Investigating the effectiveness of mindfulness-based intervention on the feeling of decreased fetal movements in the third trimester of pregnancy outcomes and number of referrals in Niknafs maternity hospital in Rafsanjan in 2023.
Determining the effect of psychological intervention based on mother's mindfulness on the feeling of reduced fetal movements in the third trimester of pregnancy, pregnancy outcomes and the number of referrals to Nik Nafs maternity hospital in Rafsanjan in 2023
Design
The current study is a semi-experimental study of an intervention type with a pre-test, post-test and control group design. Sampling is pilot and the number of samples is 30 people. The samples will be divided into two control and intervention groups as a block of four.
Settings and conduct
Pregnant women in the intervention group will undergo individual psychological counseling based on mindfulness for 45 minutes. Audio and video files are sent. A pregnant woman can ask the consultant questions related to counseling and movements of her fetus until the end of her pregnancy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age less than 35 years old; absence of oligohydraminos and polyhydraminos; no smoking and any opioids; absence of anterior placenta; absence of SGA fetus; singleton pregnancy. Exclusion criteria: not attending more than two sessions; participating in other counseling sessions.
Intervention groups
Pregnant women who feel a decrease in fetal movements between 28-30 weeks of gestation, after consulting and confirming the health of the fetus, immediately on the bed, undergo individual psychological counseling based on mindfulness for 45 minutes, and then once every three days and in 5 counseling sessions from It is carried out remotely (telephone and virtual space). Pregnant women can also ask their questions through communication channels. The control group will not receive any counseling except pregnancy routine.
Main outcome variables
Number of referrals; pregnancy outcome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230826059260N1
Registration date:2023-09-09, 1402/06/18
Registration timing:registered_while_recruiting
Last update:2023-09-09, 1402/06/18
Update count:0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Faezeh Ghasemirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3426 7649
Email address
f.ghasemirad74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-02, 1402/06/11
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of mindfulness-based intervention on the feeling of decreased fetal movements in the third trimester of pregnancy outcomes and number of referrals in Niknafs maternity hospital in Rafsanjan in 2023.
Public title
The effect of psychological intervention based on mother's mindfulness on the feeling of decreased fetal movements in the third trimester of pregnancy, pregnancy outcomes and the number of referrals
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 35 years old
Absence of oligohydraminosis and polyhydraminosis
Absence of smoking and any opioids
Absence of anterior placenta
Absence of SGA fetus
Singleton pregnancy
Exclusion criteria:
Failure to attend more than two sessions
Participation in other counseling sessions
Age
To 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.KMU.REC.1402.122
Health conditions studied
1
Description of health condition studied
Abnormal pregnancy
ICD-10 code
O36.9
ICD-10 code description
Maternal care for fetal problem, unspecified
Primary outcomes
1
Description
The number of visits to the mother due to the feeling of decreased fetal movements
Timepoint
Throughout pregnancy
Method of measurement
Self-made questionnaire
Secondary outcomes
1
Description
Pregnancy outcomes include: Apgar <7 in the first 5 minutes of birth, Apgar <4 in the first 5 minutes of birth, birth weight less than 10%, birth weight <2 SD, NICU admission, fetal death (stillbirth), premature delivery (less than 37 weeks), age Pregnancy at birth > 6+41, spontaneous onset of labor, induction of labor, cesarean section
Timepoint
Postpartum
Method of measurement
Self-made questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: The research population is pregnant women with decreased fetal movements in the gestational age range of 28-30 weeks who have visited Nik Nafs maternity hospital for the first time. After obtaining informed consent from the pregnant parents and if they meet the entry criteria, the pregnant mother will enter the study with the doctor's confirmation that there is no problem and the health of the fetus. The samples will be divided into two control and intervention groups. Pregnant women in the intervention group are immediately placed on the bed, undergoing individual psychological counseling based on mindfulness for 45 minutes. After discharge, once every three days and in 5 times, remote counseling is done, which includes three components: 1) a short phone call of 5 minutes 2) immediately after the phone call, audio files And a video is sent to women as a part of the consultation via WhatsApp, Telegram or Skype. 3) A pregnant woman can ask the counselor questions related to counseling and fetal movements in phone consultations and in between through WhatsApp, Telegram or Skype until the end of her pregnancy.
Category
Other
2
Description
Control group:Control group: This group does not receive any counseling and only prenatal care is performed and is evaluated through a self-made questionnaire: fetal movements, pregnancy outcome and the number of referrals.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Niknafs maternity hospital in Rafsanjan
Full name of responsible person
zahrahashemi
Street address
Shohada St
City
Rafsanjan
Province
Kerman
Postal code
7715633863
Phone
+98 34 3425 9040
Email
f.ghasemirad74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abedin Iranpour
Street address
Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
a.iranpour@kmu.ac.ir
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
Dr. Firozeh Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
F_mirzaee@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Firozeh Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
F_mirzaee@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firuzeh Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
F_miraee@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the information related to the main consequences is possible to share.
When the data will become available and for how long
The access period starts six months after the announcement of the results
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
To investigate additional research and other parameters
From where data/document is obtainable
via email F_mirzaee@gmail.com
What processes are involved for a request to access data/document
The request should be sent via e-mail, and after checking and approval, it will be sent within a period of one month