Determining effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women
Design
Clinical trail with control group,with parallel group,no blinding,randomized,on 110 patients,to randomize from the website https://www.sealedenvelope.com/simple-randomiser/v1/lists and the 4-block method is used
Settings and conduct
Location of the maternity ward of Hakim Hospital in Neishabour,
For mothers of the intervention group ,in addition to routine care , the researcher will conduct a Solution Focused Brief Counseling based counseling session individually for 45 to 60 minutes.
For mothers of the control group, only routine care is provided.
The anxiety test is completed by the Spilberger Questionnaire after counseling for both groups in two steps, in dilatation of 5 and 8 and 10 centimeter of cervical.
Participants/Inclusion and exclusion criteria
Pregnancy age 37 to 41 weeks
Fetal health in the first trimester ultrasound examination
The pregnant mother has no special medical or midwifery problems
Wanted pregnancy
No entry condition:
History of psychotherapy or mental illness
Addiction to cigarettes or drugs and alcohol
Having a history of recurrent miscarriage and infertility
Taking anti anxiety and anti depressant drugs
The onset of labor pains
Intervention groups
Intervention group: provide solution focused brief counseling before the onset of labor pains in nulliparous women in addition to receiving routine in the delivery block
control group: receiving routine in the delivery block
Main outcome variables
Anxiety level in nulliparous women؛ intensity of labor pain
General information
Reason for update
Acronym
SFBT
IRCT registration information
IRCT registration number:IRCT20200513047431N1
Registration date:2020-07-28, 1399/05/07
Registration timing:retrospective
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
Registrant information
Name
Mahdieh Mohiti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 0816
Email address
mohitim1390@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-22, 1399/03/02
Expected recruitment end date
2020-07-23, 1399/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women
Public title
The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy age 37 to 41 weeks
Fetal health in the first trimester ultrasound examination
The pregnant mother has no special medical or midwifery problems
Wanted pregnancy
Exclusion criteria:
History of psychotherapy or mental illness
addiction to cigarettes and drugs and alcohol
Have a history of recurrent miscarriage and infertility
Taking anti anxiety and anti depressant drugs
The onset of labor pains
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Using the website https://www.sealedenvelope.com/simple-randomiser/v1/lists، and with the help of the methodological consultant ، the allocation sequence is generated. The 4-block method is used to create the allocation sequence. Within each block half of the intervention people and half as a control are considered. White envelopes are used to hide the sequence. In this way each sequence is placed inside a white envelope and the envelopes are placed side by side and envelopes are numbered. An envelope is opened for each person in the order in which they enter the study and assigned to the desired group. Participants are not blind because they are trained . After the intervention the questionnaires are completed by a person who is not aware of their group. The information analyst is also not aware of the group of the people.
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 Shahroud University of Medical Sciences
Street address
No. 28,Khayyam 25 Alley.,Khayyam Ave.,Farhangian Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318733333
Approval date
2020-05-15, 1399/02/26
Ethics committee reference number
IR.SHMU.REC.1399.048
Health conditions studied
1
Description of health condition studied
Anxiety and labor pain intensity
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety level in nulliparous womens
Timepoint
Anxiety assessment before intrevention begins and after consuling in dilatations 5 and 8 cm of servics of servics
Before intervention and after intervention in dilatation 5, 8,10 cm cervics
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Perform short-term focus counseling before labor pains begin،single session counseling is a solution oriented approach for mothers who have not attended childbirth preparation classes during pregnancy and they have anxiety.For the mothers of the intervention group in addition to the routine care of the ward the researcher conducts one session Solution Focused Brief counseling for 45 to 60 minutes ،it is done individually. Solution Focused Brief counseling is a strengths based model. With different techniques and reminders of exceptions ،it helps pregnant mothers to recognize their abilities and overcome their anxiety during childbirth. Techniques used: Immediate relaxation or abdominal breathing. Riding on the wave of terror. Education Autogenic. Technique Just because. Mindfulness. Fan 12345. Courage ladder.
Category
Behavior
2
Description
Control group: Get routine care of the ward but they do not receive advice
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim hospital
Full name of responsible person
Mohiti Mahdieh
Street address
Basige Squ.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318633333
Phone
+98 51 4263 8001
Email
mohitim1390@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Emamiyan Mohammad Hasan
Street address
Hafte Tir Squ.
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Mohiti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.28, 25 Khayyam Alley ., Khayyam Ave. , Farhangian Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318733333
Phone
+98 51 4261 0816
Fax
Email
mohitim1390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Mohiti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.28, 25 Khayyam Alley ., Khayyam Ave. , Farhangian Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318733333
Phone
+98 51 4261 0816
Fax
Email
mohitim1390@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mahdieh Mohiti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.28, 25 Khayyam Alley ., Khayyam Ave. , Farhangian Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
9318733333
Phone
+98 51 4261 0816
Fax
Email
mohitim1390@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effectiveness of focused solution brief counseling on anxiety and labor pain intensity in nulliparous women
When the data will become available and for how long