Formulation of a psychological empowerment package for infertile women in pre treatment stage (IVF) and comparison of its effect with dialectical behavior treatment on depression anxiety,infertility stress sexual satisfaction and hope.
Psychological Empowerment of Infertile Women and Comparison of the Effectiveness of Psychological Empowerment Therapy with Dialectical Behavior Therapy
Design
Dialectical Behavior Therapy and Psychological Empowerment group with control group, with parallel groups, randomized
Settings and conduct
This research will be a combination of qualitative and quantitative methods. In order to develop a qualitative psychological empowerment package, 83 sources will use, including articles, books, and dissertations, and will code using sterling content analysis, so continued to the point that no new information remained. To perform the quantitative method, which will include two groups of psychological empowerment training and dialectical behavioral therapy, after selecting infertile women, applicants for IVF treatment who referred to infertility centers in Isfahan will be place in two training groups with informed consent.Those will receive the necessary training at the institutes located in shahinshahr and the control group will not receive any training.
Participants/Inclusion and exclusion criteria
Entry requirements
Volunteer for IVF treatment
primary infertility
Iranian citizenship
Non-arrival conditions
Being under other psychological treatments
Consumption of addictive substances
Unmotivated and dissatisfied
Intervention groups
Dialectical Behavioral Therapy Group is trained using the Linehan package for 8 sessions and the Empowerment Group is trained for 11 sessions; The training control group does not receive any instruction.
Main outcome variables
Depression, Anxiety, Infertility stress, Sexual Satisfaction, Hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200319046815N1
Registration date:2020-05-06, 1399/02/17
Registration timing:registered_while_recruiting
Last update:2020-05-06, 1399/02/17
Update count:0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
Azadeh Bahrami kerchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4527 2935
Email address
a.bahrami2657@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-07, 1398/11/18
Expected recruitment end date
2020-09-01, 1399/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of a psychological empowerment package for infertile women in pre treatment stage (IVF) and comparison of its effect with dialectical behavior treatment on depression anxiety,infertility stress sexual satisfaction and hope.
Public title
The Effectiveness of Psychological Empowerment Therapy and Dialectical Behavior Therapy on Depression, Anxiety, Infertility Stress, Sexual Satisfaction and Hope.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer for IVF treatment
Being in the age group of 30 to 45
Primary Infertility
Iranian citizenship
Marriage during research
Exclusion criteria:
Being under other psychological treatments
Acute psychiatric illness to psychiatrist diagnosis
Consumption of addictive substances
Unmotivated and dissatisfied
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Accidentalization will be done on a regular basis. In this way, everyone in the community has an equal chance of being elected. First, a list of people is obtained, then a score or number is assigned to each of them, and the desired number is selected using a table of random numbers.
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 Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
Isfahan, East Jey Ave, Arghavaniyeh, Daneshgah Blvd, Azad university
City
Isfahan
Province
Isfehan
Postal code
0000000000
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.085
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
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
3
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
4
Description of health condition studied
infertility stress
ICD-10 code
F40-F48
ICD-10 code description
Stress neurotic
5
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Hope
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression
Timepoint
7 days before training and follow-up 45 days after training
Method of measurement
Personal score on the depression scale of the DASS questionnaire
2
Description
Anxiety
Timepoint
7 days before training and follow-up 45 days after training
Method of measurement
Personal score on the anxiety scale of the DASS questionnaire
3
Description
Infertility Stress
Timepoint
7 days before training and follow-up 45 days after training
Method of measurement
Personal score in the Newton questionnaire
4
Description
Sexual Satisfaction
Timepoint
7 days before training and follow-up 45 days after training
Method of measurement
Personal score in LINDABERG and GRACY questionnaire
5
Description
Hope
Timepoint
7 days before training and follow-up 45 days after training
Method of measurement
Personal score in the Schneider questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Dialectical Behavioral Therapy Intervention Group: they will be treated for 8 sessions, 90-minute using Linehan Dialectical Behavioral Therapy package and They will receive mindfulness skills, endurance tolerance and effective interpersonal skills and the necessary psychological training in recognizing and controlling emotions. .
Category
Other
2
Description
Psychological Empowerment Intervention Group: using the psychological empowerment package developed for 11 sessions, 90 minutes, they will receive necessary psychological training in the field of cognitive distortion and the replacement of rational thoughts. , Increased self-awareness, skill of expression and management of anger and gradual muscle relaxation for eight muscle groups .
Category
Other
3
Description
Control group:This group included 15 infertile women who did not receive any training.