A comparative study of the effectiveness of two counseling methods based on acceptance and commitment (ACT) and motivational telemedicine methods on secondary tokophobia in single-child women
Investigating the effect of comparing two counseling methods based on commitment and acceptance and telemedicine motivational counseling on secondary tokophobia in single-child women.
Design
The clinical trial has three groups, including two intervention groups and one control group, which is not blinded in this study. In this study, the block randomization method of six blocks will be used to randomly assign people to the groups under study.
Settings and conduct
The place of study is the health care centers of Mashhad University of Medical Sciences. After extracting the samples from the Sina system, they are divided into three groups according to the entry criteria, and they receive consultations through the "Mom Up" application.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inclusion criteria include women with a child at least two years old with secondary tokophobia, living in Iran, no previous history of psychological problems, literacy, no prohibition in terms of pregnancy such as hysterectomy, High-risk pregnancies or secondary infertility, etc., is having a smart phone. Exclusion criteria: unwillingness to continue cooperation in the plan, absence of more than two counseling sessions, receiving counseling or related information from another source other than the intervention program.
Intervention groups
randomly assigning the qualified people are divided into three groups. A counseling group based on commitment and acceptance will receive 4-6 weekly sessions and the motivational counseling group will receive four weekly sessions. compare the effect of two methods of counseling based on commitment and acceptance and motivational counseling based on telemedicine on secondary tokophobia. It will be done in single-child women.
Main outcome variables
Secondary tokophobia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240207060923N1
Registration date:2024-05-18, 1403/02/29
Registration timing:registered_while_recruiting
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
maryam Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3766 7404
Email address
ramezanim4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of two counseling methods based on acceptance and commitment (ACT) and motivational telemedicine methods on secondary tokophobia in single-child women
Public title
Comparison of ACT and motivational counseling methods on tokophobia of single-child women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women with a child at least two years old with secondary tokophobia
living in Iran
no previous history of psychological problems
reading and writing literacy
having a smart phone
Exclusion criteria:
Unwillingness to cooperation in the project
prohibition of pregnancy in terms of high-risk pregnancies.
Previous history of psychological problems
Lack of reading and writing
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
In the current research, the block randomization method will be used to randomly assign people to the groups under study. The list of block randomization, division of groups and allocation of people will be done using blocks of six and specifying the sequence inside each block and in sealed envelopes. According to the estimated sample size and using the specialized website for the production of randomization process related to clinical trial studies (Sealed envelope), the allocation of people to each group and its order will be determined based on the pattern of blocks of six. The type of allocation will be placed in sealed envelopes separately and hidden, and the number and order will be specified on each envelope. The website https://www.sealedenvelope.com is a dedicated site for generating random sequences of various types.This site is designed in such a way that there is no limit on the number of groups for random assignment. Blocked randomization aims to ensure that exactly equal numbers of participants enter the intervention and control groups at consecutive but equal time intervals. Then, for each person, the corresponding envelope that will be inside the blocks, is selected and based on the assigned group, which includes a specific code and is unpredictable and guesswork, the person is completely randomly placed in group A, B, or C. will take The generation of random blocks was done by the design methodology consultant through the above website and 17 random blocks of six with the sequence inside each block along with a unique random code containing three characters were set for each of the 102 people so that in the implementation stage, random allocation take
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 Mashhad Faculty of Medical Sciences
Street address
Zhanbaz Zhanbaz Blvd. 7 Sofard 13
City
mashhad
Province
Razavi Khorasan
Postal code
9197736542
Approval date
2024-02-06, 1402/11/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.001
Health conditions studied
1
Description of health condition studied
Secondary tokophobia (fear of pregnancy again)
ICD-10 code
F53.8
ICD-10 code description
Other mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Secondary tokophobia score
Timepoint
before the study and one month and 8-10 weeks after the intervention
Method of measurement
Questionnaire of secondary tokophobia, depression, anxiety and post-traumatic stress
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Counseling based on commitment and acceptance is one of the new counseling techniques that is provided for 4-6 weekly sessions in the intervention group. In this method, the first two face-to-face sessions and the subsequent online sessions receive counseling.
Category
Rehabilitation
2
Description
The second intervention group: Motivational counseling is one of the counseling techniques that receive four weekly sessions, two initial face-to-face sessions and subsequent online sessions.
Category
Rehabilitation
3
Description
Control group: In this group, routine care and consultations that currently exist are performed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad imamat health center
Full name of responsible person
Maryam Ramezani
Street address
7 Janbaz Street
City
Mshhad
Province
Razavi Khorasan
Postal code
9197736542
Phone
+98 51 3766 7404
Email
Ramezanim4012@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9197736542
Phone
+98 51 3766 7404
Email
Ramezanim4012@mums.ac.ir
Grant name
Mashhad University of Medical Sciences
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
Sedigheh Abdollahpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kharazmi Faculty of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9197736542
Phone
+98 51 3766 7404
Email
abdollahpourts2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Ramezani
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
7 Janbaz St
City
Mashhad
Province
Razavi Khorasan
Postal code
9197736542
Phone
+98 51 3766 7404
Email
Ramezanim4012@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sedigheh Abdollahpour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Science Street, Ferdowsi University of Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9197736542
Phone
+98 51 3766 7404
Email
abdollahpourts2@yahoo.com
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
Yes - There is 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
Comparison of the mean score of secondary tokophobia at the beginning and end of the study by ACT counseling method in two intervention and control groups
Comparison of the mean score of secondary tokophobia at the beginning and end of the study by motivational counseling method in two intervention and control groups
Comparison of the mean score of secondary tokophobia at the beginning and end of the study in the two intervention groups of motivational counseling and ACT counseling
When the data will become available and for how long
Access period starts 6 months after final printing
To whom data/document is available
It will be available for people who are researchers working in academic and scientific institutions and also people who are working in industry can apply for them.
Under which criteria data/document could be used
In situations where the researcher needs to cite the study
From where data/document is obtainable
Maryam Ramezani
ramezanim4012@mums.ac.ir
What processes are involved for a request to access data/document
The applicant can receive the documents within 48 hours by emailing the researcher