stress Scale Score
Time Frame: Baseline (Day 0) and End of Intervention (Day 7)
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Assessment of perceived prenatal stress using the Prenatal Perceived Stress Scale. Higher scores indicate greater perceived stress. PUQE-24 Assessment Scale: Lowest Score (0 - 3): Mild nausea and vomiting. Moderate Score (4 - 6): Moderate nausea and vomiting. Highest Score (7 - 15): Severe nausea and vomiting. |
Baseline (Day 0) and End of Intervention (Day 7)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Life During Pregnancy Scale Score
Time Frame: aseline (Day 0) and End of Intervention (Day 7)
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Assessment of pregnancy-related quality of life using the Quality of Life During Pregnancy Scale. PUQE-24 Assessment Scale: Lowest Score (0 - 3): Mild nausea and vomiting. Moderate Score (4 - 6): Moderate nausea and vomiting. Highest Score (7 - 15): Severe nausea and vomiting. |
aseline (Day 0) and End of Intervention (Day 7)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1. Matthews A, Haas DM, O'Mathúna DP, Dowswell T. Interventions for nausea and vomiting in early pregnancy. Cochrane Database of Systematic Reviews. 2015;(9):CD007575. 2. Herrell HE. Nausea and vomiting of pregnancy. American Family Physician. 2014;89(12):965-970. 3. Jafari-Dehkordi E, Hashem-Dabaghian F, Aliasl F, et al. Comparison of quince with vitamin B6 for treatment of nausea and vomiting in pregnancy: a randomized clinical trial. Journal of Obstetrics and Gynaecology. 2017;37(8):1048-1052. 4. Gong J, Gu D, Wang H, Zhang F, Shen W, Yan H, Xie J. Effect of acupressure in nausea and vomiting treatment during pregnancy: A meta-analysis. Explore. 2024;20(1):17-26. 5. Soltani H, Forouhari S. Effect of P6 acupressure on nausea and vomiting in pregnancy: A systematic review and meta-analysis. Journal of Integrative Medicine. 2023;21(2):121-131.
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Signs and Symptoms, Digestive
- Pregnancy Complications
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Vomiting
- Morning Sickness
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- ABU-00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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