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The effect of counseling with stress management approach on anxiety and distress and breastfeeding self-efficacy in Corona pandemic: a clinical randomized controlled trial

Protocol summary

Study aim
Determining the effect of counseling with stress management approach on anxiety and distress and self-efficacy of lactating women in corona pandemic
Design
A randomized clinical trial with two parallel arms will be performed on 64 lactating women (first and second deliveries) who have given birth in the last month. Participants using RAS software in blocks of 4 and 6 with a ratio of 1: 1 will be assigned to two groups and will be followed up 4 weeks after the intervention.
Settings and conduct
Sampling will be performed on lactating women (first and second delivery) who have given birth in the last month and their details are available in Tabriz health centers. Participants will be assigned to two groups by random blocking. Anxiety, postpartum distress and breastfeeding self-efficacy questionnaires will be completed by both groups before the intervention and 4 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: first and second delivery and lactation (delivery in a recent month) and anxiety score 43 to 53, no hospitalization of the child and no unsolvable breastfeeding problem
Intervention groups
In the intervention group, counseling will be done in 6 sessions of 60 to 90 minutes individually in the health center, during which techniques such as relaxation, diaphragmatic breathing, identification of negative thoughts and reconstruction of those thoughts by replacing logical thoughts, effective coping training and expression skills are used. For the control group, a counseling session on contraceptive methods will be held for an average of 60-90 minutes.
Main outcome variables
Comparison of Anxiety Score, Postpartum Distress, and Breastfeeding Self-Efficacy 4 weeks after the intervention, the Spielberger Anxiety, Postpartum Distress, and Breastfeeding Self-efficacy questionnaires will be measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171007036615N6
Registration date: 2021-09-15, 1400/06/24
Registration timing: prospective

Last update: 2021-09-15, 1400/06/24
Update count: 0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-01-30, 1400/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with stress management approach on anxiety and distress and breastfeeding self-efficacy in Corona pandemic: a clinical randomized controlled trial
Public title
The effect of counseling with stress management approach on anxiety and distress and breastfeeding self-efficacy in Corona pandemic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First and second delivery and lactation (delivery in a recent month) Anxiety score 43 to 53 Having a contact number to follow Literacy
Exclusion criteria:
Uncertainty about being able to attend all counseling sessions The child is hospitalized Insoluble breastfeeding problem Achieve an anxiety score above 53 Distress score above the average of the total score
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the two groups receiving the intervention and control through simple random blocking using RAS software with 4 and 6 blocks with a ratio of 1: 1. The allocation type will be written on paper and numbered in a series of opaque envelopes (Allocation concealment). The envelopes will be opened in the order in which the participants enter the study.
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 Tabriz University of Medical Sciences
Street address
Azadi St., South Shariati, School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
0415138947
Approval date
2021-02-22, 1399/12/04
Ethics committee reference number
IR.TBZMED.REC.1399.1078

Health conditions studied

1

Description of health condition studied
Anxiety postpartum
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

2

Description of health condition studied
distress in postpartum (after delivery)
ICD-10 code
O75.0
ICD-10 code description
Maternal distress during labor and delivery

Primary outcomes

1

Description
Anxiety score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Spielberger Anxiety Questionnaire (Manifest Anxiety Scale)

2

Description
Postpartum distress score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Postpartum Distress Questionnaire

3

Description
Breastfeeding self-efficacy score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Breastfeeding self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, during 6 sessions of 60 to 90 minutes of individual counseling, the stress management approach, which includes techniques such as relaxation, diaphragmatic breathing, meditation, recognizing negative automatic thoughts and reconstructing those thoughts by replacing logical thoughts, effective coping training and the skill of assertiveness, is applied.
Category
Behavior

2

Description
Control group: For the control group, a counseling session on contraceptive methods will be held for an average of 60-90 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mojahedin
Full name of responsible person
Shiva Shamsedanesh
Street address
Mofatteh St -Shahid Imam Doost St
City
Tabriz
Province
East Azarbaijan
Postal code
5145797613
Phone
+98 41 3233 5950
Email
shiva.shams92@gmail.com

2

Recruitment center
Name of recruitment center
Sayyad Shirazii
Full name of responsible person
Shiva Shamsedanesh
Street address
Pasdaran St -Oposite Maleki shops
City
Tabriz
Province
East Azarbaijan
Postal code
5147743813
Phone
+98 41 2352 3421
Email
shiva.shams92@gmail.com

3

Recruitment center
Name of recruitment center
Shahid Babayi
Full name of responsible person
Shiva Shamsedanesh
Street address
Flight City Parvaz-Opposite The Polis Park
City
Tabriz
Province
East Azarbaijan
Postal code
5167753561
Phone
+98 41 3385 1115
Email
shiva.shams92@gmail.com

4

Recruitment center
Name of recruitment center
Molla Hasan
Full name of responsible person
Shiva Shamsedanesh
Street address
Molla Hasan -The End Of Segatoleslam St
City
Tabriz
Province
East Azarbaijan
Postal code
5138984969
Phone
+98 41 3555 5301
Email
shiva.shams92@gmail.com

5

Recruitment center
Name of recruitment center
Qom Tape
Full name of responsible person
Shiva Shamsedanesh
Street address
Shahid Garebaghi St- Yeke Dokan
City
Tabriz
Province
East Azarbaijan
Postal code
5146967155
Phone
+98 41 3235 7615
Email
shiva.shams92@gmail.com

6

Recruitment center
Name of recruitment center
Imamieh
Full name of responsible person
Shiva Shamsedanesh
Street address
Mearaj St-Hakim Nezami St
City
Tabriz
Province
East Azarbaijan
Postal code
5164843918
Phone
+98 41 3541 9330
Email
shiva.shams92@gmail.com

7

Recruitment center
Name of recruitment center
Sardrood2
Full name of responsible person
Shiva Shamsedanesh
Street address
First Street of Seyyed Ahmad
City
Tabriz
Province
East Azarbaijan
Postal code
5361765794
Phone
+98 41 3420 2400
Email
shiva.shams92@gmail.com

8

Recruitment center
Name of recruitment center
Eram Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
AL- Mahdi-Area 8-Township Eram
City
Tabriz
Province
East Azarbaijan
Postal code
5145858356
Phone
+98 41 4948 3230
Email
shiva.shams92@gmail.com

9

Recruitment center
Name of recruitment center
Gods Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
Opposite the Bank-Not reached the Akhuni crossrod-Al-Gods St.
City
Tabriz
Province
East Azarbaijan
Postal code
5183763673
Phone
+98 41 3444 0592
Email
shiva.shams92@gmail.com

10

Recruitment center
Name of recruitment center
Shafee Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
First Shadegan-Akhuni St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 6333 3288
Email
shiva.shams92@gmail.com

11

Recruitment center
Name of recruitment center
Sadeghi nezhad Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
Moallem Blvd-Hojjati St.
City
Tabriz
Province
East Azarbaijan
Postal code
5186943111
Phone
+98 41 2585 3288
Email
shiva.shams92@gmail.com

12

Recruitment center
Name of recruitment center
Jamshi Abad Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
East Feizaye-Hojjati St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 8035 3280
Email
shiva.shams92@gmail.com

13

Recruitment center
Name of recruitment center
Safa Helth Center
Full name of responsible person
Shiva Shamsedanesh
Street address
Next to the gas bomber-Better than Maralan's Way-Shahid jodeyri St-Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5163937966
Phone
+98 41 3334 0444
Email
shiva.shams92@gmail.com

14

Recruitment center
Name of recruitment center
Monajjem Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
Staition Naser-Monajjem St.
City
Tabriz
Province
East Azarbaijan
Postal code
5185757385
Phone
+98 41 3282 8428
Email
shiva.shams92@gmail.com

15

Recruitment center
Name of recruitment center
Shahid sharbati zade Health Center
Full name of responsible person
Shiva Shamsedanesh
Street address
Engelab St-Engelab square-Eram
City
Tabriz
Province
East Azarbaijan
Postal code
5145858356
Phone
+98 41 3234 0001
Email
shiva.shams92@gmail.com

16

Recruitment center
Name of recruitment center
Azadi
Full name of responsible person
Shiva Shamsedanesh
Street address
Telecom staition-Mofatteh
City
Tabriz
Province
East Azarbaijan
Postal code
5144813111
Phone
+98 41 3233 4199
Email
shiva.shams92@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Golgasht St., Tabriz University, Central Building
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3335 7310
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shiva Shamsedanesh
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Azadi St., South Shariati, Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
shiva.shams92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.Din Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Street South Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.Din Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Azadi St., South Shariati, Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.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
There is no more information.
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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