The purpose of this study is investigating the effect of Acceptance and Commitment Therapy (ACT) on anxiety and quality of life in infertile women during treatment. Infertile women referred to Arak Infertility Center are the population of the study in this Randomized Control Trial. The samples of the study are 40 women with eligibility criteria. Participants randomly assign into control and experimental groups (20 people in each group). Inclusion criteria: women 18-45 years old؛ Diagnosis of Infertility؛ literacy؛ not have somatic and psychiatric diseases؛ Non-smoking and drugs؛ No history of assisted reproduction treatment؛ Having mild anxiety and average according to Beck Anxiety Inventory. Exclusion criteria: Lack of regular attendance to counseling sessions؛ Positive pregnancy test؛ Unpredictable events and crises that trigger anxiety؛ such as death of a loved and desire to exit from the study. The experimental group receives ACT for 8 sessions for 90minutes once a week and individuals in control group did not receive any intervention. All participants will complete Beck Anxiety Inventory and fertility quality of life questionnaire (fertiQol international) before the intervention؛ immediately after the intervention and one month after the intervention completion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082129453N1
Registration date:2016-09-24, 1395/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Elahe Rahimi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 3322
Email address
e.rahimi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2016-09-18, 1395/06/28
Expected recruitment end date
2016-12-18, 1395/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Acceptance and Commitment Therapy(ACT) on anxiety and quality of life in infertile women during treatment.
Public title
The effect of counseling on anxiety and quality of life in infertile women during treatment.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women 18-45 years old؛ Diagnosis of Infertility؛ literacy؛ not have somatic and psychiatric diseases؛ Non-smoking and drugs؛ No history of assisted reproduction treatment؛ Having mild anxiety score (8-15) and average anxiety score (16-25) according to Beck Anxiety Inventory.
Exclusion criteria: Lack of regular attendance to counseling sessions؛ Positive pregnancy test؛ Unpredictable events and crises that trigger anxiety: such as death of a loved and desire to exit from the study.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
3848176941
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.ARAKMU.REC.1395.153
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female Infertility
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized Anxiety Disorder
3
Description of health condition studied
Quality of life
ICD-10 code
_
ICD-10 code description
_
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention؛ immediately after intervention؛ one month after intervention completion
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention؛ immediately after intervention؛ one month after intervention completion
Method of measurement
Fertility quality of life questionnaire (fertiQol international)
Intervention groups
1
Description
Intervention group: Experimental group receive Acceptance and Commitment Therapy (ACT) in 90minutes sessions once a week for a total of eight sessions
Category
Behavior
2
Description
Control group: No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Infertility Center
Full name of responsible person
Elahe Rahimi
Street address
Shahid Beheshti Street, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Mr Doctor Mohamad Rafeie
Street address
University Research Assistant, Sardasht, Arak
City
Arak
Grant name
13640000ریال
Grant code / Reference number
2628
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Arak University of Medical Sciences
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
Elahe Rahimi
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
+98 38 4817 6941
Email
e.rahimi@arakmu.ac.ir؛ ee.rahimii@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Attarha
Position
PhD in Reproductive Health and Faculty member
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
+98 38 4817 6941
Email
m.attarha@arakmu.ac.ir؛ mahtab_at2004@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
Elahe Rahimi
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
+98 38 4817 6941
Email
e.rahimi@arakmu.ac.ir؛ ee.rahimii@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)