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OpenTrials
Completed

NCT Number: NCT07688629

Multidimensional Assessment of Nausea in Pregnancy

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Bilim Üniversitesi

Antalya, Muratpaşa, 00007, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fresh Quince Consumption

Other

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: P6 Acupressure Group, Control Group

P6 Acupressure

Other

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Prenatal Perceived Stress Scale Score

    Time frame: Baseline (Day 0) and End of Intervention (Day 7)

    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.

Other outcomes

  1. Quality of Life During Pregnancy Scale Score

    Time frame: aseline (Day 0) and End of Intervention (Day 7)

    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.

Sponsors and collaborators

Lead sponsor

Antalya Bilim University

Other

Registry information

Official study title

Multidimensional Assessment of Nausea in Pregnancy: A Three-Arm Randomized Controlled Study on the Effects of Quince and Acupressure

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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