Determine the effectiveness of quality of life therapy on anxiety, perceived stress, general health and quality of life in pregnant women in Isfahan.
Design
This study had semi experimental design with pre-test, post-test and follow-up measurements comparing with attention control group. From pregnant women to Shaid Behshti Hospital in Isfahan. 50 participants were available sampling method selected and assigned to the group quality of life therapy intervention or attention control randomly using concealed cards.
Settings and conduct
This study examined the effectiveness quality of life therapy on psychological pregnant women. This study was performed on pregnant women referred to Shahid Behshti Hospital of Isfahan. Measurements were performed at pre-test, post-test and follow-up. The intervention was created theory of psychotherapy based on Frsch quality of life improvement. Experimental group received quality of life therapy during 8 sessions(90 minutes, for 8 weeks) and control group received routine medical education for pregnancy period without any psychological trainings. participants were blind to grouping. Statistical analysis were also blind to grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Pregnancy 2- Inclination to participat in research
Exclusion criteria: 1- Acute psychiatric disorders 2- Get other psychological interventions
Intervention groups
Experimental group received group quality of life therapy during 8 sessions (90 minutes, for 8 weeks) and attention control group received routine medical education for pregnancy period without any psychological trainings.
Main outcome variables
Effectiveness of quality of life therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190620043956N1
Registration date:2019-09-03, 1398/06/12
Registration timing:retrospective
Last update:2019-09-03, 1398/06/12
Update count:0
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Nooshin Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
nooshinheidari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2017-03-10, 1395/12/20
Trial completion date
2017-07-06, 1396/04/15
Scientific title
The Study of the effectiveness of Group Quality of life Therapy on Anxiety, Perceived Stress, General Health and Quality of life of Pregnant Women
Public title
The Study of the effectiveness of Group Quality of life Therapy on Pregnant Women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women
Reading and writing education
Inclination to participat in research
Exclusion criteria:
Acute psychiatric disorders
Unwillingness to complete the research process
Get other psychological interventions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
This is a randomized trial that examine Quality of life Therapy intervention among pregnant women who were randomly selected from among referrals to Shahid-Beheshti Hospital in Isfahan. Participants were then randomized to the psychological wellbeing intervention or the control condition using concealed cards with group assignment listed that were only accessed by research team members following completion of baseline assessments.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study participants were blind about the groupings. Also group assignment listed were only accessed by research team members following completion of baseline assessments. Statistical analysts were also blind to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
islamic azad university khorasgan branch
Street address
University Blvd, Arghavanieh, The East Jey St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۶۱۷۷۴۳۱۱۱
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.055
Health conditions studied
1
Description of health condition studied
Pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of Life Score for Pregnant Women in the World Health Organization Quality of Life Questionnaire (2004)
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Measurement tools included the World Health Organization Quality of Life Questionnaire - Short Form (WHOQOL-BREF)(2004).
Secondary outcomes
1
Description
Anxiety
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Instruments included beck anxiety inventory(1990)
2
Description
Perceived Stress
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Instruments included Cohen perceived stress questionnaire (1983)
3
Description
General health
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Instruments included Goldberg and Hiller general health questionnaire (1979)
Intervention groups
1
Description
Intervention group received Group Quality of Life Therapy based on Frisch Quality of Life Therapy during 8 sessions (weekly, 90 minutes, for 8 weeks).
Category
Lifestyle
2
Description
Control group received routine medical education for pregnancy period without any psychological trainings during 8 sessions (weekly, 90 minutes, for 8 weeks).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Nooshin Heidari
Street address
Shahid Beheshti hospital, Shahid Motahari St, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8148445613
Phone
+98 31 3236 7001
Email
nooshinheidari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toghiani
Street address
University Blvd, Arghavanieh, The East Jey St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
info@khuisf.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Nooshin Heidari
Position
M.A.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University Blvd, Arghavanieh, The East Jey St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
nooshinheidari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholam Reza Nikrahan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Blvd, Arghavanieh, The East Jey St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
rezanikrahan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nooshin Heidari
Position
M.A.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University Blvd, Arghavanieh, The East Jey St.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
nooshinheidari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The total potential data can be shared after being "unidentifiable"
When the data will become available and for how long
Start the access period 6 months after publishing of the results
To whom data/document is available
It will be accessible for everyone
Under which criteria data/document could be used
There will be no specific condition
From where data/document is obtainable
nooshinheidari@yahoo.com
What processes are involved for a request to access data/document
There will not be any specific process, we will be responsive after receiving an email