The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout in female with premenstrual syndrome
The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout in female with premenstrual syndrome
Design
This clinical trial with control group, with parallel groups, randomized and without blinding will be performed on 30 women with Premenstrual Syndrome. Random allocation software is used for randomization
Settings and conduct
This study will be performed in Mashhad Health Center No. 1, a psychological method performed on female patients with premenstrual syndrome. Before and after the intervention, individuals will answer the relevant questionnaires. There will be no blinding in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria:At least one year has passed at least 190 on the PMS Having at least a high school diploma Deliberate signing of a written consent to participate in the research.
Exclusion criteria: DSM-V Axis I and II disorders Psychological and counseling services for marital issues in the last 3 months Psychiatric and psychotropic medication use 3 months before the first session The apparent risk of suicide right now
Intervention groups
Intervention group: Emotion-focused therapy enables one to identify, experience, accept, correct, manage, and produce one's emotions. female with premenstrual syndrome will receive 10 group sessions of emotion-focused therapy weekly for 10 sessions per week.
En Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group
Main outcome variables
pain perception؛ Self-Compassion؛ sexual function؛ Couple Burnout
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200117046157N1
Registration date:2020-12-04, 1399/09/14
Registration timing:retrospective
Last update:2020-12-04, 1399/09/14
Update count:0
Registration date
2020-12-04, 1399/09/14
Registrant information
Name
Maryam Ghodsi
Name of organization / entity
Education
Country
Iran (Islamic Republic of)
Phone
+98 51 4224 1090
Email address
mghodsi290@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-24, 1398/12/05
Actual recruitment start date
2020-07-26, 1399/05/05
Actual recruitment end date
2020-08-26, 1399/06/05
Trial completion date
2020-11-21, 1399/09/01
Scientific title
The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout in female with premenstrual syndrome
Public title
The effectiveness of emotion-focused therapy (EFT) on pain perception, Self-Compassion, sexual function and Couple Burnout
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed
At least 190 on the PMS
Having at least a high school diploma
Deliberate signing of a written consent to participate in the research
Exclusion criteria:
DSM-V Axis I and II disorders
Psychological and counseling services for marital issues in the last 3 months
Psychiatric and psychotropic medication use 3 months before the first session
The apparent risk of suicide right now
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
En The allocation method will be simple random. Hiding the assignment using a computer is that the computer creates random numbers between zero and one. If the random number is less than 0/5, the individual will be assigned to the test group, and if the random number is greater than 0/5, the individual will be entered into the control group. In this process, people who enter the study list will not be aware of how the treatment is allocated before the intervention.
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
Ethic Committee of Hakim Sabzevari University
Street address
Tovhid Town ,Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.HSU.REC.1398.030
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
pain perception
Timepoint
Before the intervention - 30 day After the intervention
Method of measurement
McGill Pain Questionnaire (1997)
2
Description
Self-Compassion
Timepoint
Before the intervention - 30 day After the intervention
Method of measurement
Self-Compassion Questionnaire Neff (2003)
3
Description
sexual function
Timepoint
Before the intervention - 30 day After the intervention
Method of measurement
sexual function Questionnaire (2000)
4
Description
Couple Burnout
Timepoint
Before the intervention - 30 day After the intervention
Method of measurement
Couple Burnout Questionnaire (2013)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women with premenstrual syndrome will undergo the intervention of the emotion-focused therapy group on a weekly basis for 10 sessions of 90 minutes of the Greenberg and Goldman (2019) emotion-focused treatment protocol. The summary of the content of each session is as follows: 1) Evaluate and create continuityassessment of expectations and concerns of women with pms. conceptualization of the problem and presentation of therapy logic and familiarity with general therapy rules. 2) identify the cycle of negative interactions and determine overall aims, creating a therapeutic agreement. 3) Strengthen continuity and analyze and change emotions. 4) Accepting emotions and identifying attachment needs, strengthening the interaction of group membersdiscover new solutions to old problems. 5) Accepting emotions and identifying attachment needs, strengthening group member interaction, discovering new solutions to old problems. 6) Creating new interactive patterns of emotion acquisitionIntimate engagement of clients with their couples, acceptance of new situations . 7) increasing the identification of attachment needs, facilitating the expression of needs and desires in sexualneeds using the technique of tracking and reflecting . 8) Focus on yourself, not the other person, more compassion for yourself, a framework for re-establishing sexual relation, deepening the couples sexual conflicts. 9) Orienting and Designing Interactions between Couples Replacing the Positive Interaction Cycle with the Negative Cycle. 10) Strengthening new situations and responses, supporting constructive interactive patterns, closing sessions.
Category
Behavior
2
Description
Control group: : This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center_1
Full name of responsible person
Samira Keramati
Street address
Health Center_1. between Vakilabad 66 and 68 ,Vakilabad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٩٧٩٣٩۴۵
Phone
+98 51 3501 8011
Email
hc١.pr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Ahmad Farzaneh kord
Street address
Tovhid Town , Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
farzaneh@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hakim Sabzevari 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
Education
Full name of responsible person
Maryam Ghodsi
Position
counselor
Latest degree
Master
Other areas of specialty/work
Family Counseling
Street address
Taleghani street
City
Neyshabur
Province
Razavi Khorasan
Postal code
9316735555
Phone
+98 51 4224 1090
Email
mghodsi290@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
دانشگاه حکیم سبزواری
Full name of responsible person
Hossein Shareh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
روانشناسی بالینی
Street address
Tovhid Town Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617666666
Phone
+98 51 4441 9050
Email
hsharreh@yahoo.com.au
Web page address
http://www.hsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
آموزش و پرورش
Full name of responsible person
Maryam Ghodsi
Position
مشاور
Latest degree
Master
Other areas of specialty/work
Family Counseling
Street address
Taleghani street
City
neyshabur
Province
Razavi Khorasan
Postal code
9316735555
Phone
+98 51 4224 1090
Email
mghodsi290@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available