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IRCT20210728052005N1 IRCT 2021-09-06 Kerman University of Medical Sciences Comparative Investigating the effect of the Auricolotherapy and mindfulness-based stress reduction counseling on the nausea and vomiting of pregnancy in pregnant women Comparative Investigating the effect of the Auricolotherapy and mindfulness-based stress reduction counseling on the nausea and vomiting of pregnancy in pregnant women 2021-09-06 anticipated 159 Complete https://irct.ir/trial/57891 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Because people enter the study over time, the blocking method of blocking is used. Which is used from statistical software. Because the three groups are in this study, six blocks are used, Blinding description: In order to be blind, the statistical analyst would be unaware of which group the subjects belonged to. N/A nausea and vomiting of pregnancy. Intervention 1: Intervention group: Auriculotherapy .In the intervention group with Auriculotherapy, in addition to routine prenatal care and medication, for three consecutive weeks, every three to five days, Wakaria sids are attached to specific points (mouse, esophagus and master shoulder) of the mother's right ear. He is asked to press the labeled points five to six times a day for 60 seconds each time by applying pressure with his fingers. Intervention 2: Intervention group: Mindfulness-based stress reduction counseling. In the counseling intervention group with a Mindfulness-based stress reduction approach, individuals will undergo six two-hour face-to-face sessions for three weeks (two sessions per week). It is noteworthy that due to the prevalence of Covid-19 disease and the importance of maintaining the health of pregnant women, if the conditions are not favorable until the intervention, counseling sessions will be taught virtually using the Skyroom training platform. Intervention 3: Control group: Routine Pregnancy Care. In the control group, while receiving routine pregnancy care, considering the ethical aspect of the research, it will be possible to use anti-nausea pills up to three times a day. It is important to note that the list will be provided to the mother and she will be asked to write down the name of the drug and its dosage to report to the researcher if she is taking a pill or treatment to reduce nausea and vomiting. Yes - There is a plan to make this available What will be shared: After the study, some information such as information about gestational age, the severity of vomiting nausea can be shared. More definite decisions will be made with the tutor. When: Access period starts 6 months after the results are published To whom: After reading and printing the results, everyone will have access Conditions: The use of research results by mentioning the names of the facilitator and colleagues for use in future studies will be allowed. Where to obtain: zahrakashfi71@yahoo.com 00989124332581 zahra kashfi How to obtain: Up to one month after the request, the authorized information will be sent to the person Comments:
public zahra kashfi
No 5, Next to the Department of EducationLar, Shahr Jadid
Lar Iran (Islamic Republic of) 7431715544 +98 71 5224 5533 m.ghazanfarpour@kmu.ac.ir Kerman University of Medical Sciences scientific Dr.Masumeh Ghazanfarpour
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 m.ghazanfarpour@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Having the gestational age of the last 6-16 weeks on the first day of the last menstrual period. Mild or moderate vomiting nausea based on Rhodes index (score 8-24) Having complete physical and mental health (absence of gastrointestinal, heart or other underlying diseases) 4. Literacy to the extent of reading and writing 5. Having a single, normal, live, uncomplicated pregnancy and maintaining it until the end of the study 6. Women in the age range of 18 to 35 years 7. Willingness to participate in the study 8. Failure to use drugs that may be subjected to nausea and vomiting. Like: Metronidazole. 9. Mole pregnancy is ruled out by ultrasound. 18 years 35 years Female 1) Loss of pregnancy 2) Reluctance to continue to participate in the study 3) Hospitalization due to the transformation of the disease into a severe form of hypermesis gravidarum 4) Having any gastrointestinal disease or any disorder that leads to an abnormal increase in blood HCG levels ( Twins) 5) Using other methods to treat nausea and vomiting in pregnancy, except anti-nausea pills Treatment - Devices Treatment - Other Treatment - Other Intervention group: Auriculotherapy .In the intervention group with Auriculotherapy, in addition to routine prenatal care and medication, for three consecutive weeks, every three to five days, Wakaria sids are attached to specific points (mouse, esophagus and master shoulder) of the mother's right ear. He is asked to press the labeled points five to six times a day for 60 seconds each time by applying pressure with his fingers. Intervention group: Mindfulness-based stress reduction counseling. In the counseling intervention group with a Mindfulness-based stress reduction approach, individuals will undergo six two-hour face-to-face sessions for three weeks (two sessions per week). It is noteworthy that due to the prevalence of Covid-19 disease and the importance of maintaining the health of pregnant women, if the conditions are not favorable until the intervention, counseling sessions will be taught virtually using the Skyroom training platform. Control group: Routine Pregnancy Care. In the control group, while receiving routine pregnancy care, considering the ethical aspect of the research, it will be possible to use anti-nausea pills up to three times a day. It is important to note that the list will be provided to the mother and she will be asked to write down the name of the drug and its dosage to report to the researcher if she is taking a pill or treatment to reduce nausea and vomiting. Rhodes Nausea and Vomiting Questionnaire score. Timepoint: Rhodes questionnaire score was measured before the intervention, immediately after the intervention and two weeks after the intervention. Method of measurement: Rhodes Nausea and Vomiting Questionnaire. Kerman University of Medical Sciences Approved 2021-07-28 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences ,Medical University Campus ,Haft Bagh Highway ,Kerman ,Iran Kerman Kerman Iran (Islamic Republic of)