Comparing effect of relaxation and expressive writing intervention on depression, anxiety, stress and success of treatment in infertile women undergoing assisted reproductive technology treatment (ART).
Determining and comparing the effect of relaxation and expressive writing on depression, anxiety, stress and success of treatment of women undergoing assisted reproductive techniques.
Design
andomised, superiority, parallel group trial Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
This study is a randomized clinical trial study in which samples are assigned to three groups of relaxation, written expression and randomized control through 6 blocks. At the beginning of the study, the demographic information form and the DASS-42 questionnaire will be completed by the samples in all three groups. For relaxation intervention, various studies have stated the number of sessions and the duration of relaxation from 12 sessions of 15 to 30 minutes to several sessions of 8 weeks. For written expression intervention, in different studies, the number of sessions and the duration of the intervention were stated as 3 sessions in 3 consecutive days for each session of 20 to 30 minutes. At the end of the follow-up, the success of the treatment will be measured by measuring the BHCG titer.
Participants/Inclusion and exclusion criteria
Age 20-40 years and no use of anti-anxiety and sedative drugs and no previous history of sedation and written expression, no physical, mental problems and medical diseases other than infertility, recorded in the file
Intervention groups
Relaxation and expressive writing groups
Main outcome variables
Infertility treatment success
General information
Reason for update
Acronym
ART
IRCT registration information
IRCT registration number:IRCT20110629006917N5
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of relaxation and expressive writing intervention on depression, anxiety, stress and success of treatment in infertile women undergoing assisted reproductive technology treatment (ART).
Public title
Comparing effect of relaxation and expressive writing intervention on depression, anxiety, stress and success of treatment in infertile women undergoing assisted reproductive technology treatment (ART).
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- Being of Iranian origin
Literacy
Being in the age range of 40-20 years
Candidate for IVF and ICSI treatment
Access and ability to use social networks such as WhatsApp
Exclusion criteria:
Uterine and endometriosis causes of infertility
anti-anxiety and sedative drugs use
previous history of relaxation and expressive writtijng
PGD candidate
having an adopted child
physical, mental or medical problems other than infertility that recorded in the file-
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:
90
More than 1 sample in each individual
Number of samples in each individual:
12
In this study, theparticipants are infertile woman who refer to the infertility clinic of Shahid Akbarabadi (infertility confirmation was done by a gynecologist and is recorded in the patient file) are eligible for study and have including criteria
Randomization (investigator's opinion)
Randomized
Randomization description
The sample size of the present study, which is 90, will be done through blocking. To form a block, an equal number is assigned to each group so that the block reaches the desired size. List of all possible blocks with size 6 (multiplier of the number of study groups) using MATLAB and Excel software, duplicate blocks are removed and then assigned to the blocks, numbers 1 to 90 according to the total volume of moisture, which is 90's. And using a random table of numbers, 15 blocks of 6 are selected. Entry into each of the groups of relaxation, expressive writting and control (assignment of names A, B, C to the groups is also done randomly) is done by selective blocks and arrangement inside the block, respectively.
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
Iran University of Medical Sciences (Biomedical Research Ethics Committee)
Street address
Hemmat Highway, next to Milad towel, IUMS
City
Tehran
Province
Tehran
Postal code
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.IUMS.REC.1399.716
Health conditions studied
1
Description of health condition studied
FemaleInfertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Treatment Success
Timepoint
Days of 0, Puncture and a day before pregnancy test
Method of measurement
Questionnaires
Secondary outcomes
1
Description
no
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Benson Relaxation
Category
Rehabilitation
2
Description
Intervention group: Expressive writing
Category
Rehabilitation
3
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar-Abadi Hospital
Full name of responsible person
Zahra Najd Gholami
Street address
Molavi Ave, Before Molavi Cross, Bagh Ferdose Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Zahra Najd Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
zahrang43@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
amini.l@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Najd Gholami
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
zahrang43@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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available