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Comparison of the effect of companion and midwife presence during the mother-and-baby skin-to-skin contact on pain and maternal anxiety and neonate physiological indices

Protocol summary

Study aim
Comparison of the effect of companion and midwife presence during SSC on pain and maternal anxiety and neonatal physiological indices
Design
A randomized clinical trial, Randomization using quadratic randomized blocks, sample size= 92
Settings and conduct
This study will be conducted in the maternity ward of AmiralMomenin Hospital in Zabol. In both groups, immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts) and then SSC will begin. This contact will continue for at least one hour.The infant care midwife and the mothers' companion will perform SSC in both control and intervention groups, respectively, while the researcher (midwife) will be present in both groups and will monitor the work process. Neonatal physiological indices, maternal pain, and anxiety will be measured at 30, 60, and 90 minutes after the beginning of SSC.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Natural childbirth, No medical problems and abnormality in the infant Exclusion criteria: Any factor that prevents skin contact.
Intervention groups
In this study, the samples will be equally divided into two groups of maternal and neonatal SSC with a companion (intervention) and midwife (control) presence
Main outcome variables
Infant temperature; Infant HR; SPo2; maternal pain; maternal anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200120046200N2
Registration date: 2020-05-12, 1399/02/23
Registration timing: prospective

Last update: 2020-05-12, 1399/02/23
Update count: 0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
Seyedeh saeedeh Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1807
Email address
mousavi.ss@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of companion and midwife presence during the mother-and-baby skin-to-skin contact on pain and maternal anxiety and neonate physiological indices
Public title
Comparison of the effect of companion and midwife presence during the mother-and-baby skin-to-skin contact
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy and wanted pregnancy Natural delivery Lack of obstetrics complications (such as gestational hypertension, gestational diabetes, prolonged or suspended labor, and fetal distress) No history of maternal medical diseases or mental illnesses Birth weight ≥2500 One minute Apgar score ≥ 7 No medical problem and abnormality in the baby Gestational age ≥ 37 weeks No manual removal of placenta No analgesia during labor No prohibition of breastfeeding Having a lady companion
Exclusion criteria:
Maternal unwillingness to participate in the research Third-or fourth-degree perineal lacerations Postpartum hemorrhage Five minute Apgar score < 7 Anything interrupting skin-to-skin contact
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation for placement in the intervention and control group is done by random block method in four blocks and with allocation software: In this way, by entering the research units in the plan, by referring to the four blocks (letter A belongs to the intervention group and letter B belongs to the control group), the research units are assigned to the intervention and control groups.
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 Iran University of Medical Sciences
Street address
ّّFifth floor, Headquarters., Iran University of Medical Sciences., Hemmat Highway between Chamran and Sheikh Fazlullah
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.IUMS.REC.1398.1364

Health conditions studied

1

Description of health condition studied
Maternal pain and anxiety and assessment of neonatal physiological parameters
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mother's pain
Timepoint
Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Infant temperature
Timepoint
Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact
Method of measurement
Mercury thermometer

3

Description
Infant heart rate
Timepoint
Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact
Method of measurement
Pulse Oximeter device

4

Description
Percentage of oxygen saturation of the infant's blood
Timepoint
Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact
Method of measurement
Pulse Oximeter device

5

Description
Mother's anxiety
Timepoint
Before intervention, 30, 60 and 90 minutes after beginning skin to skin contact
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue at least one hour. In the intervention group, the mother's companion will perform SSC, while the researcher (midwife) will be present and will monitor the work process.The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact.
Category
Rehabilitation

2

Description
Control group: Immediately after birth, the baby will be placed on the maternal abdomen, and dried, and the Apgar scores will be determined. If conditions will be appropriate for the skin-to-skin contact (SSC), the cord will be cut off after 3 minutes, and the head and back should be covered with a warm towel. The infant's axillary temperature, the saturation pressure oxygen (SPo2), and the heart rate (HR) will be measured using a mercury thermometer and a pulse oximeter, respectively. The maternal pain and anxiety will be evaluated on a visual analog scale, then, SSC is uninterrupted, and the baby will be placed on the mom's chest, (Baby's head between breasts), and then SSC will begin. This contact will continue for at least one hour. In this group,a midwife does skin contact. The infant's axillary temperature, blood oxygen saturation percentage, infant heart rate, pain and maternal anxiety will be measured at 30, 60 and 90 minutes after the onset of skin contact.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Amiralmomenin Hospital
Full name of responsible person
Fateme Harati Kabir
Street address
Ali Amiralmomenin Hospital., 3Km; Zabol Road - Zahedan
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3229 5115
Email
amirhospital@zbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Area Two, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 9024 6650
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Saeedeh Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1807
Fax
Email
Saideh.musavi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Saeedeh Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1807
Fax
+98 21 8820 1978
Email
mousavi.ss@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh Saeedeh Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1807
Fax
+98 21 8820 1978
Email
mousavi.ss@iums.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
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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