The effectiveness of cognitive behavioral intervention on perceived stress and quality of life in women with abortion history: a randomized controlled clinical trial
Determining the effect of cognitive behavioral intervention on perceived stress in women with a history of abortion.
Design
Randomized controlled clinical trial
Settings and conduct
This study will be conducted on 62 women 15 to 49 women who have a history of abortion. Women will be selected using convenience sampling method and the perceived stress questionnaire will be completed through the interview by the researcher, and those who score above the cutting point 21.8 will be studied and informed consent will be obtained. Then the individual and social characteristics and the quality of life scales will be completed by researcher through the interview. Participants will be allocated to two groups of intervention and control by using the type of random blocking classified by the type of abortion (spontaneous -induced).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age of 15 to 49 years
2. Losing pregnancy less than 20 weeks of gestational age
3. Minimum education at the level of guidance
Exclusion criteria:
1.The history of self-reported mental illness
2. The history of self-reported chronic physical illness
3.Experience of a severe mental crisis over the past three months, such as the death of relatives
Intervention groups
For the intervention group (n=31), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week. The controls (n=31) will receive only the routine post abortion care.
Main outcome variables
The main outcome variable is perceived stress.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008459N16
Registration date:2024-02-11, 1402/11/22
Registration timing:prospective
Last update:2024-02-11, 1402/11/22
Update count:0
Registration date
2024-02-11, 1402/11/22
Registrant information
Name
Shirin Hasanpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
hasanpoorsh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral intervention on perceived stress and quality of life in women with abortion history: a randomized controlled clinical trial
Public title
The effect of counseling on perceived stress and quality of life in women with abortion history
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 and 49 years
Losing pregnancy less than 20 weeks of gestational age
at least secondary education
Exclusion criteria:
The history of self-reported mental illness
The history of self-reported chronic physical illness
The history of severe self-reported psychological crisis over the past 3 months, such as the death of relatives
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:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to two groups of intervention (consulting recipients) and control using the type of random blocking classified by the type of abortion (spontaneous and induced) with the size of the four and six blocks. In order to hide the allocation, the type of intervention on the written paper will be placed in the numbered and opaque envelopes. Envelopes will be opened in order of entry of participants to the study and the type of group of individuals will be determined.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.TBZMED.REC.1402.838
Health conditions studied
1
Description of health condition studied
perceived stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
perceived stress
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Cohen perceived stress questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
WHO Quality of Life questionnaire
Intervention groups
1
Description
Intervention group: For the intervention group (n=31), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week.
Category
Other
2
Description
Control group: The controls (n=31) will receive only the routine post abortion care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz health and treatment centers
Full name of responsible person
shirin Hasanpour
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5168743953
Phone
+98 41 3335 7310
Email
research-vice@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
Shirin Hasanpour
Position
Professsor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Hasanpour
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Physical Medicine and Rehabilitation Research Center, Imam Reza Hospital,Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3335 2081
Email
shirinhasanpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD