Protocol summary

Study aim
Determining the effect of written expression on depression, stress, anxiety and quality of life of infertile women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
Participants will complete the demographic information questionnaire, DASS-21 and World Health Organization quality of life questionnaire on the first day of menstruation at the Milad infertility center. In the second week and at the time of the start of the Don Regulation, the participants have to do daily written assignments. Three weeks after the last writing session, participants will complete the DASS-21 questionnaire. Finally, 6 weeks after completing the intervention (in the 8th week after starting the treatment) and before the pregnancy test, the participants will complete the DASS-21 questionnaire and the quality of life.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least two years of infertility history, primary or secondary infertility for any reason, undergoing IVF or ICSI treatment, being Iranian and living in Mashhad, age range 18-40 years. Exclusion criteria: Having a previous mental illness, experiencing a stressful event in the last three months, suffering from depression, stress and severe anxiety, a candidate for genetic diagnosis before implantation, a candidate for using donation methods, participating in a similar study in a previous IVF cycle, addiction to Tobacco and alcohol
Intervention groups
The intervention method consists of three 20-minute written assignments that are carried out in a 3-days period. The intervention group writes about involuntary childlessness and infertility treatment, and the control group writes about their daily activities.
Main outcome variables
Depression, stress, anxiety, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221108056434N1
Registration date: 2022-12-27, 1401/10/06
Registration timing: prospective

Last update: 2022-12-27, 1401/10/06
Update count: 0
Registration date
2022-12-27, 1401/10/06
Registrant information
Name
Samira Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4224 9520
Email address
samiranasri12275@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing intervention (EWI) on depression, stress, anxiety and quality of life of infertile women
Public title
he effect of written expression on infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least two years of infertility history At least middle school education Being the husband's only wife Living with a spouse Primary or secondary infertility of any cause Women undergoing IVF or ICSI treatment Being Iranian and living in the city of Mashhad Age range 18-40 years
Exclusion criteria:
Existence of previous mental illness Experiencing a stressful event in the past three months Suffering from severe depression, stress and anxiety candidate for pre-implantation genetic diagnosis (PGD) Candidate for using donated egg, donated embryo and surrogate uterus Participation in the same study in the previous IVF cycle Smoking and alcohol addiction
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples to each of the 2 intervention and control groups, blocks of 4 variables are used. In this way, six possible states of blocks (BBAA, BABA, ABBA, BAAB, AABB, ABAB) are listed and a number from one to six is assigned to each block. Then randomly and through lottery, a number between one and six is selected and then people are assigned to the test (B) and control (A) groups based on the block corresponding to the selected number. This work continues until the sample volume is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the intervention and control groups participate in a writing intervention, but they are not aware of the content of the written expression of the other group, and only the researchers themselves were aware of the content recommended for writing, and the participants and the data analyst were not.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Side of the Asian Road - Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2022-10-09, 1401/07/17
Ethics committee reference number
IR.GMU.REC.1401.085

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

2

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

3

Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
depression
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Dass-21 questionnaire

2

Description
stress
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Dass-21 questionnaire

3

Description
Anxiety
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Dass-21 questionnaire

4

Description
Quality of life
Timepoint
Before the intervention, 6 weeks after the intervention
Method of measurement
WHOQOL-BREF questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention consists of three written assignments for 20 minutes that are carried out in a period of 3 days. The intervention group is taught to write about involuntary infertility and IVF/ICSI treatment for infertility.
Category
Behavior

2

Description
Control group: The intervention consists of three written assignments for 20 minutes that are carried out in a period of 3 days. The control group is instructed to write about their daily activities for the previous day, the last five days, and finally the planned activities for the next five days.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital - Milad Infertility Center of Mashhad
Full name of responsible person
Smira Nasri
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
samiranasri12275@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Leila Sadeghi Moghadam
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
ls_moghadam@yahoo.com
Web page address
http://res.gmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Hadizadeh goldsmith
Position
Associate professor of reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
shahnazhadizadeh@yahoo.com
Web page address
http://isid.research.ac.ir/Fatemeh_HadizadehTalasaz

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Hadizadeh goldsmith
Position
Associate professor of reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
shahnazhadizadeh@yahoo.com
Web page address
http://isid.research.ac.ir/Fatemeh_HadizadehTalasaz

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Samira Nasri
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
On the side of Asian Road, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 3814
Email
samiranasri12275@gmail.com
Web page address
http://www.gmu.ac.ir/

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
The information of the contributors is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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