To evaluate the effectiveness of logo therapy on depression and acute stress disorder scores in women after vaginal delivery: randomized clinical trial
Objectives: Our study aimed to evaluate the effectiveness of Logotherapy on Depression and Acute Stress Disorder in the women after vaginal delivery. Design: A randomized clinical trial without blinding. Setting and conduct: In this study, New mothers with vaginal delivery who are admitted to the postpartum of Bahar hospital after obtaining informed consent, Complete Edinburgh postnatal depression scale & Impact of Event Scale-Revised and based on blocks with a size of four are randomly divided into 2 groups, control and intervention. Inclusion criteria: Having at least a high school diploma; No history of psychiatric inpatients; At least 18 years of age. Exclusion criteria: The use of psychiatric drugs; Neonatal death and Crises in life. Intervention: Logotherapy counseling as interventions compared with routine care will implement individually within the first 5 to 24 hours after delivery, for 40-60 minute. The outcome will assess with Revised Impact Event Scale (IES-R), in 2 and 4 weeks after intervention, then mean ASD and depression can be compared with each other. Main outcome measures variables: Acute stress disorder; and depression
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051433964N1
Registration date:2017-07-02, 1396/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Faride Abbasi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7989
Email address
abbasi.f@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-11-02, 1396/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effectiveness of logo therapy on depression and acute stress disorder scores in women after vaginal delivery: randomized clinical trial
Public title
The effect of logotherapy on depression and stress of postpartum women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having at least a high school diploma; No history of psychiatric inpatients; At least 18 years of age
Exclusion criteria: The use of psychiatric drugs; Neonatal death and Crises in life
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
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
Central building of Shahroud university of medical sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.shmu.rec.1396.17
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F31.3
ICD-10 code description
Bipolar affective disorder, current episode mild or moderate depression
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, 2 and 4 weeks after the end of intervention
Method of measurement
Edinburgh questionnaire
2
Description
Acute stress disorder
Timepoint
Before the intervention, 2 and 4 weeks after the end of intervention
Method of measurement
IES-R questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group During 5 to 24 hours after delivery receive individual counseling by graduate students in midwifery counseling, for 60-40 minutes.
Category
Prevention
2
Description
Controlled group Receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Farideh Abbasi
Street address
Bahar Hospital, Opposite to Koodak park, 22 Bahman St., Shahroud
City
shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammad Hassan Emamian
Street address
Central building of Shahroud university of medical sciences, Hafte Tir Square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Faride Abbasi
Position
Master science student of midwifery counseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
f.abbasi517@yahoo.com; abbasi.f@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Giti Atashsokhan
Position
Faculty member
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 5054
Fax
Email
atashsokhan@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Faride Abbasi
Position
MSc student of Midwifery Conseling
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3239 7989
Fax
Email
f.abbasi517@yahoo.com; abbasi.f@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)