Objectives: Study on effects of psychological counseling on grief and post-traumatic stress symptoms in mothers after stillbirth.
Design: This is a semi-experimental study with the Pretest - Post test plan. The study population includes all women whose children were born dead during the last 1 to 4 weeks and have the inclusion criteria. The study population consist of 100 people. The selected individuals will be randomly divided in to the two groups of intervention and control.
First, according to the number of the subjects, envelopes containing the names of the groups (A and B) will be randomly arranged and then based on the referring of the desired qualified people, one of the envelopes which determines the respective group will be allocated to each person. Then the questionnaires are explained by the researcher or her colleague and will be completed as a pretest. Four 90-minute sessions of psychological counseling grief will be formed in groups-individual by the researcher within two weeks for the intervention group in the related health centers. Four weeks after the last counseling session, questionnaires will be filled in both groups again as the post-test. In the end, booklet or CD containing educational content of the sessions will be provided to the control group if desired.
Inclusion criteria: The recent history of stillbirth (1-4 weeks ago); Exclusion criteria: Being absent in more than one counseling session.
Finally, the intensity of grief and post-traumatic stress of two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092629980N1
Registration date:2016-11-22, 1395/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-22, 1395/09/02
Registrant information
Name
Zahra Saravani
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3224 0535
Email address
zahra.saravani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Psychological Counseling on Grief and Post-Traumatic Stress Symptoms in Mothers After Stillbirth.
Public title
Effect of counseling on grief in mothers after stillbirth
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The recent history of stillbirth (1-4 weeks ago); Older than 18 years; Literate; No history of infertility; The lack of stillbirth history in previous Pregnancies; The lack of psychiatric disorders and drug abuse history; The lack of first-degree relatives death experience or other severe crises in the last year.
Exclusion criteria: Being absent in more than one counseling session; Crisis or death during the study.
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Zahedan University of Medical Science
Street address
University of Medical Sciences, Dr. Hesabi Square, Zahedan
City
Zahedan
Postal code
9816743463
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
IR.ZAUMS.REC.1395.65
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder
2
Description of health condition studied
stillbirth
ICD-10 code
Z37.1
ICD-10 code description
Single stillbirth
3
Description of health condition studied
grief
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
Primary outcomes
1
Description
grief
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
PGS questionnaire
2
Description
post-traumatic Stress disorder
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
PPQ questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, questionnaires will be filled in Intervention group as the pretest.
Four 90-minute sessions of psychological counseling grief will be formed in groups-individual by the researcher within two weeks for the intervention group in the related health centers. Booklet or CD containing educational content of the sessions will be provided to the intervention group, too. Four weeks after the last counseling session, questionnaires will be filled in both groups again as the post-test.
Category
Rehabilitation
2
Description
Control group: First, questionnaires will be filled in Control group as the pretest. Control group will not receive any intervention except routine care. 6 weeks later the questionnaires will be refilled as post-test. In the end, booklet or CD containing educational content of the sessions will be provided to the control group if desired, as well.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital in Zahedan
Full name of responsible person
Parvaneh Pahlavan
Street address
Ali Ebne Abi Taleb Hospital, Health Boulevard, Khalije Fars Boulevard, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Zahedan University of Medical Sciences, Zahedan, Iran.
Full name of responsible person
Hoshang Rafigh Doost
Street address
University of Medical Science, Dr. Hesabi Square, Zahedan, Iran
City
Zahedan
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 of Zahedan University of Medical Sciences, Zahedan, Iran.
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
Faculty of Nursing & Midwifery of Zahedan
Full name of responsible person
Zahra Saravani
Position
Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Zahedan, Mashahir Square, Zahedan
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2452
Fax
Email
saravani61@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan university of Medical Sciences
Full name of responsible person
Dr. Ali Navidian
Position
Associate professor of Zahedan University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Zahedan, Mashahir Square, Zahedan
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2452
Fax
Email
alinavidian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Saravani
Position
Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Zahedan, Mashahir Square, Zahedan, Iran
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)