Effectiveness' determination of psychological interventions on the mental health of women referred to hospital and health centres affiliated to the Kerman University of Medical Science in pregnancy, delivery and the postpartum period in the Coronavirus epidemic in 2020
Design
Empirical intervention-based educational research, With pre-test and post-test, control and intervention groups and simple randomization with a sample size of 60 people
Settings and conduct
The present study is an empirically-based educational intervention with a pretest-posttest and intervention and control group design which will be done by ethic code achieved by Kerman University of Medical Sciences. Women satisfied to participate in the study will be randomly divided into intervention and control groups. The intervention group will attend 6 psychological counselling group sessions through virtual networks such as WhatsApp or Skype for 90 to 120 minutes. The post-test will be offered to the two groups after the sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: satisfaction to participate in the study, being in a time period of 28 weeks of pregnancy to 28th of postpartum day for women referring for postpartum services, not receiving psychiatric medication, not attending in counselling sessions at the same time of study period
Intervention groups
Intervention group: Psychological counselling sessions consists of 6 weekly virtual sessions through virtual networks such as WhatsApp or Skype For 90 to 120 minutes. Control group: There is no intervention.
Main outcome variables
Anxiety, depression, health anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N12
Registration date:2020-12-20, 1399/09/30
Registration timing:retrospective
Last update:2020-12-20, 1399/09/30
Update count:0
Registration date
2020-12-20, 1399/09/30
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-05-10, 1399/02/21
Actual recruitment start date
2020-04-20, 1399/02/01
Actual recruitment end date
2020-05-14, 1399/02/25
Trial completion date
2020-05-14, 1399/02/25
Scientific title
Investigating the effectiveness of tele-counselling on perinatal mental health during SARS-COV-2 pandemics
Public title
Tele-counselling on perinatal mental health during pandemics
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
satisfaction to participate in the study
being in a time period of 28 weeks of pregnancy to 28th postpartum day for women referring for perinatal services
Not consuming psychiatric medication
Exclusion criteria:
loss of pregnancy (fetal death)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study is a simple randomization. It is a personal randomization unit. Layering (strata) is not done. Women under the affiliation of health care centres who fill informed consent forms mean that they agree to participate in the study. for the division of them into two groups of intervention and control, statistical software will usedThe tool used in randomization is Randomizer software (www.randomizer.org) which also performs random sequences. َAllocation concealment does not apply to this counselling intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Education 6 sessions, Twice a week
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-06-19, 1399/03/30
Ethics committee reference number
IR.KMU.REC.1399.134
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
2
Description of health condition studied
depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
3
Description of health condition studied
health anxiety
ICD-10 code
F45.8
ICD-10 code description
Other somatoform disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before and 3 weeks after intervention
Method of measurement
Modified to COVID-19 Hospital Depression and Anxiety Scale
2
Description
Depression
Timepoint
Before and 3 weeks after intervention
Method of measurement
Modified to COVID-19-Hospital Depression and Anxiety Scale
3
Description
health anxiety
Timepoint
Before and 3 weeks after intervention
Method of measurement
Health anxiety questionnnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention consists of 6 weekly group counselling sessions through virtual networks such as WhatsApp or Skype For 90 to 120 minutes Session Content: 1-Training of how to prevent the COVID-19 and provision of information about the disease, familiarity with practical solutions to a healthy lifestyle according to the condition of women (healthy diet, exercise, adequate sleep), dysfunctional cognitions related to COVID-19, muscle relaxation technique, conscious eating technique, assignment 2-Reviewing assignments, defining mindfulness and its benefits in coping with COVID-19 anxiety, training and performing mindfulness on breathing and senses, expressing personal boundaries and limitations, assignments 3-Review of assignments, familiarity with the physical, mental, emotional, and behavioral symptoms of stress and anxiety, introduction of cognitive errors related to COVID-19 from Ellis and Beck's perspectives, training of ways to overcome pregnancy and postpartum fatigue, training of yoga and aerobic exercise to increase respiratory capacity, assignments 4-Review of assignments, seated meditation with focus on breathing, body sounds and thoughts (four-dimensional meditation), definition of autopilot mind, familiarity with coping styles in the face of stressors, assignments. 5-Reviewing assignments, re-discussing cognitive errors, expressing the disadvantages and advantages of worries and fears, promoting family relationships and making love to the fetus and neonate, defining the pleasant and unpleasant life events, and ways to change feelings and attitudes towards events, assignments. 6-Accepting conditions and commitments by relying on self-care, being at the present (quitting daydreaming), discussing one’s fears about one’s vulnerability to disease, doing a body scan, reviewing and concluding.
Category
N/A
2
Description
Control group: There is no intervention for the control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals and health centers care affiliated to Kerman University Medical Science
Full name of responsible person
Atefeh Ahmadi
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5179
Email
atefeahmadi59@gmail.com
2
Recruitment center
Name of recruitment center
Kerman University of Medical Sciences
Full name of responsible person
Sahebeh dadshahi
Street address
Haft bagh, KMU Pardis
City
Kerman
Province
Kerman
Postal code
741
Phone
+98 34 3132 5220
Email
sahebeh68.dadshahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5179
Email
atefeahmadi59@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
2
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahebeh Dadshahi
Street address
Haft Bagh. KMU Pardis
City
Kerman
Province
Kerman
Postal code
741
Phone
+98 34 3132 5180
Email
sahebeh68.dadshahi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor in Kerman University of Medical Sciences, Midwifery Department and Nursing Resea
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5179
Email
atefeahmadi59@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor in Kerman University of Medical Sciences, Midwifery Department and Nursing Resea
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5179
Email
atefeahmadi59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Assistant professor in Kerman University of Medical Sciences, Midwifery Department and Nursing Resea
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Haft Bagh Square
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5179
Email
atefeahmadi59@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