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The effect of expressive writing on depression, anxiety, stress ,and sleep quality of infertile women

Protocol summary

Study aim
The effect of expressive writing on depression, anxiety, stress and sleep quality of infertile women referring to Isfahan Infertility Clinics in 2021
Design
Randomized controlled clinical trial on 102 participants ( intervention group 51 and control group 51) and random allocation using opaque sealed packages.
Settings and conduct
Out of infertile women referring to Isfahan Infertility Center and Maryam Infertility Center the volunteer ones with inclusion criteria, obtaining a score of anxiety and depression above 10 from DASS-21 questionnaire, and a score above 5 from the Pittsburgh questionnaire will be entered. After random allocation to control or intervention group, depression, anxiety, stress, and sleep quality will be measured.Then the method of writing will be instructed to the participants of two groups. Just after 3 day intervention, the variables will be measured again.
Participants/Inclusion and exclusion criteria
Willing to participate in the study, Diagnosed infertility, Candidate for assisted reproductive therapy, Married, Age of 18- 45 years, Anxiety and depression, Scores above 10 and sleep quality scores above 5, Having a high school diploma or higher education, Not participating simultaneously in other research related to the treatment of anxiety/depression/sleep disorders, Not referring to a psychologist or psychiatrist during study
Intervention groups
Intervention group: In this group, samples are taught to write down their deepest feelings, worries, and thoughts about not having a child and worries related to infertility methods for 3 days, every day for 20 minutes at home. Control group: In this group, they are asked to write for 20 minutes every day for 3 days about daily events that do not involve their emotions and feelings, such as cleaning, cooking, etc.
Main outcome variables
Depression; anxiety; stress; sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091001002531N6
Registration date: 2022-02-01, 1400/11/12
Registration timing: prospective

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-03, 1400/11/14
Expected recruitment end date
2022-05-09, 1401/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing on depression, anxiety, stress ,and sleep quality of infertile women
Public title
The effect of expressive writing on depression, anxiety, stress, and sleep quality of infertile women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Diagnosed infertility Candidate for assisted reproductive therapy Married Anxiety and depression scores above 10 and sleep quality score above 5 Age of 18 - 45 years Having high school diploma or higher education
Exclusion criteria:
Infertile women candidate for surrogacy or ovule donation Infertile women with severe anxiety and depression scores Infertile women referring to a psychologist or psychiatrist during study Infertile women participating simultaneously in other researches related to the treatment of anxiety, depression, stress, and sleep disorders
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will ask the participants to take a sealed opaque package out of 102 randomly. 51 packages contain questionnaires and checklists coded 1(related to intervention group: express writing) and 51 packages contain the same questionnaires and checklists coded 2(related to control group: neutral writing). This process will continue until having 51 samples in both groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The questionnaires have code 1 or 2.The data analyzer will will not know which number relates to which group (control or intervention)
Placebo
Not used
Assignment
Parallel
Other design features
In this study, infertile women are divided into two groups of control and intervention, so two groups will be assessed.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.198

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

2

Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders

3

Description of health condition studied
Quality of sleep
ICD-10 code
F51.12
ICD-10 code description
Insufficient sleep syndrome

4

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Depression
Timepoint
Before expressive writing , Immediately after expressive writing, and 2 weeks after expressive writing.
Method of measurement
Using Depression questionnaire DASS-21

2

Description
Anxiety
Timepoint
Before expressive writing , Immediately after expressive writing, and 2 weeks after expressive writing.
Method of measurement
Using Anxiety questionnaire DASS-21

3

Description
Stress
Timepoint
Before expressive writing , Immediately after expressive writing, and 2 weeks after expressive writing.
Method of measurement
Using Stress questionnaire DASS-21

4

Description
Quality of sleep
Timepoint
Before expressive writing , Immediately after expressive writing, and 2 weeks after expressive writing.
Method of measurement
Using Sleep quality questionnaire of Pittsburg

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, participants are taught to write for 3 days, every day for 20 minutes , their deepest feelings and worries and thoughts about not having a child and worries related to infertility methods. When writing, write down every word or phrase that comes to mind and do not worry about the correctness or politeness of the words and sentences, that's mean the correct spelling or spelling of the words does not matter at all and the words should be used that express their true feelings and she will be asked to write, for example, about a disturbing event in order to fix the problem.
Category
Treatment - Other

2

Description
Control group: In this group. the participants are asked to write down about everyday events that do not involve their emotions and feelings, such as cleaning, cooking... for 20 minutes every day for 3 days .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Infertility Center
Full name of responsible person
Fatemeh Sadeghi Dousari
Street address
Corner of Behesht St., Salman Farsi St. (Mustaq II), Bozorgmehr Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8158858151
Phone
+98 31 3267 0030
Email
info@isf-ific.com
Web page address

2

Recruitment center
Name of recruitment center
Maryam Infertility Center
Full name of responsible person
Fatemeh sadeghi dousari
Street address
Metal Bridge, the beginning of Motahhari , Isfahan
City
Isfahan
Province
Isfehan
Postal code
8184851153
Phone
+98 31 3236 7001
Email
Fatemehsadeghi0074@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Mansoor Siavash
Street address
The deputy of research and technology, building 4, Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3335 9933
Email
emrc@mui.ac.ir
Web page address
https://isid.research.ac.ir/Mansoor_SiavashDastjerdi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of midwifery and reproductive health, Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery and Reproductive Health, Faculty of Nursing & Midwifery, Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhahtehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of midwifery and reproductive health, Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@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
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