Comparative Investigating the effect of the Auricolotherapy and mindfulness-based stress reduction counseling on the nausea and vomiting of pregnancy in pregnant women
Determining and comparing the effect of Auriculotherapy and mindfulness-based stress reduction counseling on pregnancy nausea and vomiting in pregnant women
Design
Clinical trial has control group, with parallel groups, one-blind, randomized, phase 2 on 159 patients. Used to randomization of R software.
Settings and conduct
After receiving a research license, the researcher learns the skills before starting the uricolotherapy, and after obtaining a degree and approval of the jurisdiction by the relevant specialist, it will begin to pregnant women referring to the clinics of the city of Lar. in the field of consultation and coordination Astadmshavr after offering them counseling sessions start Shvd.mtalh clinical trial is randomized. For blindness, the statistical advisor is unaware of what individuals belong.
Participants/Inclusion and exclusion criteria
1. Having a gestational age of 6-16 weeks on the first day of the last menstrual period
2. Mild or moderate vomiting nausea based on Rhodes index (score 8-24)
3. Dealing with 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. Are you taking nausea and taking medications that may have side effects? Such as: metronidazole
9. Mole pregnancy is ruled out by ultrasound
Intervention groups
Three groups of 53 people are subjected to 15% drop in each group.
Control group - Intervention with Auriculotherapy,
Advisory intervention group with a stress-based stress approach
Main outcome variables
Reduce nausea and vomiting of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210728052005N1
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Zahra Kashfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 5533
Email address
zahrakashfi71@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Investigating the effect of the Auricolotherapy and mindfulness-based stress reduction counseling on the nausea and vomiting of pregnancy in pregnant women
Public title
Comparative Investigating the effect of the Auricolotherapy and mindfulness-based stress reduction counseling on the nausea and vomiting of pregnancy in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
In order to be blind, the statistical analyst would be unaware of which group the subjects belonged to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences ,Medical University Campus ,Haft Bagh Highway ,Kerman ,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-07-28, 1400/05/06
Ethics committee reference number
IR.KMU.REC.1400.237
Health conditions studied
1
Description of health condition studied
nausea and vomiting of pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Other
3
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Saheb alzaman Clinic
Full name of responsible person
Dr.Rezaee
Street address
Shahr ghadim ,Modares Square
City
Lar
Province
Fars
Postal code
7431715544
Phone
+98 71 5224 5533
Email
zahrakashfi71@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Fax
+98 34 3132 5829
Email
m.ghazanfarpour@kmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
zahra kashfi
Position
Master Student Of Counseling In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 5, Next to the Department of EducationLar, Shahr Jadid
City
Lar
Province
Fars
Postal code
7431715544
Phone
+98 71 5224 5533
Email
m.ghazanfarpour@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Masumeh Ghazanfarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
m.ghazanfarpour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
zahra Kashfi
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 5 .Next to the Department of Education .Shahr jadid .Lar
City
Lar
Province
Fars
Postal code
7431715544
Phone
+98 71 5224 5533
Email
m.ghazanfarpour@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
After reading and printing the results, everyone will have access
Under which criteria data/document could be used
The use of research results by mentioning the names of the facilitator and colleagues for use in future studies will be allowed.