Determining the effect of emotional release technique on stress and resilience of infertile women
Design
The clinical trial has a control group of 98 patients, the selection of sample individuals in an easy and accessible way, and the allocation of the first 49 people as the control group and the second 49 people as the test group.
Settings and conduct
The research will be conducted in two selected infertility clinics in Bandar Abbas city. After learning the emotional release technique, the participants of the test group will perform the technique, and the control group will receive only routine care.
Participants/Inclusion and exclusion criteria
Entry criteria: Infertility confirmed by a gynecologist، At least one year has passed since the diagnosis of infertility ،Not having adopted children، No remarriage، Not suffering from medical diseases unrelated to infertility، No use of drugs in couples، No tension-causing incidents in the past 6 months Non-entry criteria: Failure to participate in more than one training session (that session should not be related to the session where the technique of freeing the mind is taught)
Intervention groups
Test: After completing the questionnaires, the participants will receive one training session of emotional release technique per week for 4 weeks, and 2 weeks after the last session, the questionnaires will be completed again; Control: After completing the questionnaires, they will receive routine care, and after 6 weeks, the questionnaires will be completed again.
Main outcome variables
Stress ; Resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220820055755N1
Registration date:2022-09-06, 1401/06/15
Registration timing:registered_while_recruiting
Last update:2022-09-06, 1401/06/15
Update count:0
Registration date
2022-09-06, 1401/06/15
Registrant information
Name
Marziyeh Torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3437 0206
Email address
marziyehtorabi99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing emotional release technique on stress and resilience of infertile women
Public title
Investigating the effect of implementing emotional release technique on stress and resilience of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility confirmed by a gynecologist
At least one year has passed since the diagnosis of infertility
Not having adopted children
No remarriage
Not suffering from medical diseases unrelated to infertility
No use of drugs in couples
No tension-causing incidents in the past 6 months
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Not 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
Working Group/Committee of Ethics in Research of Iran University of Medical Sciences
Street address
Iran Nursing and Midwifery School ,Rashid Yasemi Ave ,Vali-e-Asr Ave ,Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2022-07-25, 1401/05/03
Ethics committee reference number
IR.IUMS.REC.1401.335
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
infertility stress
Timepoint
Infertility stress measurement is done in the control group at the beginning of the study and 6 weeks later, and in the test group it is done at the beginning of the study and 2 weeks after the last session of emotional release technique training.
Method of measurement
In both groups, it will be measured by the researcher using Newton's infertility stress questionnaire.
2
Description
Resilience
Timepoint
Resilience measurement is done in the control group at the beginning of the study and 6 weeks later, and in the test group it is done at the beginning of the study and 2 weeks after the last session of emotional release technique training.
Method of measurement
In both groups, it will be measured by the researcher using the Connor and Davidson resilience scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: First, after completing the informed consent form, the participants will complete questionnaires of personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then, the mind release technique training based on the protocol for the participants in 4 sessions and at an interval of 1 week and to Group form will be provided. The first meeting will be held on the day of registration. The first session: introduction of the researcher and clients, introduction of the plan and the way of carrying out the project, explanation about stress, familiarity with infertility, benefits of increasing resilience, familiarity with the process of the impact of stress in the process of infertility treatment, familiarity with the technique of freeing the mind and familiarity with the sensitive points of liberation The mind in the body. The second session: Familiarization with the techniques of freeing the mind, using motivational and positive sentences and giving exercises to women. The third session: Rehearsing the taught techniques and the implementation of the technique by the participant will be implemented in this session. The fourth session: Follow-up of training exercises, checking the status of progress. All the trainings will be done face-to-face at the selected two-clinic in Bandar Abbas city and in a private room. Two weeks after the last session, the questionnaires will be completed again.
Category
Lifestyle
2
Description
Control group: Control group: First, after completing the informed consent form, the participants will complete questionnaires on personal-social characteristics, Newton's infertility stress and Connor and Davidson's resilience scale. Then they will only receive routine care. 6 weeks later, the questionnaires will be completed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Hormozgan University of Medical Sciences
Full name of responsible person
Dr. Maryam Azizi
Street address
Fertility and Infertility Health Research Center, First Floor, Shefa Burns and Accidents Building, East Side, Shahid Mohammadi Hospital, Bandar Abbas, Jomohri-e-Islami St.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 0755
Email
hgrc@hums.ac.ir
2
Recruitment center
Name of recruitment center
Dr. Zahra Khashavi infertility clinic
Full name of responsible person
Dr. Zahra Khashavi
Street address
Bandar Abbas, next to Imamzade Seyed Mozafar, in front of Galinos Pharmacy
City
Bandar Abbas
Province
Hormozgan
Postal code
7915753615
Phone
+98 76 3333 3821
Email
drz.khashavi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoume Khairkhah
Street address
Iran University of Medical Sciences, next to Milad Tower, Hammet Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Marzieh Torabi Hefeshjani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
8th floor, unit 84, eastern block, Setara Ya Didas complex, South Elahia town, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7915365168
Phone
+98 76 3437 0206
Email
marziyehtorabi99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoume Khairkhah
Position
Assistant professor of medical education
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Vali Asr St., above Vanak Square, Rashid Yasmi St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shivakheirkhah1345@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marzieh Torabi Hefeshjani
Position
Master's student of midwifery consultation
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 84, 8th floor, Eastern Block, Setara Ya Dedas Complex, South Elahia Town, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7915365168
Phone
+98 76 3437 0206
Email
marziyehtorabi99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD