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IRCT20250709066418N1 IRCT 2025-07-24 Kerman University of Medical Sciences comparison of the Effectiveness of Mindfulness-based Cognitive Therapy and Quince Fruit Leather Consumption in Nausea and Vomiting During Pregnancy in Pregnant Women comparison of the Effectiveness of Mindfulness-based Cognitive Therapy and Quince Fruit Leather Consumption in Nausea and Vomiting During Pregnancy 2025-08-16 anticipated 120 Complete https://irct.ir/trial/84665 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study is a clinical trial with a pre-test and post-test design with a control group. Random sampling will be conducted from pregnant women referring to obstetrics and gynecology clinics, and the Rhodes questionnaire will be used to measure the severity and frequency of nausea and vomiting before and after the intervention. Participants with mild to moderate nausea and vomiting will be included in the study based on the questionnaire and having the inclusion criteria, and will be divided into 3 groups of complementary medicine, counseling, and control using a block randomization method. The complementary medicine group (A), counseling group (B), and control group (C) are randomly generated using R version 4.4.1 software, with 44 blocks of 3 randomly generated. 3 Nausea and vomiting of pregnancy. Intervention 1: Intervention Group 1: Complementary Medicine Group: In this group, individuals consume 5 grams of fruit extract daily after each main meal for 4 weeks, and the questionnaire is completed again after the end of the intervention (4 weeks). Intervention 2: Intervention Group 2: Counseling Group: In this group, individuals will receive 8 mindfulness-based cognitive counseling sessions (each session 45 minutes) conducted twice a week. Intervention 3: Control Group 1: The control group in this group receives routine pregnancy care. Yes - There is a plan to make this available What will be shared: This research is titled (Comparison of the effectiveness of mindfulness-based cognitive therapy and the use of lavash in reducing nausea and vomiting during pregnancy). Participation in this research is completely voluntary. Participant information will be kept confidential. The results of the research will be published anonymously. When: Access period starts 6 months after results are published To whom: Your data will only be available to researchers working in academic and scientific institutions, or people working in industry can apply to receive it. Conditions: Allowed for academic studies Where to obtain: Fatemeh Ghaffari fa.ghafari97@gmail.com How to obtain: It takes about a week. Comments:
public Fatemeh Ghafari
No 51 ,Taleghani 21,Taleghani Street, Bam
Bam Iran (Islamic Republic of) 7661633157 +98 34 4431 7482 fa.ghafari97@gmail.com Kerman University of Medical Sciences scientific Fatemeh Ghafari
No 51 ,Taleghani 21,Taleghani Street, Bam
Bam Iran (Islamic Republic of) 7661633157 +98 34 4431 7482 fa.ghafari97@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) The first 12 weeks of pregnancy Mild to moderate nausea and vomiting Age between 18 and 40 years old Fetal health according to ultrasound Desire to be pregnant 18 years 40 years Female medical problems such as migraines, thyroid problems, infections, and psychiatric disorders smell problems tolerance to fruit mental health problems and adverse events in the six months prior to the study severe nausea and vomiting during pregnancy that requires fluid therapy and hospitalization pregnancy complications such as bleeding, threatened miscarriage history of chronic diseases, drug addiction, alcohol and cigarette use, drug allergies, or taking anti-nausea medications (such as vitamin B6 and metoclopramide) at least 48 hours before visiting the clinic. nausea and vomiting due to secondary causes such as peptic ulcer, hepatitis, pyelonephritis, pancreatitis, cholecystitis, appendicitis, gastroenteritis, urinary tract infection, central nervous system disorder, gastroesophageal reflux disease, hyperthyroidism, multiple pregnancy, ectopic pregnancy, molar pregnancy R11 Nausea and vomiting Treatment - Other Treatment - Other N/A Intervention Group 1: Complementary Medicine Group: In this group, individuals consume 5 grams of fruit extract daily after each main meal for 4 weeks, and the questionnaire is completed again after the end of the intervention (4 weeks). Intervention Group 2: Counseling Group: In this group, individuals will receive 8 mindfulness-based cognitive counseling sessions (each session 45 minutes) conducted twice a week. Control Group 1: The control group in this group receives routine pregnancy care. Nausea and vomiting of pregnancy: A persistent feeling of nausea and vomiting throughout the day experienced by a pregnant woman and assessed with a standard questionnaire. Timepoint: Measurement of nausea and vomiting at the beginning of the study and on day 28. Method of measurement: In this study, the standard Rhodes Index of Nausea and Vomiting questionnaire will be used to assess the severity and frequency of nausea and vomiting in pregnant women. Kerman University of Medical Sciences Approved 2025-06-21 Kerman University of Medical Sciences Kerman, Haft Bagh Alavi Square, Kerman University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)