Revising of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in women with infertility and (its) effectiveness on their health- related quality of life and sexual satisfaction in women with infertility.
If the research hypotheses are proven, Acceptance and Commitment therapy (ACT) can be used in treatment centers to help treat women with infertility and have a significant role in improving the quality of life associated with the health and sexual satisfaction of these patients.
Design
En Controlled clinical trial, not blind, randomized design
Settings and conduct
At the Isfahan ..............., patients' files are reviewed and interviewed in the presence of the Dr. Mofid. If satisfied, patients complete the questionnaires in the pre-test and post-test stages.The treatment protocol is performed in 8 sessions on the intervention group at the Dr. Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 40 years; Diagnosed infertility in patients who completed standard therapies; Exclusion criteria: Mental disorders
Intervention groups
The ACT Therapy protocol will be administered to the experimental group to improve health-related quality of life and sexual satisfaction in women with infertility , and the control group will continue their treatment.
Main outcome variables
The main implications of this study are: sexual satisfaction as measured by sexual satisfaction questionnaire; Quality of life is dependent on health as measured by the questionnaire (SF 36). The main consequences are pre-test and post-test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046527N1
Registration date:2020-03-19, 1398/12/29
Registration timing:registered_while_recruiting
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Shiva Koohi Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3448 2848
Email address
sh.koohikamali@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Revising of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in women with infertility and (its) effectiveness on their health- related quality of life and sexual satisfaction in women with infertility.
Public title
"The effect of Acceptance and Commitment Therapy (ACT) protocol on women with infertility"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
En Willingness to participate in the research project
Age 20-40 years
Having a diploma degree
At least one year under treatment (with expert approval)
No addiction to any drug
Completion of consent to participate in the research
Low Quality of Life Quality of Life and Sexual Satisfaction Questionnaires
Exclusion criteria:
Use of psychoactive drugs
Age
From 20 years old to 40 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
Since the study groups have equal sample size, we use simple random allocation law which is one of the limited randomization methods and we divide people into two groups of intervention and control. Keep notes of patients on 40 separate sheets and place the sheets inside the draw container and then we randomly record the 20 sheets out of the container into the intervention group and place the remaining 20 sheets in the control group. If there is a loss in treatment sessions, the sample size will be randomly eliminated in order to equalize the sample size and eventually the number of subjects in both groups should be the same. The experimental group (n=20) will have 8 sessions of 120-minute Acceptance and Commitment therapy and the control group will receive no intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd., Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.310
Health conditions studied
1
Description of health condition studied
women with infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Scale on sexual satisfaction ; Physical and Mental Health Score in Health Related Quality of Life Questionnaire (SF 36)
Timepoint
At the beginning of the study (before the intervention) and after 8 sessions of acceptance and commitment group therapy
Method of measurement
Health Related Quality of Life Questionnaire (SF 36); sexual satisfaction
Secondary outcomes
1
Description
Health-related quality of life score and Scale on sexual satisfaction
Timepoint
Health-related Quality of Life Questionnaires (SF 36) and Scale on sexual satisfaction at baseline (before intervention) and after treatment protocol
Method of measurement
The sexual satisfaction Questionnaire (DASS 21) Health-related quality of life (SF 36)
Intervention groups
1
Description
Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of sexual satisfaction and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks.
Category
Behavior
2
Description
Control group: Twenty patients with prostate cancer who complete the pre-test questionnaire of sexual satisfaction and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Milad Hospital
Full name of responsible person
Dr. Abdollah Ghahiri
Street address
Shahrak-e Vali Asr
City
Esfahan
Province
Isfehan
Postal code
8173664433
Phone
+98 31 3777 4002
Email
ghahiriig@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
دکتر علیرضا روستا
Street address
Sana'i Boulevard, Free Zone Organization Square, Islamic Azad University of Kish International Branch
City
kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Fax
+98 76 4442 3957
Email
Info@IaukishInt.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Shiva Koohikamali
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 23, Alley 9, Kasra st.
City
Karaj
Province
Alborz
Postal code
3144968547
Phone
026344828418
Email
shivakoohi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
دکتر حمید پورشریفی
Position
دانشیار روانشناسی سلامت
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0045
Email
ha.poursharifi@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shiva Koohi kamali
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 23, Alley 9, Kasra st.
City
Karaj
Province
Alborz
Postal code
3144968547
Phone
026344828418
Email
shivakoohi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
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