Protocol summary

Study aim
Comparison of the mean stress and anxiety in two groups of pregnant women with and without spousal support during amniocentesis
Design
A clinical trial with a control group, in parallel groups, one-way blind, randomized is performed on 90 patients. Randomization is done using double blocks.
Settings and conduct
Two perinatology centers in Mashhad in Imam Reza and Umm Al-Banin hospitals In the intervention group, a briefing session (support for pregnant women) is held for husbands before amniocentesis. Maternal stress and anxiety are measured in three stages in the control and intervention groups, and correction is performed for statistical data analysts.
Participants/Inclusion and exclusion criteria
Minimum literacy Gestational age 15 to 18 weeks Willingness to participate in the study The desire for his wife to be present at his bedside during amniocentesis No entry: Couple dissatisfaction History of mental illness Reproductive assistance methods
Intervention groups
For pregnant women's wives, a face-to-face briefing session will be held for 45 to 60 minutes, two to seven days before the amniocentesis, which will provide information on the need and method of amniocentesis, its complications, its consequences for stress, and Anxiety in pregnant women and the effect of their presence and support on their husbands in reducing their stress and anxiety levels. During this process, after amniocentesis care, Men are asked to be with their wives and provide the necessary support for them. for the Control group, routine care will be performed.
Main outcome variables
Anxiety and stress levels of amniocentesis pregnant women included in the study before the intervention, before and after amniocentesis will be completed with standard Spielberger Anxiety Inventory, DASS-21 Anxiety and Stress and Depression Inventory and self-made questionnaire of spouse support by research units. became.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220423054626N1
Registration date: 2023-03-02, 1401/12/11
Registration timing: prospective

Last update: 2023-03-02, 1401/12/11
Update count: 0
Registration date
2023-03-02, 1401/12/11
Registrant information
Name
Fatemeh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 472 9909
Email address
salehif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-12, 1401/12/21
Expected recruitment end date
2023-04-10, 1402/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of husband’s support on maternal anxiety and stress of pregnant women undergoing the amniocentesis
Public title
The efficacy of husband’s support on maternal anxiety and stress of pregnant women undergoing the amniocentesis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age: 15-18 weeks Ability of reading and writing couples Satisfaction for participation in the project candidate of amniocentesis Score 20-59 from the Spielberger Anxiety Questionnaire on the Manifest's Anxiety Scale (mild to moderate) Obtain a stress score greater than 14 and less than 26 from the DASS-21 questionnaire
Exclusion criteria:
History of infertility and Pregnancy with assisted reproductive techniques History of amniocentesis Taking psychiatric drugs History of mental illness and hospitalization due to mental health problems for at least the last 6 months
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Randomized blocking based on PASS_11 software with 4 blocks Random unit: All pregnant mothers who meet the study entry criteria. Tools: Blocked closed packets based on software Concealment: The sealed packets of the people that have been prepared using the PASS_11 software are selected at the same time as the mother enters the study. Based on the assigned number in each group, the people are assigned to two intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those who evaluate the outcome
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ebne sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.095

Health conditions studied

1

Description of health condition studied
Amniocentesis
ICD-10 code
Z36.0
ICD-10 code description
Encounter for antenatal screening for chromosomal anomalies

Primary outcomes

1

Description
Pregnant mother anxiety level
Timepoint
At the beginning of the study and before and after amniocentesis
Method of measurement
Spielberger Anxiety Questionnaire - DOS21 Questionnaire - Spouse Supportive Behavior Checklist

2

Description
Pregnant mother stress level
Timepoint
At the beginning of the study and before and after amniocentesis
Method of measurement
Anxiety and Depression Stress Questionnaire DASS 21

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the wives of pregnant women in the intervention group, a face-to-face briefing session will be held for 45 to 60 minutes, two to seven days before the amniocentesis. Stress and anxiety of pregnant women and the effect of their presence and support on their husbands in reducing their stress and anxiety level from the time of knowing about the procedure, during the procedure, post-amniocentesis care, how to respond and They will be given time to go to the centers to receive the result. They are also asked to be present with and support their spouses during the amniocentesis. This support will include both physical and psychological parts. In the physical support section, the man takes the pregnant mother's hand with one hand and caresses her with the other hand, facing the mother's face so that she does not see the amniocentesis. In the psychological support section, the man establishes eye contact with the pregnant mother and reminds her of a pleasant memory in order to take his wife's mind away from the sampling area, and the researcher controls and records all these cases through a checklist. In both groups, the amniocentesis will be the same. To do the amniocentesis, the person lies on a test bed and to minimize the risk of infection, the abdomen is disinfected using alcohol. An ultrasound doctor uses a sonography to determine the exact location of the bladder to minimize the risk of harm to the fetus. This may take up to 20 minutes. The doctor then inserts a long, thin needle into the bladder through the abdominal wall and, under ultrasound guidance, closely monitors the process. The doctor removes the required amount of amniotic fluid with a syringe and then removes the needle. Getting fluid may take a few minutes, but it usually takes less than 30 seconds. It is worth mentioning that Spielberg Anxiety Questionnaire, Depression, Anxiety and Stress Questionnaire DASS-21 (Stress Section) by pregnant women in both groups were completed by self-report before and after amniocentesis. The spouse will be present with the pregnant mother while filling out the questionnaire.Also, all these things are done in the presence of the researcher.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Mahin Tafazoli
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
Tafazolim@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy Research
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Salehi
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Salehif951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
MahinTafazoli
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9 913791319
Phone
+98 51 3859 1511
Email
tafazolim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Salehi
Position
Master Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
salehif951@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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