A comparative assessment of midwife-led counseling and "music and evidence based booklet package" on birth fear and its outcomes in pregnant women referred to the comprehensive health care centers
The three-group, parallel randomized control trial study, which aimed to evaluate the effectiveness of combining music and midwife-led counseling on birth fear and its consequences. The study population will comprise pregnant women. A sample of 186 pregnant women has been calculated. Inclusion criteria with block randomization placed in one of two intervention and control groups. The main criteria are nulliparous women with 29-14 weeks gestation and the main score of birth fear would be less than 66 on WIJMA-A questionnaire, miscarriage or fetal death. The two intervention groups based midwife-led counseling and music. 4 weekly sessions of group counseling and each session is 60 minutes. The music group at the same time will listening to self-selected music part for 15-30 minutes at home and would mark their checklist. Before and after the intervention and 2 weeks after the last sessions, the outcomes of birth fear will be assessed, comprise of decision-making conflict, anxiety, depression, and self-efficacy are likely to be measured by questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030627557N3
Registration date:2017-05-28, 1396/03/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Mahnaz Akbari Kamrani
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
dr.akbarikamrani@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-04-19, 1396/01/30
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative assessment of midwife-led counseling and "music and evidence based booklet package" on birth fear and its outcomes in pregnant women referred to the comprehensive health care centers
Public title
A comparative assessment of midwife-led counseling and “music and evidence based booklet package”on birth fear in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:primiparous women 29-12 weeks attend to get free prenatal care; women must have the ability to communicate;ability to read and write, be 18 years of age or older.
Exclusion criteria: having acute and chronic neuropsychiatric disorders; neuropsychiatric drug use; proven fetal abnormalities; impaired hearing; not wanting to continue collaborating in the study; less fear score of 66 with WIJMA-A questionnaire; fetal death.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
Department of Midwifery, Alborz University of Medical Sciences, Eshteraki St., Baghestan Blv
City
Karaj
Postal code
56131452
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
Abzums.Rec.1395.149
Health conditions studied
1
Description of health condition studied
Birth fear
ICD-10 code
F40.8
ICD-10 code description
Other phobic anxiety disorders
Primary outcomes
1
Description
Birth fear
Timepoint
Before and after intervention, 2 weeks after the end of intervention
Method of measurement
WDEQ-version A questionnaire
Secondary outcomes
1
Description
Self-efficacy
Timepoint
Before and after of intervention, 2 weeks after end of intervention
Method of measurement
Child Birth Self-efficacy Inventory questionnaire
2
Description
Decision conflict
Timepoint
Before and after of intervention, 2 weeks after end of intervention
Method of measurement
Decision Conflict Scale
3
Description
Mood of delivery
Timepoint
Before and after of intervention, 2 weeks after end of intervention
Method of measurement
Obstetric's information Questionnaire
4
Description
Anxiety
Timepoint
Before and after of intervention, 2 weeks after end of intervention
Method of measurement
STAI questionnaire
5
Description
Depression
Timepoint
Before and after of intervention, 2 weeks after end of intervention
Method of measurement
Edinburgh Postnatal Depression Scale
Intervention groups
1
Description
First group:
Midwife-led counseling group, Receive 4 sessions counseling intervention in 26-33 weeks gestation.
Category
Behavior
2
Description
Second group:
Music listening group will listen a self selected classical music part for 15-30 minutes daily in 26-33 weeks gestation. An evidence base booklet has been prepared for this group about birth fearing.
Category
Behavior
3
Description
Third group:
Control group will receive routine prenatal care, In 26-33 weeks gestation. They will receive an evidence based booklet about birth fearing.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Comprehensive Health Care Center
Full name of responsible person
Yalda Shakouri Masouleh
Street address
Alghadir Building, Bahman St., Rahahan Blv.
City
Hashtgerd New city
2
Recruitment center
Name of recruitment center
Kalimollah Maadandar Comprehensive Health Care Center