The effect of counseling based on acceptance and commitment therapy on middle-aged women`s quality of life
Design
A randomized clinical trial, with intervention and control group, parallel groups, on 62 women. Randomization using a quadruple block design.
Settings and conduct
This research will be a clinical trial study. The statistical population of this study will include middle-aged women referring to the health centers of Ahvaz city.
Participants/Inclusion and exclusion criteria
Conscious willingness to participate in research; Being literate in reading and writing; Age range between 40-60 years
Intervention groups
In the intervention phase, the test group will undergo group training during 8 counseling sessions with a counseling approach based on acceptance and commitment by the researcher. After coordinating with the people of the intervention group and contacting them to get their consent to attend the meetings regularly, once a week and on a certain day in a group for 1 to 1.5 hours in one of the classes of the center. Hygiene will be held. Thus, in each counseling session, a counseling program based on acceptance and commitment will be taught
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230418057954N1
Registration date:2023-05-09, 1402/02/19
Registration timing:registered_while_recruiting
Last update:2023-05-09, 1402/02/19
Update count:0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
Saba Rajabi Pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3462 1525
Email address
rajabi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-20, 1402/01/31
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on acceptance and commitment therapy on middle-aged women`s quality of life
Public title
The effect of counseling based on acceptance and commitment therapy on middle-aged women`s quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in research
Being literate in reading and writing
Age range between 40-60 years
Exclusion criteria:
having a history of known chronic and acute physical and mental illnesses and taking psychoactive drugs prescribed by a doctor or psychiatrist
Participation in clinical trials similar to this plan
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in the current study will be done in the form of simple randomization with a 4-block design according to the opinion of the respected professor of statistics. In this randomization method, 6 quadruple blocks are created as (aa,bb) (ab,ab) (ba.ba) (ab,ba) (ba,ab) (bb,aa) and written on separate sheets. Assuming that the letter a represents the intervention group and the letter b represents the control group. Then, in order to enter people into the study plan, one of the six sheets will be randomly removed, and in this way, 4 of the referring people will enter the intervention and control groups according to the lottery. In the same way, this process is repeated 16 times by lottery to complete the number of samples.
before the start of the study and immediately after the end of the study and two months after the end of the study
Method of measurement
SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group will undergo group training during 8 consultant sessions with a counseling approach based on acceptance and commitment by the researcher. After coordinating with the people of the intervention group and contacting them to get their consent to attend the meetings regularly, once a week and on a certain day in a group for 1 to 1.5 hours in one of the classes of the center. Hygiene will be held. Thus, in each counseling session, a counseling program based on acceptance and commitment will be taught.
Category
Lifestyle
2
Description
Control group: During the research period, no intervention will be done for the control group and they will do their daily activities and in order to appreciate them at the end of the intervention, they will be provided with a CD of exercises.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مراکز بهداشت غرب اهواز
Full name of responsible person
خانم باقری
Street address
Abouzar hospital
City
Ahvaz
Province
Khouzestan
Postal code
0000000000
Phone
+98 61 3445 7420
Fax
+98 61 3445 7420
Email
name@domian.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbas pour
Street address
Jundi Shapur University of Ahvaz, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 0000
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Saba Rajabi Pour
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University, Ahvaz, Faculty of Obstetrics and Midwifery
City
Esfahan
Province
Isfehan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
sabarajabi335@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra abbas pour
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University, Ahvaz, Faculty of Obstetrics and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
159
Phone
+98 61 3311 0000
Email
abbaspoor_Z762@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
saba rajabi pour
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Jundishapur University, Ahvaz, Faculty of Obstetrics and Midwifery
City
Esfahan
Province
Isfehan
Postal code
159
Phone
+98 61 3311 0000
Email
sabarajabi335@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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