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Investigating the effect of Supportive psycho-educational counseling on the parental distress and well-being among couples expecting their first child

Protocol summary

Study aim
Determining the effect of supportive psycho-educational counseling on the parental distress and well-being among couples expecting their first child
Design
Clinical trial with control and intervention groups, simple randomization, 40 people in the intervention group under counseling, 40 people in the control group.
Settings and conduct
Counseling will be done by the student himself who has been trained in health care centers. For couples in the intervention group, a 90-minute face-to-face counseling session will be held between 26 and 34 weeks of pregnancy, and a part of the counseling will be presented to them in the form of a CD. After the birth of the baby, between 10 and 14 days after delivery, a face-to-face counseling session and then a phone call will be made one week after the second face-to-face session only for the mother. The questionnaires will be completed when the child is two months old.
Participants/Inclusion and exclusion criteria
Entry conditions: gestational age between 26 and 34 weeks, absence of severe pregnancy complications (such as gestational diabetes or preeclampsia), no history of psychological problems and receiving treatment in the 6 months before entering the study, singleton pregnancy, living with a spouse, no Addiction of spouses; Conditions for non-entry: occurrence of severe pregnancy complications and hospitalization, occurrence of premature birth, occurrence and diagnosis of psychological problems in each of the couples and receiving treatment, birth Anomalous baby, hospitalization of the baby after delivery.
Intervention groups
The intervention group will receive two face-to-face sessions of psychoeducational support counseling, two telephone follow-ups and an educational CD. The control group received only routine clinic interventions.
Main outcome variables
supportive psycho-educational counseling; parental distress; parental well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024866N20
Registration date: 2024-06-20, 1403/03/31
Registration timing: prospective

Last update: 2024-06-20, 1403/03/31
Update count: 0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2025-03-10, 1403/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Supportive psycho-educational counseling on the parental distress and well-being among couples expecting their first child
Public title
Effect of Supportive psycho-educational counseling on the parental distress and well-being
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 26 and 34 weeks Absence of severe pregnancy complications (such as gestational diabetes or preeclampsia) No history of psychological problems and receiving treatment in the 6 months before entering the study Singleton pregnancy Living with a spouse Absence of addiction in couples Iranian citizenship Not having a hearing or speaking disorder
Exclusion criteria:
Occurrence of severe pregnancy complications and hospitalization Incidence of premature birth Occurrence and diagnosis of psychological problems in each of the couples and receiving treatment The birth of an abnormal baby Hospitalization of the baby after delivery Suffering from severe complications during and after childbirth of the mother The occurrence of large and unexpected stress during the intervention Absence in any of the considered programs Simultaneously participating in counseling sessions outside the plan
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an accessible and simple random manner, in this way, a list of first-time pregnant women will be taken through the Sib Health system. In order to assign people to two intervention and control groups, a block method and blocks of 4 will be used. So that in each block two people are randomly placed in the intervention group and two people in the control group. Sampling will continue until the size of each group reaches 40 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The intervention group will receive psychoeducational supportive counseling, but the control group will not receive any counseling.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Razi Nursing and Midwifery Faculty; Kerman University of Medical Sciences campus; Haft Bagh Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-04-15, 1403/01/27
Ethics committee reference number
IR.KMU.REC.1403.028

Health conditions studied

1

Description of health condition studied
Parental distress
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Parental well-being
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Parental distress score from modified parenting stress questionnaire, Edinburgh postpartum depression scale and anxiety and depression hospital scale.
Timepoint
Two months after delivery
Method of measurement
Modified parenting stress questionnaire, Edinburgh postpartum depression scale and anxiety and depression hospital scale.

2

Description
Parental well-being score from parental role satisfaction questionnaire and Pittsburgh sleep quality questionnaire
Timepoint
Two months after delivery
Method of measurement
Parental role satisfaction questionnaire and Pittsburgh sleep quality questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For couples in the intervention group between 26 and 34 weeks of pregnancy (depending on when they enter to participate in the study), a 90-minute face-to-face supportive-psychological-educational counseling session was held, and part of the counseling was in the form of an educational clip to A copy of the CD will be presented to them, then a phone call will be made to the expectant mother for prenatal follow-up at 35-36 weeks. After the birth of the baby, between 10 and 14 days after delivery, a 90-minute face-to-face counseling session and then a phone call one week after this face-to-face session, including counseling, training, questions and answers, will be done only for the mother.
Category
Lifestyle

2

Description
Control group: During the period after the birth of the baby, they have access to the routine care of the health center, and at the end of the study, if the intervention is effective, the information is also provided to the control group through an educational CD. At that time, the information is still It can be useful for them.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health service centers of the health deputy
Full name of responsible person
Zahra Raeisi
Street address
Health Deputy, alley next to the Police Command, Takhti Street
City
Sirjan
Province
Kerman
Postal code
7813853444
Phone
+98 34 4228 1611
Email
raeisimidwife@gmail.com
Web page address
http://bankpezeshkan.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy of research and technology; Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
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
Katayoun Alidusti
Position
Instructor of midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery; Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences campus, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidusti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidusti
Position
Instructor of midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery; Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences campus, Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidusti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instuctor of midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery; Razi Faculty of nursing and Midwifery; Kerman University of Medical Scienes campus; Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidusti@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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