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Effectiveness of regular desensitization intervention based on artistic creative simulation compared to behavioral model of ability, opportunity, motivation on the fear and pain of childbirth and the desire to have children later in first-time pregnant women

Protocol summary

Study aim
Effectiveness of regular desensitization intervention based on artistic creative simulation compared to behavioral model of ability, opportunity, motivation on the fear and pain of childbirth and the desire to have children later in first-time pregnant women
Design
A randomized clinical trial in parallel with the control group, random allocation by permutation block method and random concealment, sample size of 38 women in each intervention group (total sample size: 76 women), without blinding
Settings and conduct
Sampling is done by the available method based on suitability to participate in the study among women referring to Mortaz Hospital in Yazd. Women will be placed in two groups by randomization using permutation block method. People will be placed in two intervention groups and will receive online counseling for 8 consecutive weeks.
Participants/Inclusion and exclusion criteria
Healthy singleton pregnancy, gestational age 20-26 weeks, first pregnancy, fear of childbirth score equal to or greater than 66 Vijma, literacy, ability to speak Persian, willingness to participate in the study, having a smartphone. No entry. : Fetal/maternal disorders, severe life crises during the last 6 months, suffering from mental disorders based on the pregnancy file.
Intervention groups
.The first intervention group: The first group will receive regular desensitization based on artistic creative simulation in 8 consecutive weeks and 90-minute online counseling. The second intervention group: The second group (active control) will receive treatment of the behavioral model of ability, opportunity, and motivation in 8 consecutive weeks and 90-minute online counseling.
Main outcome variables
Luck / fear of childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240703062315N1
Registration date: 2024-08-11, 1403/05/21
Registration timing: prospective

Last update: 2024-08-11, 1403/05/21
Update count: 0
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
NEDA AHMADi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3726 7417
Email address
n.ahmadi@stu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of regular desensitization intervention based on artistic creative simulation compared to behavioral model of ability, opportunity, motivation on the fear and pain of childbirth and the desire to have children later in first-time pregnant women
Public title
Effectiveness of regular desensitization based on artistic creative simulation compared to behavioral model of ability, opportunity, motivation on fear and pain of childbirth and desire to have children later in first time pregnant women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy Singleton Pregnancy Gestational Age 20-26 Weeks First Pregnancy Having a Fear of Childbirth Score Equal to or More than 66 Vijma Literacy for Reading and Writing Ability to Speak Persian Willingness to Participate in the Study Having a Smartphone
Exclusion criteria:
Fetal/Maternal Disorders Severe life Crises During the last 6 Months Having Mental Disorders Based on the Pregnancy Record
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women referring to Mortaz Hospital in Yazd city are called based on the criteria of participating in the study and are sampled using the available method. Random allocation is obtained by permutation block method by considering blocks of size 4 using www.random.org/sequences software. Each woman is given a number between 1 and 76. Women are randomly assigned to two systematic desensitization groups based on artistic creative simulation or behavioral model of ability, opportunity, motivation (COMB) (38 women in each group). Concealment is done in random allocation so that neither the researcher nor the women know to which group each woman is assigned.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.SSU.REC.1403.024

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
080
ICD-10 code description
Single spontaneous delivery

Primary outcomes

1

Description
Luck / fear of childbirth
Timepoint
Baseline, completion of the intervention in the eighth week and follow-up 24 hours after delivery
Method of measurement
The luck/ٍExperience of Delivery to Wijma Questionnair

Secondary outcomes

1

Description
Pain
Timepoint
24 Hours after Delivery
Method of measurement
Visual Pain Scale

2

Description
Desire to Have Children
Timepoint
Baseline, completion of the intervention in the eighth week and follow-up 24 hours after delivery
Method of measurement
visual scale of desire to have children

Intervention groups

1

Description
The first intervention group: The first group received regular desensitization based on artistic creative simulation in 8 online and consecutive sessions, once a week for 90 minutes by the second researcher who completed the sexual disorders course and obtained the necessary certificate. It will be held under the supervision of the first researcher (reproductive health specialist and clinical psychologist) and the third researcher (reproductive health specialist) in the sky room. Skill training in fear reduction strategies, Jacobsen's relaxation technique, mental visualization of fearful situations, mindfulness and meditation, real exposure to simulation, preparation for real exposure in the format of educational video, PowerPoint, speech and question and answer will be implemented. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assignments related to the previous session will be reviewed by the first and second researcher to measure their improvement in each session. Women are asked to participate in counseling discussions and raise their questions. The second researcher will ask questions about the topics of the meeting for more people to participate in the meeting. To learn more, the relevant educational video will also be presented to them. At the end of each meeting, a summary of the important topics mentioned is presented and the questions of the people are answered, and the women are asked to do their homework until the next meeting.
Category
Behavior

2

Description
The second intervention group: the first intervention group: the second group, the behavioral model of ability, opportunity, and motivation in 8 consecutive online sessions, once a week for 90 minutes by the second researcher who completed the sexual disorders course and obtained the necessary certificate will be held under the supervision of the first researcher of the supervisor (reproductive health specialist and clinical psychologist) and the third researcher of the consultant professor (reproductive health specialist) will be held in the sky room. From giving birth, changing behavior based on a person's capacity or physical ability - the ability to learn and use the skills needed to change the behavior of fear, changing behavior based on the person's capacity or mental ability to give birth, empowering in cognitive reconstruction in the thought processes necessary for change behavior, changing behavior based on internal opportunities under the control of the individual, external opportunities by explaining the role of social norms in changing behavior, strengthening the motivation to change behavior with conscious decision-making, evaluating the process of change in the behavior of fear of childbirth, in the format of an educational video, PowerPoint, Lectures and questions and answers will be performed. At the beginning of each session, a summary of the contents of the previous sessions will be reviewed and the assignments related to the previous session will be reviewed by the first and second researchers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mortaz Hospital
Full name of responsible person
Hajeb Mortaz
Street address
Kashani Ave.
City
Yazd
Province
Yazd
Postal code
8915964953
Phone
+98 35 3824 1751
Email
Mortazhospital@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehei Abarghouaei
Street address
Bahnar Square, Central Organization of Shahid Sadougi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3733 3726
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh Farajkhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 5117 2438
Email
farajkhoda_t@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh FarajKhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 5117 2438
Email
farajkhoda_t@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tahmineh FarajKhoda
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 5117 2438
Email
farajkhoda_t@yahoo.com

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All personal Data of Study Participants can be Shared after De-identification.
When the data will become available and for how long
After Printing the Results.
To whom data/document is available
The Data will be Available to Researchers Working in Academic and Scientific Institutions, and People Working in Industry can Apply to Receive Them.
Under which criteria data/document could be used
Scientific Application
From where data/document is obtainable
farajkhoda_t@yahoo.com
What processes are involved for a request to access data/document
One Week after Receiving the Applicant's Email.
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