Study objective: The aim of this study was to evaluate the effect of structured counseling a midwife on grief and bereavement after miscarriage. Design: This study was a randomized clinical trial with two groups (experimental and control), pre and post-test design, and not-blind. Setting and conduct: This study was conducted on 60 women hospitalized in women department of Omolbanin, Imam Reza and Ghaem hospitals of Mashhad that were randomly divided into two groups (n = 30). Inclusion criteria: 18-35 years old; Spontaneous abortion under 20 weeks. Exclusion criteria: withdraw from the study participation for any reason. Intervention: in experimental group was conducted structured counseling in two 90-minute session by the researcher immediately after abortion during hospitalization and in control group received routine educations (educational pamphlet). A telephone meeting was considered next week after second meeting. The main outcome variables in this study included: grief and bereavement that in both groups was assessed before the intervention, 4 and 8 weeks after the abortion with grief and bereavement questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022324469N1
Registration date:2016-09-13, 1395/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-13, 1395/06/23
Registrant information
Name
Maryam Alizadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3259 2688
Email address
alizadehm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-23, 1395/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Structured Counseling of Midwife on Grief and Bereavement after Miscarriage
Public title
The Effect of Structured Counseling of Midwife on Grief and Bereavement after Miscarriage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18-35 years old; definitive diagnosis of abortion by ultrasound; Spontaneous abortion under 20 weeks. Exclusion criteria: withdraw from the study participation for any reason.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.MUMS.REC.94.877
Health conditions studied
1
Description of health condition studied
Grief
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
2
Description of health condition studied
Bereavement
ICD-10 code
Z63.4
ICD-10 code description
Disappearance and death of family member
Primary outcomes
1
Description
Grief after miscarriage
Timepoint
Before the intervention, 4 and 8 weeks after the abortion
Method of measurement
Grief questionnaire after miscarriage
2
Description
Bereavement after miscarriage
Timepoint
Before the intervention, 4 and 8 weeks after the abortion
Method of measurement
Bereavement questionnaire after miscarriage
Secondary outcomes
1
Description
Bereavement after Miscarriage on women
Timepoint
Before the intervention, 4 weeks after the intervention, 8 weeks after intervention
Method of measurement
The questionnaire perinatal Bereavement
Intervention groups
1
Description
Intervention group: in intervention group was conducted structured counseling in two 90-minute sessions by the researcher immediately after abortion during hospitalization. A telephone meeting was considered next week after second meeting. Grief and bereavement of women was assessed before the intervention, 4 and 8 weeks after the abortion with grief and bereavement questionnaires.
Category
Behavior
2
Description
Control group: in this study, no intervention was administered to the control group and women received routine educations (educational pamphlet). Grief and bereavement of women in this group was assessed before the intervention, 4 and 8 weeks after the abortion with grief and bereavement questionnaires, too.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Omolbanin hospital
Full name of responsible person
Nahid Ebrahimi
Street address
Women Department, Omolbanin Hospital, Ayatolah Bahjat St, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Elham Rezaee
Street address
Women Department, Imam Reza Hospital, Ebne Sina St, Imam Reza Square, Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Akram Arta
Street address
Women Department, GHaem Hospital, Ahmad Abad St, Dr Shariati Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
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
School of Nursing and Midwifery
Full name of responsible person
Maryam Ahmadi
Position
Master of Science Student in Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3607 8926
Fax
Email
Ahmadim931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Nahid Golmakani
Position
Master of Science in Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3852 8512
Fax
Email
Golmakanin@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Maryam Ahmadi
Position
Master of Science Student in Midwifery
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
00
Fax
Email
Ahmadim931 @mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)