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Comparison of the effect of in-home and phone supportive counseling on postpartum depression and anxiety: a randomized controlled clinical trial

Protocol summary

Study aim
Determining and comparing the effect of supportive counseling at home and supportive counseling over the phone on postpartum depression and anxiety
Design
A randomized clinical trial with three parallel arms will be conducted on 93 primiparous women with natural delivery method. The participants will be divided into two intervention groups and a The control group will be allocated.
Settings and conduct
Sampling will be done on women hospitalized in Al-Zahra and Taleghani Medical Education Center in Tabriz, who gave birth the day before; Anxiety and depression scales (10-15 days and 42-60 days after delivery) and maternal quality of life tools (10-15 days after delivery) will be completed by all three groups in Taleghani and Al-Zahra midwifery clinics. The weight at birth and one month old of the baby based on the baby card, the breastfeeding status and the number of visits of the baby will be recorded by the doctor based on the mother's statements in the relevant checklist. The only evaluator of the results will be blind.
Participants/Inclusion and exclusion criteria
Primiparous women who gave birth by natural delivery method, a singleton and full-term baby weighing 2500-4000 grams, no breastfeeding obstacles and contraindications, resident of Tabriz
Intervention groups
In the intervention group, during three supportive counseling sessions at home and telephone supportive counseling, it will be done on days 5-9, 7-3 and 20-25 after delivery, which includes teaching self-care to the mother, breast care, resuming sexual relations. , how to care for the baby, assess stress and teach adaptation skills. The control group will only receive the usual care after delivery.
Main outcome variables
Comparison of the effect of supportive counseling at home and supportive counseling by phone on postpartum depression and anxiety 10-15 days and 42-60 days after delivery will be measured.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170506033834N11
Registration date: 2023-08-20, 1402/05/29
Registration timing: prospective

Last update: 2023-08-20, 1402/05/29
Update count: 0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of in-home and phone supportive counseling on postpartum depression and anxiety: a randomized controlled clinical trial
Public title
Comparison of the effect of in-home and phone supportive counseling on postpartum depression and anxiety: a randomized controlled clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women by vaginal method Having a desire to breastfeed Age 18-45 Living in Tabriz Single birth Mothers with term babies weighing 2500 to 4000 grams
Exclusion criteria:
Mothers with hospitalized babies. Existence of systemic and chronic diseases or aggravating disorders during pregnancy and childbirth, including gestational or overt diabetes, blood pressure disorders, heart disease, and the inability of the mother to care for the baby. Breast anomaly or history of breast surgery The existence of unfortunate events in the last three months, including the death of loved ones, divorce, etc. Obtaining a depression score of 13 or more based on the Edinburgh postpartum depression scale Depressive disorders before pregnancy and delivery according to mother's statement Cases of malformation and infant death Excessive bleeding during childbirth Having breast-feeding contraindications (women undergoing chemotherapy, women with HIV infection, women with untreated active tuberculosis, and the use of radioactive, antimetabolite and illegal drugs during breastfeeding such as methotrexate, mercaptopurine, hydroxyurea, tamoxifen, bromocriptine, Lithium, phenin-dione, phen-cyclidine, cyclophosphamide and doxorubicin, drugs and...
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were divided into two intervention groups (recipients of supportive counseling at home and supportive counseling over the phone) and a control group (recipients of routine care after delivery) will be allocated. For concealment, the type of allocation will be written on paper and placed in numbered opaque envelopes (Allocation Concealment). The envelopes will be opened in order and by a person not involved in sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, according to the nature of the study, it will not be possible to blind the participants and the researcher, and only the evaluator of the results will be a blind person.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commite of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of Medical Sciences, Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.TBZMED.REC.1402.354

Health conditions studied

1

Description of health condition studied
Postpartum
ICD-10 code
Encounter
ICD-10 code description
Z39

Primary outcomes

1

Description
Postpartum Depression
Timepoint
10-15 days and 42-60 days after delivery by controlling the effect of baseline score.
Method of measurement
Edinburgs Postpartum Depression Scale

2

Description
Specific postpartum anxiety
Timepoint
10-15 days and 42-60 days after delivery by controlling the effect of baseline score.
Method of measurement
PSAS-RSF(Postpartum Specific Anxiety Scale Research short-form)

Secondary outcomes

1

Description
Quality of life of mothers
Timepoint
10-15 days after delivery
Method of measurement
MAPP-QOL(Maternal Postpartum Quality)

2

Description
Frequency of exclusive breastfeeding
Timepoint
42-60 days after birth
Method of measurement
A checklist designed to record breastfeeding status

3

Description
Comparison of infant weight
Timepoint
One month after giving birth
Method of measurement
Baby weight card

4

Description
Comparison of the frequency of newborn visits by doctors
Timepoint
42-60 days after birth
Method of measurement
Checklist designed to record the number of baby visits by the doctor

Intervention groups

1

Description
Intervention group: In one of the intervention groups, supportive counseling will be done at home during three sessions on days 5-3 7-9 and 20-25 after delivery for 30-45 minutes .The content of the counseling sessions according to the support counseling protocol will be as follows: The first session (3-5 days after delivery): includes encouraging to talk about the questions and problems that the person has in the process of self-care and caring for the baby and about breastfeeding. Also, criteria of sufficient amount of breast milk, the reasons of infants' crying and refusing to take the breast, nutrition of mothers during breastfeeding, methods to increase breast milk, breast problems, constipation, back pain, care of episiotomy sutures and pain management, and care of the baby's umbilical cord will be explained. The second session (7-9 days after delivery): in this session, in relation to how to store milk and continue breastfeeding, fatigue and the matching of sleeping and waking time with the baby, how the mother interacts with the child, perceived supports, self-care and coping with the responsibilities will be explained. The purpose of this meeting is to recount the person's emotional-emotional reactions to the new situation, and the counselor is looking for performance disturbances, signs such as stress and wrong adaption to explain how to deal with it (teaching relaxation techniques, seeking and attracting social support, improving communication skills with others and especially with husbands). The third session (20-25 days after delivery): in this session, we will talk about the time to resume sexual relations, and contraception methods in breastfeeding mothers and the continuation of breastfeeding. Relaxation techniques will be reviewed and summarized the session details.
Category
Behavior

2

Description
Intervention group: In the other intervention group, phone support counseling will be done in three sessions on days 9-9, 7-3 and 20-25 after delivery for 30-45 minutes. The content of this type of counseling will be the same as home support counseling. If the client needs, one more meeting will be held in each of the groups with prior coordination of the clients. The counseling time will be determined according to the previous agreement with the participants.
Category
Behavior

3

Description
Control group: In this study, the control group will receive only the usual care after delivery.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Bita Eskandari
Street address
Al-Zahra Educational-Therapeutic Center, South Army St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5313644351
Phone
+98 41 5223 3932
Email
bitaeskandari7250@gmail.com

2

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Bita Eskandari
Street address
Taleghani Hospital, Railway Square, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5313644351
Phone
+98 41 5223 3932
Email
bitaeskandari7250@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Central Building, University of Tabriz, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3335 7310
Email
parvizshahabi@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
bita eskandari
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5313644351
Phone
+98 41 3479 6770
Email
bitaeskandari7250@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
Ph.D in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nourizadehr@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
6615615733
Phone
+98 41 3479 0364
Email
nourizadehr@tbzmed.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
No more data
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
No - There is not 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
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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