Study of the effect of self-compassion training on the anxiety of primiparous women in the first stage of labor with control of the patient companion: Clinical trial with factorial design
Study of the effect of self-compassion training on the anxiety of primiparous women in the first stage of labor with control of the patient companion: Clinical trial with factorial design
Design
This study is a non-blinded clinical trial. The study population will be all primiparous women referring to Motazadi hospital of Kermanshah.88 eligible women will be selected conveniently and randomly assigned to 4 groups.
Settings and conduct
This study that will be conducted in Motazadi hospital of Kermanshah is non-blinded. At the beginning of the study, Spielberger Anxiety Inventory will be provided for them. At the end of the study, the anxiety questionnaire will be provided for the study participants again .
Participants/Inclusion and exclusion criteria
Inclusion criteria: nulliparous women; Pregnancy age 20-29 weeks at the start of self-compassion training; Pregnancy age 42-38 weeks at delivery
Exclusion criteria: Use of psychotropic drugs or neurology drugs;History of infertility;Fetal anomaly diagnosis
Intervention groups
The first intervention group will receive 8 self-compassion training sessions of 90 min ( Based on Gilbert's compassion-focused therapy book )and researcher companionship with the pregnant mother during labor for 8 weeks. The second intervention group will receive 8 self-compassion training sessions of 90 min ( Based on Gilbert's compassion-focused therapy book) and no researcher accompanying the pregnant mother during labor. The third intervention group will not receive compassion training, but there is a researcher accompanying the pregnant mother during labor for 8 weeks. The control group will not receive compassion training and there is no researcher accompanying the pregnant mother during labor for 8 weeks.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200227046627N1
Registration date:2020-03-19, 1398/12/29
Registration timing:prospective
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Sahar Omidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3725 6816
Email address
omidisahar1375@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of self-compassion training on the anxiety of primiparous women in the first stage of labor with control of the patient companion: Clinical trial with factorial design
Public title
Study of the effect of self-compassion training on the anxiety of primiparous women in the first stage of labor with control of the patient companion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nulliparous women
Pregnancy age 20-29 weeks at the start of self-compassion training
Pregnancy age 42-38 weeks at delivery
Exclusion criteria:
Use of psychotropic or neurology drugs
History of infertility
Fetal anomaly diagnosis
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, participants are divided into four groups of 22 . Those with a code number 1 to 22 will be in group A, those with numbers 23 to 44 in group B, numbers 45 to 66 in group C and numbers 67 to 88 in group D.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-02-03, 1395/11/15
Ethics committee reference number
ir.kums.rec.1398.1151
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Beginning and end of study
Method of measurement
Using Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 8 self-compassion training session of 90 min ( Based on Gilbert's compassion-focused therapy book )and researcher companionship with the pregnant mother during labor for 8 weeks
Category
Lifestyle
2
Description
The second intervention group will receive 8 self-compassion training session of 90 min ( Based on Gilbert's compassion-focused therapy book) and no researcher accompanying the pregnant mother during labor
Category
Lifestyle
3
Description
The third intervention group will not receive compassion training, but there is a researcher accompanying the pregnant mother during labor for 8 weeks
Category
Other
4
Description
The control group will not receive compassion training and there is no researcher accompanying the pregnant mother during labor for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motazadi Hospital
Full name of responsible person
Sahar Omidi
Street address
Ferdowsi Square, Motazadi Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
omidisahar1375@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sahar Omidi
Position
Master of Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Counseling in Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
omidisahar1375@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marziyeh Kaboudi
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
fkaboudi@kums.ac.ir:
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sahar Omidi
Position
Master of Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Counseling in Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
omidisahar1375@gmail.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail