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The effectiveness of mindfulness-based pregnancy counseling on Prenatal Distress and marital satisfaction amongNulliparous pregnant women

Protocol summary

Summary
This research is a clinical trial with parallel control and control group. The population of the study is pregnant nulliparous women referring to Yazd medical centers, 30 eligible pregnant women are selected. Then, using random allocation software, the research samples were randomly divided into two groups of test and control in each group of 15 people. Pregnancy rate for women 20-30 weeks, Nullipar 2 - Ability to speak and understand the English language 3-Low-risk pregnancy 4-single-person 5-Having physical and mental health Exit criteria: 1. Having pregnancy complications 2- Having a history Severe psychiatric disorders and affliction with depression and depression 3. Having a history of infertility 4. Use of assisted reproductive techniques 5. Use of psychiatric drugs 6. Drug dependence and use of psychiatric drugs before or during pregnancy 7. Dependence on substance and use of psychiatric drugs by Spouse (According to the person) 8. No sudden onset of abnormal stress due to adverse events In the last 1 month, such as: the death of a spouse, divorce, separation and spouse's husband, imprisonment, the death of a close member of the family of the intervention group, participate in 8 sessions of mind-awareness, once a week for one and a half hours, organized by the researcher. . The control group does not receive any intervention other than routine care. Before the intervention and after the end of the session, one month after the intervention, the marital satisfaction and pregnancy agility questionnaires were completed by the samples in both groups. Aims: To determine and compare the mean score of marital satisfaction in the test group at the time before, immediately and one month after the intervention. 3- Determination and comparison of the mean score of the pregnancy concern in the test group before, immediately after and one month after the intervention. 4. Determination and comparison of the mean score. Marital satisfaction in the control group before, immediately and one month after the intervention. 5- Determination and comparison of the mean score of the pregnancy concern in the two groups of the test and control before, immediately after and one month afterwards. Variable parameters: Marital satisfaction with the Inrich marital satisfaction questionnaire is measured 2 - Concerns about pregnancy are measured by the pregnancy concern questionnaire. 3- Mindfulness counseling. It's about doing or not doing it Summary in 250 words:

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070534906N1
Registration date: 2017-09-20, 1396/06/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-20, 1396/06/29
Registrant information
Name
Fatemeh Shabani
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
shabanifatemeh69@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences, Yazd
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-08-26, 1396/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based pregnancy counseling on Prenatal Distress and marital satisfaction amongNulliparous pregnant women
Public title
effectiveness of mindfulness-based pregnancy counseling on Prenatal Distress and marital satisfaction
Purpose
Other
Inclusion/Exclusion criteria
Entry criterion: 1- Pregnant women 20-30 weeks, 2-Nullity Par 3 Low-risk pregnancies 4-Unicorns 5- Having physical and mental health 6-Ability to read and write 7-presenc e of spouse during pregnancy Exit criteria: Having pregnancy complications 2. Having a history of serious psychiatric disorders and having symptoms of depression and depression 3. Having a history of infertility 4. Using fertility methods 5. Using psychiatric drugs 6- Depending on drugs and taking medications before or during Pregnancy 7- Dependence on substance and use of psychiatric drugs by the spouse 8. According to the person's statement, sudden absence of abnormal stress due to adverse events of life in the last 1 month, such as: the death of the spouse, divorce, separation and wife's husband, imprisonment , The death of a close member of the family
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Sadoughi University of Medical Sciences Yazd
Street address
Yazd, Bahonar Square, Shahid Sadoughi Blvd.
City
Yazd
Postal code
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.SSU.REC.1396.78

Health conditions studied

1

Description of health condition studied
pregnancy distress and marital satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pregnancy distress
Timepoint
Before the intervention. At the end of the intervention, one month after the intervention
Method of measurement
pregnancy distress questionnaire

2

Description
maritall satisfaction
Timepoint
Before the intervention at the end of the intervention one month after the intervention
Method of measurement
Inrich Marital Satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the control group there is no consultation
Category
N/A

2

Description
Random samples of the intervention group, sessions for 8 sessions, each week for a period of 1.5 hours, will consist of 5 minutes of hiatus and voice, 30 minutes of the theory, 30-40 minutes of mindfulness training and 10 minutes of questions and answers. The content of the sessions, including greetings, the expression of natural and physical changes in pregnancy, including gastrointestinal changes, skin presentation, definition of mental consciousness, the expression of the relationship of stress and changes, and the practice of eating raisins, and the explanations of home activity in the first session, the second session of the homework review, genital mutilation, Body Surveillance and Home Health Indicators, Third Session: Homework, Counseling on Cardiovascular, Respiratory, and Neutrogens, Sitting Meditation and Home Living Exposure, Session Four: Reviewing homework, expressing sexual relationships, sleeping and having a rest and work, and consciousness breathing and home-living explanations, at the fifth session : Home homework, practice hat Yoga and counseling for emotional and psychological changes, anxiety, fear, depression, sixth session: homework, skeletal muscle, practice of thoughts of truth, explaining home activity, seventh session: recording pleasing and unhealthy notes, explaining the process of labor and the eighth session of using learning and aggregation Past is
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Shahid-Ja'fari community of Rahmat Abad
Full name of responsible person
Ms. Jalali, Midwifery expert
Street address
Yazd Rahmat Abad Shahid Dashti blvd
City
yazd

2

Recruitment center
Name of recruitment center
Health center of Musa bin Ja'far Azadshahr
Full name of responsible person
Ms. Khazalpour, Midwifery expert
Street address
Yazd Azadshahr Telecommunication Alley
City
YAZD

3

Recruitment center
Name of recruitment center
Farabi Community Health Center
Full name of responsible person
Miss Bacon Midwifery
Street address
Yazd Blvd. Dashti Alley Shahidan Dashti
City
YAZD

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
دانشگاه علوم پزشکی شهید صدوقی
Street address
Yazd, Bahonar Square, Shahid Sadoughi Blvd.
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd Nursing Midwifery Faculty
Full name of responsible person
fatemeh shabani
Position
Student
Other areas of specialty/work
Street address
The street of Thamesar Fallahi Boulevard Boulevard
City
Yazd
Postal code
Phone
+353 8241751
Fax
Email
maryam_dafei@yahoo.comshabani fatemeh89@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd Nursing Midwifery Faculty
Full name of responsible person
Maryam Dafei
Position
Doctor of Reproductive Health
Other areas of specialty/work
Street address
Yazd, Taysar Avenue, Bouly Alley
City
Yazd
Postal code
Phone
+353 8241751
Fax
Email
maryam_dafei@yahoo.comshabanifatemeh89@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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