Determining the effect of emotional disclosure on depression, anxiety and stress and quality of life in women after abortion
Design
Two arm parallel group randomized trial, on 70 women. A random sequence generated using www.randomization.com was used for randomization.
Settings and conduct
Women who have been admitted to the gynecology wards of Birjand hospitals for a spontaneous abortion within the last 48 hours and are eligible for inclusion in the study will be easily selected.In the intervention group, after teaching the emotional disclosure method, they do it both in writing and orally.
Participants/Inclusion and exclusion criteria
Iranian women aged 18-45 who have been hospitalized in women's wards for the past 48 hours following a spontaneous abortion
Intervention groups
In the intervention group, in addition to the usual hospital training and medical care, during one session, the method of individual emotional disclosure and face-to-face, in the hospital, is fully taught by the researcher in an explanatory manner and they are asked to do 1± 4 sessions for 15 - 20 minutes for 2 consecutive weeks (1± 2 sessions per week) in a secluded and convenient place at home, write their deepest negative feelings and emotions freely and fluently on the reminder sheets. At the end of each week, a verbal exposure session (two sessions in total) will be conducted by the researcher making a telephone call to them and the researcher will listen to them for 15-20 minutes.
The control group receives only routine training and care.
Main outcome variables
depression, anxiety and stress and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210528051421N1
Registration date:2021-06-29, 1400/04/08
Registration timing:registered_while_recruiting
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Maleknaz Ghannadkafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3244 0350
Email address
nkafi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Emotional Disclosure on Depression, Anxiety and Stress and Quality of Life in Women after Abortion
Public title
The Effectiveness of Emotional Disclosure on Depression, Anxiety and Stress and Quality of Life in Women after Abortion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-Women who have had a miscarriage within 48-24 hours.
2- Will be willing to participate in the study and complete the informed consent form.
3- Be a Muslim and an Iranian.
4- To be 18-45 years old.
5- Pregnancy is the desire of the couple.
6- Does not have chronic physical diseases.
7 - Do not have a disability.
8- Has no other psychological disorders.
9- Be literate.
10- Do not have major stressful events in the last 6 months.
11- Has not taken sedatives and psychotropic drugs in the last 6 months.
12- Not addicted to drugs, tobacco and alcohol.
13- Have a spouse and live with his.
14- Has no history of infertility.
15- Depression score between 10-20 (mild and moderate depression) has been obtained from the Depression, Anxiety and Stress Questionnaire 21-DASS.
16- Anxiety score higher than 7 (mild anxiety up) has been obtained from the Depression, Anxiety and Stress Questionnaire 21-DASS.
17- Stress score higher than 14 (mild stress upwards) has obtained from the Depression, Anxiety and Stress Questionnaire 21-DASS.
Exclusion criteria:
Unable to write, speak or listen.
Have severe physical complications from abortion.
Do not have access to a mobile phone.
Be pregnant with assisted reproductive techniques.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is a simple individual randomization that using random sequence generated by www.randomization.com, individuals in the group are divided into two groups of intervention and control.
In this way, the generated random sequence is written on small sheets and kept in a closed envelope, and when each person is selected, the envelope door is opened and she enters each group according to the code (A and B).
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
Ethics committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery
Street address
Chaharah Doktora Crossing, Ibn-e Sina St, Mashhad Faculty of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.093
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Depression score in Anxiety, Stress, Depression Questionnaire (DASS -21)
Timepoint
Before the intervention, end of the intervention and one month after the intervention
Method of measurement
Anxiety, stress, depression questionnaire ( DASS -21)
2
Description
Anxiety score in Anxiety, Stress, Depression Questionnaire (DASS -21)
Timepoint
Before the intervention, end of the intervention and one month after the intervention
Method of measurement
Anxiety, stress, depression questionnaire ( DASS -21)
3
Description
Stress score in Anxiety, Stress, Depression Questionnaire (DASS -21)
Timepoint
Before the intervention, end of the intervention and one month after the intervention
Method of measurement
Anxiety, stress, depression questionnaire ( DASS -21)
4
Description
Quality of life score in the World Health Organization quality of life questionnaire
Timepoint
Before the intervention, end of the intervention and one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire - Short Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: emotional disclosure. In this group, in addition to the usual medical care of the hospital, during an individual session, in an explanatory manner and face to face, emotional disclosure (written and spoken) is taught to women after spontaneous abortion. Then, they are asked to freely express their deepest negative feelings and emotions for 1 ±4 sessions, each time for 15-20 minutes for 2 consecutive weeks (2 ±1 sessions per week) in a secluded and completely quiet and comfortable place at home. And write fluently on reminder sheets. They are told to free their minds and focus entirely on the writing experience. When writing, do not worry about spelling words or structural rules of sentences and the spatial and temporal order of events, and continue writing until the end of time. At the end of each week, an oral disclosure session (two sessions in total) will be conducted by telephone with them for 15-20 minutes.
Category
Rehabilitation
2
Description
Control group: They receive medical education and care, including control of vital signs and vaginal bleeding until they stabilize after an abortion and receive medication.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Birjand
Full name of responsible person
Maleknaz Ghannadkafi
Street address
Valiasr Hospital, Ghaffari Ave., Birjand
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۹۶۴۱۵۱
Phone
+98 56 3244 0350
Email
nkafi@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences , Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maleknaz Ghannadkafi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Chaharah Doktora Crossing, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 3859 1511-3
Fax
+98 51 3859 7313
Email
nkafi@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
Tutor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Chaharah Doktora Crossing
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 38591511-3
Email
Mirzakhanik@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maleknaz Ghannadkafi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Nursing & MIdwifery, Birjand University of Medical Sciences , Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0350
Email
nkafi@bums.ac.ir
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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available