Comparison of the Effect of Mindfulness-Based Counseling and Training of Effective Communication Skills with the Spouse on Nausea and Vomiting in Pregnant Women
Determining the effect of mindfulness-based counseling and teaching effective communication skills with the spouse on nausea and vomiting in pregnant women
Design
Random clinical trial with control group, with parallel groups, without the possibility of blindness, sample size: 120. The clinical trial includes: one control group and two intervention groups.
For randomization, a random table is prepared using On-line software.
Settings and conduct
The study is performed on pregnant clients 8-22 weeks of Amir Al-Momenin Hospital in Semnan. The working method in intervention group (a) ARCT intervention (b) is effective communication training in 4 sessions of 90 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Mild and higher nausea according to Rhodes Pregnancy Nausea and Vomiting Questionnaire, gestational age from 8 to 22 weeks of gestation
Exclusion criteria: pregnancy loss, pregnant woman's dissatisfaction with continued cooperation, concomitant physical illness leading to nausea and vomiting, or history of psychiatric disorder
Intervention groups
.(Control group): In this group, routine medical care is performed and virtual education is given to prevent and reduce nausea and vomiting.
(Intervention group A): In this group, in addition to the usual medical care, 4 sessions of mind-based counseling are given.
(Intervention group b): In this group, in addition to the usual medical care, 4 sessions of effective communication skills training are given to pregnant mothers in this group.
Main outcome variables
Nausea and vomiting in pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201214049706N1
Registration date:2021-02-01, 1399/11/13
Registration timing:prospective
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Elaheh Azadbash
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7612
Email address
elaheh.azadbash@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Mindfulness-Based Counseling and Training of Effective Communication Skills with the Spouse on Nausea and Vomiting in Pregnant Women
Public title
Comparison of the Effect of Mindfulness-Based Counseling and Training of Effective Communication Skills with the Spouse on Nausea and Vomiting in Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mild and higher nausea according to the Rhodes Pregnancy Nausea and Vomiting Questionnaire of pregnancy
Gestational age from 8 to 22 weeks
Single pregnancy
The mother has the ability to use a smartphone or Labtab, etc. that can make Internet calls
Willingness to participate in the project
Exclusion criteria:
- Loss of pregnancy
Dissatisfaction of the pregnant woman to continue cooperation
Simultaneous physical illness that leads to nausea and vomiting such as acute pyelonephritis and any gastrointestinal disease leading to nausea and vomiting
History of hospitalization due to neurological problems
Maternal physical problems that prevent the mother from participating in the 90-minute class
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence is prepared by the statistical consultant professor and using Online software, a random table for 150 people is provided to the researcher.
Given that we have three groups of comparisons, the type of randomization is based on 6 random blocks. The number of blocks is 25 6 blocks that will be prepared using the Sequence table software.
The allocation of participants is done using concealment with the method of closed envelopes. In this method, the sequence table designed in the previous section is used.
Due to the fact that the type of intervention is known, there is no possibility of blindness.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Unit: 6, floor 4,No. 34, Helal ahmar 7 Ave.,
City
Semnan
Province
Semnan
Postal code
3514815341
Approval date
2020-12-08, 1399/09/18
Ethics committee reference number
IR.SHMU.REC.1399.131
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting in Pregnant Women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea and Vomiting in Pregnant Women
Timepoint
In the fourth intervention session
Method of measurement
Nausea and vomiting questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group (A): In this study, 4 sessions of counseling based on mindfulness are 90 minutesMindfulness skills training: Session 1: Part 1: Communicating with clients and obtaining information from them; Automatic Thought Identification Introducing Model Self-Regulation: Raisin Exercise; Introduction Focus on focus with practice in the session. Assignment: Meditation with tape (continued during the experimental period). Part II: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Homework: Mini-meditation before mealsScratch 2: Assisting clients in recognizing these thoughts, and teaching the use of thought recording, teaching cognitive distortion to clients. Brief meditation (after each session); Practice mindful eating (cheese and sweet crackers); Conceptual and mental eating; bodyscan. Assignment: Eat 1 snack meal (the rest in the remaining period by increasing the number of grains / snacks) Session 2: Part 1: Diaphragm breathing training and sleep hygiene. Exercise with the wrong adjustment (sweet, high-fat food). Assignment: Mini-meditation before the second meal: training to adjust the mind and label the mind for thoughts, feelings, behaviors. Increase recognition of the personal consequences of chronic anxiety, conduct low-cost analysis of chronic anxiety of clients. Forgiveness meditation. Homework: Eat all meals and snacks carefullySession 3: Part 1: Visual nausea or vomiting; Sitting Yoga Wise Tactics Walking Meditation ÷ Assignment: Participate in Satisfaction and Enjoyment, Enjoy Mineral Foods and Eat / Chopped Foods Part II :: Generating the Hierarchy of Others, Imagination, Facing Acceptance, Exposing Inside Exposure Through Increase Planned Partnership Session 4: Part One: Generating the Hierarchy of Others, Imaginations, Facing Acceptance, Exposing Internal Exposure through Increased Planned Participation Creating a Hierarchy Concerns About Bodybuilding Concerns About Relationships Imagination with Accepting Exposure In vivo by increasing participation Participation in subsequent planning of pregnancy and childbirthPart 2: Review the progress of browsing and techniques in a way that is most useful for review. Other activities Other meetings
Category
Lifestyle
2
Description
Intervention group (B): 4 90-minute sessions of training communication skills training with spouse..Effective communication training: Intervention group (a): In this study, 4 sessions of counseling based on mindfulness are 90 minutes. Session 1: Part 1: Introducing the group and members to each other, familiarity with the working method and structure of the sessions, examining expectations from the program Part II: Increasing Self-Awareness, Emphasizing the Importance of Self-Confidence Session Two: Part One: Identifying Couples 'Beliefs and Expectations about Happiness Part Two: Demonstrating the Impact of Beliefs on Individuals' Feelings and BehaviorSession 3: Part One: Listening Skills Training Part Two: Speaking Skills Training Session Four: Part One: Assessing Conflict Resolution Skills, Training and Practicing Conflict Resolution Skills Part Two: Summarizing and Answering Questions and Performing Post-Test
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital, Semnan
Full name of responsible person
Elaheh Azadbash
Street address
Unit 6, floor 4, No. 34, Helal ahmar 7
City
Semnan
Province
Semnan
Postal code
3514815341
Phone
+98 23 3343 7612
Fax
+98 23 3343 6066
Email
elaheh.azadbash@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Elaheh Azadbash
Street address
Unit 6,Floor 4 ,No.34, Helal Ahmar 7 Ave.
City
Shahroud
Province
Semnan
Postal code
3514815341
Phone
+98 23 3343 7612
Fax
+98 23 3343 6066
Email
elaheh.azadbash@gmail.com
Web page address
Grant name
Dr MohamadHasan Emamian
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
1
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
Shahroud University of Medical Sciences
Full name of responsible person
Elaheh Azadbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Helal Ahmar 7
City
Semnan
Province
Semnan
Postal code
3514815341
Phone
+98 23 3343 7612
Fax
+98 23 3343 6066
Email
elaheh.zadbash@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Elaheh Azadbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Helal Ahmar 7
City
Semnan
Province
Semnan
Postal code
3514815341
Phone
+98 23 3343 7612
Fax
+98 23 3343 6066
Email
elaheh.azadbash@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Elaheh Azadbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Helal Ahmar 7
City
Semnan
Province
Semnan
Postal code
3514815341
Phone
+98 23 3343 7612
Fax
+98 23 3343 6066
Email
elaheh.azadbash@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Score of nausea and vomiting in pregnant women before and after mindfulness counseling and effective communication training sessions and the content of mindfulness counseling and effective communication training sessions
When the data will become available and for how long
Since the publication of the article, it is possible to access valid sites
To whom data/document is available
researchers
Under which criteria data/document could be used
With the consent of all members of the research team, the data can be transferred
From where data/document is obtainable
Email the free goddess elaheh.azadbash@gmail.com
What processes are involved for a request to access data/document
By requesting an email to the goddess Azadbash elaheh.azadbash@gmail.com