Determining the effect of desensitization and reprocessing of eye movements on the fear of natural childbirth in primiparous women
Design
Clinical trial with control group, with parallel groups, blinding not done, sampling will be done in accessible form of 92 primiparous pregnant women. Then, people will be randomly assigned to the study group using quadruple blocks.
Settings and conduct
A sample of primiparous pregnant women with a gestational age of 38-39 weeks
Sampling place: health centers of Qazvin city
Sampling will be available.
We do not have blinding.
Procedure: 1- informed consent
2- Completing the demographic and Wijma-A questionnaires in both the participant sample and SUDS (only in the intervention group) (by face-to-face interview method)
3- Dividing research participants into two intervention and control groups by simple random block method
4- Intervention group: performing EMDR as a 90-minute session
Control group: distribution of pamphlets and regular training
5- Re-completion of the Wijma-A questionnaire by mothers after the end of the intervention
6- Follow-up: completion of Wijma-B, SUDS, and CityBiTS questionnaires by both groups in the first visit after delivery (third day after delivery) at the health center
Participants/Inclusion and exclusion criteria
Inclusion criteria: first pregnancy
Mothers who score higher than the cutoff in the Vijma questionnaire
Exclusion criteria: cesarean delivery with medical indication
Intervention groups
In the intervention group, the technique of desensitization and reprocessing of eye movements will be performed as a 90-minute session.
In the comparison group, pamphlets will be distributed and regular training will be provided.
Main outcome variables
Primary outcome: fear of childbirth
Secondary outcome: psychological birth trauma
General information
Reason for update
Acronym
EMDR
IRCT registration information
IRCT registration number:IRCT20240227061122N1
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Mahsa Dodangeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3552 7510
Email address
m.dodangeh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of eye movement desensitization and reprocessing (EMDR) on fear of normal vaginal delivery in primiparous women
Public title
Investigating the effect of eye movement desensitization and reprocessing (EMDR) on fear of normal vaginal delivery in primiparous women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having consent to enter the study
Having a gestational age of 38-39 weeks
Having a singleton pregnancy
The fetus is cephalic
First pregnancy
Obtaining a score higher than the cutoff in the Wijma questionnaire
Exclusion criteria:
The fetus has a known and diagnosed abnormality
Cesarean delivery due to medical indications
Under current psychological treatment
Having a history of previous psychological diseases
People with heart disease
People with epilepsy
Having a retinal tear or visual impairment
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method with balanced blocks with a block size of 4 will be used for random assignment due to the two groups of the study. In order to determine the allocation sequence using the 4 block method, online random allocation sequence generation software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used. In order to hide the sequence of allocation, the papers identifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the code 1 intervention.
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
Research Ethics Committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.QUMS.REC.1403.028
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth
Timepoint
In the 38-39 Week of pregnancy and in the First visit after delivery on the 3rd to 5th Day
Method of measurement
Wijma questionnaire
Secondary outcomes
1
Description
Psychological birth trauma
Timepoint
At the first postpartum visit on day 3 to 5 after delivery
Method of measurement
City Birth Trauma Scale
Intervention groups
1
Description
Intervention group: Desensitization and reprocessing of eye movements in a 90-minute session
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Qazvin
Full name of responsible person
Mahsa Dodangeh
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 9504
Email
dngmahsa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Peyman Namdar
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 9504
Email
dngmahsa@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mahsa Dodangeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Counseling in midwifery
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 9504
Email
m.dodangeh@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahsa Dodangeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Counseling in Midwifery
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 9504
Email
m.dodangeh@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahsa Dodangeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Counseling in Midwifery
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 9504
Email
m.dodangeh@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and health and treatment centers
Under which criteria data/document could be used
Only the above
From where data/document is obtainable
Mahsa Dodangeh
m.dodangeh@qums.ac.ir
What processes are involved for a request to access data/document