The effect of counseling based on health promotion awareness on mental health and self-esteem in women with ectopic pregnancy: A randomized controlled clinical trial
Determine the effect of counseling on mental health and self-esteem in women with ectopic pregnancy
Design
The clinical trial with two groups of intervention and control, with parallel groups, without blinding, is randomized, with 34 participants in each group who will be followed up 2 weeks after the end of the intervention.
Settings and conduct
This randomized, controlled clinical trial will be conducted on women with ectopic pregnancy treated at al-Zahra hospital in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women with ectopic pregnancy who are admitted in surgical wards, Women who are at the reproductive age, Women who are willing to participate in the study. exclusion criteria: Women who have severe psychological problems, personal disorders and psychiatric disorders according to their own statements. women who use psychoactive drugs. women who have experienced mental and psychological problems like lost and losing their family members during last 3-6 months. women who have taken psychiatric drugs, including anti-anxiety and anti-depressant drugs before being pregnant. women who have had history of ectopic pregnancy and have had lose both of their uterine (Fallopian)tubes.
Intervention groups
A group as intervention group will receive 4-6 sessions of group counseling based on health promotion awareness by a researcher in a face to face way in 45-60 minutes. The control group will also receive routine care after ectopic pregnancy and the context of the consultation will be provided for them if they are inclined to do so at the end of study.The counselling sessions will be held a week after their discharge and will be held weekly for 4-6 weeks in a separate room (which has all facilities for counseling) at the Alzahra Hospital
Main outcome variables
ِDetermine of mean scores of mental health and self-esteem of women with ectopic pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100109003027N41
Registration date:2018-08-04, 1397/05/13
Registration timing:registered_while_recruiting
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on health promotion awareness on mental health and self-esteem in women with ectopic pregnancy: A randomized controlled clinical trial
Public title
The effect of counseling based on health promotion awareness on mental health and self-esteem in women with ectopic pregnancy: A randomized controlled clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with ectopic pregnancy who admitted in surgical wards
Women of reproductive ages
Women who are willing to participate in the study.
Exclusion criteria:
Women who, according to themselves expressions, have been severe psychological problems, personality disorder, and psychiatric disorders.
Women who use psychoactive drugs.
Women who have experienced mental and psychological problems like lacks and problems such as losing their loved ones in the last 3 to 6 months.
Women with a history of ectopic pregnancy who have lost both of their uterine (Fallopian) tubes.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who completed the pre-test questionnaires were randomly assigned to www.random.org and through block randomization with four and six blocks (stratification based on the tear of uterus tube and history of live child) and assigned a 1: 1 assignment ratio to two groups (one group receiving counseling and one control group). Block randomization will be done by the person who not involved in sampling and data analysis. To hide the allocation, the type of intervention will be written on the paper and will be placed in a series of consecutively numbered (1-68), sealed, opaque envelopes (Allocation Concealment).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
South Shariate Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-06-04, 1397/03/14
Ethics committee reference number
.IR.TBZMED.REC.1397.223
Health conditions studied
1
Description of health condition studied
ectopic pregnancy
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy, unspecified
Primary outcomes
1
Description
Determine of mental health score
Timepoint
Measurement of mental health score before intervention
Method of measurement
GHQ-28 questionnaire
2
Description
Determine of self-esteem score
Timepoint
Measurement of self-esteem score before intervention
Method of measurement
Rosenberg self-esteem questionnaire
3
Description
Determine of self-esteem score
Timepoint
Measurement of mental health score 2 weeks after the end of the intervention
Method of measurement
GHQ-28 questionnaire
4
Description
Determine of self-esteem score
Timepoint
Measurement of self-esteem score 2 weeks after the end of the intervention
Method of measurement
Rosenberg self-esteem questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention consists of 4 to 6 sessions of health awareness-rising counseling on a weekly basis.
Category
Other
2
Description
Control group: The control group will receive the routine care after ectopic pregnancy and will be given the counseling content at the end.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Fahime Sehhati Shafaie
Street address
South Shariati st.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
sehhatief@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz-Azadi St.- Golghast St.- Tabriz University of Medical Sciences- Central Building- No. 2- Jesh Vice Chancellor for Research
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
sehhatief@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sonia Hasani
Position
Ms. student of Midwifery education
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati st.Nursing and Midwifery faculty.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
shasani735@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahime Sehhati Shafaie
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati st.Nursing and Midwifery faculty.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
sehhatief@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fahime Sehhati Shafaie
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati st.Nursing and Midwifery faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
sehhatief@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome and the secondary outcomes after being unidentified, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers working in academic institutions
Under which criteria data/document could be used
In order to conduct research by researchers and under the terms of the law approved by the Declaration of the International Committee of Medical Publishers
From where data/document is obtainable
refer to the supervisor professor, Fahime sehhatie.
What processes are involved for a request to access data/document
After submitting the necessary documentation on the topic of research and approval by the relevant university