Objective: to evaluate the effect of acceptance and commitment therapy on anxiety and quality of life in pregnant women.
Study population: pregnant women who come to health centers in Arak.
Study groups: intervention and control.
Sample size: 42 pregnant women.
Randomization: simple random sampling by Random number table.
Study method: random sampling from women who come to five different health centers in five areas in Arak city for prenatal care.
Demographic and Van den Berg questionnaire and quality of life questionnaire 36 item (SF36) given to women with inclusion criteria. 42 women are select by simple random sampling then divide to two groups, control and intervention. Intervention group divide into two groups of 10 and 11 persons. Given Van den Berg questionnaire and quality of life questionnaire 36 item (SF36) to women at the end of the 8th session and one month later.
Inclusion criteria: pregnant women in the second and third trimesters; age 18 to 35 years; no history of psychiatric disorders.
Exclusion criteria: absence of mother more than two sessions; lack of exercise and homework.
Interventions: 8 meeting hold based on acceptance and commitment therapy once a week and each session last for 90 minutes for intervention groups.
Primary outcome: effect on pregnant woman anxiety.
Secondary outcome: quality of life in pregnant women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092429949N1
Registration date:2016-10-20, 1395/07/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-20, 1395/07/29
Registrant information
Name
Fahimeh Zarei
Name of organization / entity
Arak Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 2551
Email address
f.zareie@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-10-26, 1395/08/05
Expected recruitment end date
2017-01-24, 1395/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the acceptance and commitment therapy on women anxiety in pregnancy
Public title
The effect of counseling on pregnancy anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women in the second and third trimesters; singleton; lack of chronic diseases; no history or risk of: abortion, signs of premature labor, infertility, hypertension, placental anomalies, rupture of membrane, obesity, diabetes; no history of psychiatric disorders; not taking psychotropic drugs; no history of hospitalization during pregnancy; at least primary education; age 18 to 35 years old; lack of unwanted pregnancy; no history of alcoholism, smoking and drugs
Exclusion criteria: absence of mother more than two sessions; no doing exercise and homework.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee Arak University of Medical Sciences
Street address
College of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
3848176941
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.ARAKMU.REC.1395.230
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
General anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, after intervention, one month after the intervention.
Method of measurement
Van den Bergh questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before intervention, after intervention, one month after intervention
Method of measurement
Quality of life Questionnaire 36 item
Intervention groups
1
Description
Intervention group: divide into two groups of 10 and 11 persons. 8 meeting hold based on acceptance and commitment therapy once a week and each session last for 90 minutes for intervention groups. We give brochure and home exercises at the end of the eighth session in order to help mothers remember class understandings and move toward the mother's values in life .
Category
Behavior
2
Description
Control group: no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arastoo health care center
Full name of responsible person
Fahime Zarei (Msc student in consultation midwifery)
Street address
Islam street, Imam Ali area
City
Arak
2
Recruitment center
Name of recruitment center
Karahrod health care center
Full name of responsible person
Fahime Zarei (Msc student in consultation midwifery)
Street address
Shahid Alaee street, Karahroud area
City
Arak
3
Recruitment center
Name of recruitment center
Hosseiny health care center
Full name of responsible person
Fahime Zarei (Msc student in consultation midwifery)
Street address
Adabjoo street
City
Arak
4
Recruitment center
Name of recruitment center
Shahid Nateghi health care center
Full name of responsible person
Fahime Zarei (Msc student in consultation midwifery)
Street address
Shenkesh street, Rahzan area
City
Arak
5
Recruitment center
Name of recruitment center
Ghaem health care center
Full name of responsible person
Fahime Zarei (Msc student in consultation midwifery)
Street address
Danesh street, Ghaem area
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences and vice Chancellor for research of Arak University of Medical S
Full name of responsible person
Dr Mohammad Rafiei
Street address
Vice Chancellor for research of Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Grant name
11405000
Grant code / Reference number
2249
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences and vice Chancellor for research of Arak University of Medical S
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
Arak University of Medical Sciences
Full name of responsible person
Fahime Zarei
Position
Msc student in consultation midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3502
Fax
Email
f.zarei53@gmail.com; f.zareie@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Katayon Vakilian
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3505
Fax
Email
k_vakili@arakmu.ac.ir; kattyv2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahime Zarei
Position
Msc student in consultation midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Collage, Arak University of Medical Sciences, Sardasht , Arak.
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3505
Fax
Email
f.zarei53@gmail.com; f.zareie@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)