The purpose of this study is investigating the effect of Acceptance and Commitment Therapy (ACT) on infertility-related stress and child adoption. Infertile women referred to Isfahan Fertility and Infertility Center and Infertility Clinic of Isfahan Shahid Beheshti Hospital are the population of the study in this Randomized Control Trial. The samples of the study are 30 women with eligibility criteria and willingness to participate in this study. Inclusion criteria include: women 30-45 years old with primary infertility for 5 years and more, the history of Assisted Reproductive Technology failure (at least 1 time In Vitro Fertilization (IVF) or 3 times Intra Uterine Insemination (IUI) failure) and child adoption questionnaire's score less than 53 (mild and moderate attitude toward adoption). Participants randomly assign into control and experimental groups (15 people in each group). The experimental group receives ACT for 8 sessions for 2 hours twice a week and individuals in control group did not receive any intervention. All participants will complete Fertility Problem Inventory (FPI) and Child Adoption Questionnaire before the intervention, immediately after the intervention and one month after the intervention completion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120825428N1
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Tayebe Hajiyan
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
hajiyan.t@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Jundishapur University of Medical Science
Expected recruitment start date
2015-09-19, 1394/06/28
Expected recruitment end date
2015-11-19, 1394/08/28
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 infertility- related stress and adoption in infertile women
Public title
The effect of Acceptance and Commitment Therapy (ACT) on infertility- related stress and adoption in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women age 30-45 years; primary infertility 5 years and more; the history of Assisted Reproductive Technology (ART) failure (at least 1 time IVF or 3 time IUI failed); no history of psycological treatment; child adoption questionaire's score less than 53 (mild and moderate attitude toward adoption); tend to participate in the study
Exclusion criteria: the absence of more than two sessions; the case of psychological disorder ; pregnancy during sessions
Age
From 30 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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 Ahvaz Jundishapour University of Medical Science
Street address
Golestan blvd. Ahvaz Jundishapour University of Medical Science, Ahwaz, Iran
City
Ahvaz
Postal code
15794-61357
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.AJUMS.REC.1394.368
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Infetility-related stress
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
2
Description
Adopton
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Child adoption questionnaire
Secondary outcomes
1
Description
Social concern
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
2
Description
Relational concern
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
3
Description
Sexual concern
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
4
Description
Need for parentood
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
5
Description
Rejection of childfree lifestyle
Timepoint
Befor intervention, immediately after intervention and one month later
Method of measurement
Fertility Problem Inventory (FPI)
Intervention groups
1
Description
Experimental group receive group counseling based on Acceptance and Commitment Therapy (ACT) in two-hour sessions twice a week for a total of eight sessions.
Category
Behavior
2
Description
Control group: individuals in control group did not receive any intervention. For ethical consideration, after 3 evaluation, apply ACT session for control group if they want.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic, Shahid Behesht Hospital
Full name of responsible person
Tayebe Hajiyan
Street address
Motahary St. Infertility Clinic, Shahid Behesht Hospital, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Tayebe Hajiyan
Street address
Moshtagh St. Isfahan Fertility and Infertility Center, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Jondishapour University of Medical Science
Full name of responsible person
Dr. Nader Saki
Street address
Golestan blvd. Ahvaz Jondishapour University of Medical Science, ahwaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz Jondishapour University of Medical Science
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
Ahvaz Jondishapour University of Medical Science
Full name of responsible person
Tayebe Hajiyan
Position
MSc. Student of counseling in Midwifery
Other areas of specialty/work
Street address
Golestan Blvd, Ahvaz Jondishapour University of Medical Science, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3334 3926
Fax
Email
hajiyan.t@ajums.ac.ir; hajiyant@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Science
Full name of responsible person
Pourandokht Afshary
Position
Msc. midwifery (trainer)
Other areas of specialty/work
Street address
Golesten blvd. Nursing and Midwifery Faculty, Ahvaz Jondishapour University of Medical Science, Ahvaz
City
Ahvaz
Postal code
Phone
+98 613343926
Fax
Email
P_afshary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Science
Full name of responsible person
Tayebe Hajiyan
Position
Msc. student of Counseling in Midwifery
Other areas of specialty/work
Street address
Golestan Blvd, Nursing and Midwifery Faculty, Ahvaz Jondishapour University of Medical Science, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
hajiyant@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)