Protocol summary

Study aim
Determining the effect of Multimedia training on the Anxiety and Childbirth Experience of women with planned Cesarean section
Design
A controlled, parallel-group, unblinded, randomized clinical trial on 140 pregnant women. Blocks of four will be used for random allocation.
Settings and conduct
This study is a parallel randomized clinical trial with a control group on 140 pregnant women who between the 35th and 37th week of pregnancy refer to the perinatal clinic of Akbarabadi Hospital to receive pregnancy care and are scheduled to undergo a planned cesarean delivery with anesthesia. Spinal cord will be done. For women in the test group individually, a 4-6 minute educational video including all aspects of cesarean surgery will be shown in the consultation room of the clinic on the researcher's laptop. The control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being Iranian, women aged 18 to 45, ability to read and write Exclusion criteria: suspicion of congenital anomaly of the fetus, known mental disorder or history of taking anti-anxiety drugs and tranquilizers, history of infertility
Intervention groups
In the test group, a 4-6 minute individual training session will be shown on the researcher's laptop in the form of multimedia training based on educational video, including all aspects of cesarean section. Then this video is provided to the mother through messenger for unlimited viewing at home. There is no intervention for people in the control group.
Main outcome variables
Anxiety score from the Spielberger Anxiety Questionnaire ; Childbirth Experience score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N13
Registration date: 2023-03-01, 1401/12/10
Registration timing: prospective

Last update: 2023-03-01, 1401/12/10
Update count: 0
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Multimedia training on the Anxiety and Childbirth Experience of women with Planned Cesarean Section
Public title
The effect of educational film on pre-cesarean anxiety and childbirth experience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Women aged 18 to 45 Ability to read and write
Exclusion criteria:
Suspicion of Congenital Anomaly of the Fetus Known Mental Disorder or History of Taking Anti-anxiety Medications and Sedatives History of Infertility
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of people in the test and control group will be done using the quadruple block method (probabilistic type) using the site http://randomization.com/. Blocking is such that in this study, with 140 sample people, 70 people will be allocated to each group (the test group is considered to be A and the control group is considered to be B). Two defaults are considered, the size of each block is at least twice the number of groups (4 groups in each block) and the number of repetitions of groups is equal. According to the sample size of 140 people and the size of each block is 4, finally 35 blocks will be obtained. Then, using the site http://randomization.com/, the order of placement of the blocks and as a result the people of the test and control group is determined using the software. In order to hide the random allocation process, the names of the groups will be placed in opaque envelopes, and these envelopes will be numbered from 1 to 140 and arranged in a box. The researcher who conducts the sampling is unaware of the contents of the envelopes. The content of the envelopes will indicate the study groups, and after entering the study and completing the informed consent form, the participants will pick the first envelope in order of number and according to the content of the envelope, they will be placed in one of the two test and control groups.
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 Iran University of Medical Science
Street address
Next to Milad Tower, Hemet Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.IUMS.REC.1401.959

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Childbirth Experience
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Anxiety score in the state section of the Spielberger Anxiety Questionnaire
Timepoint
When entering the study, 30 minutes after the intervention in the perinatal clinic of the hospital, 30 minutes after being admitted to labor on the day of the operation and the evening of the day after the cesarean section.
Method of measurement
State section of the Spielberger Anxiety Questionnaire

2

Description
Childbirth Experience Score in the Questionnaire for Assessing the Childbirth Experience
Timepoint
The evening of the day after cesarean section
Method of measurement
ُShort version of Questionnaire for Assessing the Childbirth Experience

Secondary outcomes

1

Description
Overall satisfaction score for cesarean delivery
Timepoint
The evening of the day after cesarean section
Method of measurement
A general question about overall satisfaction with cesarean delivery in a demographic-midwifery researcher-made questionnaire in which the mother rates her satisfaction with anesthesia and cesarean delivery from 1 to 10.

Intervention groups

1

Description
Intervention group: In this research, the content of the intervention will be prepared in the form of a 4-6 minute educational film based on the principles of Mayer's multimedia education in the form of video, animation, images in MPEG-4 (MP4) format, and after entering the study of the educational film individually It will be displayed for the mother on the researcher's laptop in the consultation room of the Perinatal Clinic of Akbarabadi Hospital. This video includes trainings for familiarizing women undergoing planned cesarean section with all aspects of cesarean section as well as preparation for the operation: definition of cesarean section and its common indications, real images with explanations of the mother's admission and hospitalization process in the hospital and staff. The Medical staff that the mother will probably face, pre-operative medical care, operating room, mother's position for spinal anesthesia, animation to explain the anatomy of spinal anesthesia, animation of surgical incision and delivery of the baby, skin-to-skin contact images of mother and baby , the recovery room after surgery and the recovery process in the hospital. This video does not contain blood images and the dangers of spinal anesthesia. The educational content of this video is based on the latest health guide and service standard "Routine midwifery care, including before delivery, cesarean delivery and post-cesarean care" (Secretariat of the Strategic Council for Compilation of Health Guides, 1400) and also based on the latest trainings of American College of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynecologists and National Health Service of England.
Category
N/A

2

Description
Control group: There is no intervention for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi hospital
Full name of responsible person
Sara Sharafi
Street address
Bagh Ferdous station, not reaching the Molavi intersection, Molavi street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
+98 21 5560 8012
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Shahid Hemet highway, Region 2, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
In front of Khatamol anbiaa Hospital, Valiasr Ave., Rashid Yasemi Ave., Tehran town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
l.amirifarahani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
In front of Khatamol anbiaa Hospital, Rashid yasemi Ave., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
l.amirifarahani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
In front of Khatamol anbiaa Hospital, Rashid Yasemi Ave., Valiasr Ave., Tehran Town
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
+98 21 8820 1978
Email
l.amirifarahani@gmail.com

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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