IRCT | Comparison of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants discharged from the neonatal intensive care unit.

Protocol summary

Study aim: The effect of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants.
Design: This study is a randomized, single-blind, clinical trial including: two intervention groups and one control group, (55 participants in each group).The allocation of the neonates to each group will be randomly assigned by using six-block size.
Settings and conduct: Samples will be mothers of discharged premature infants from the neonatal intensive care unit. Before the intervention, Beck Anxiety questionnaire, Edinburgh Postpartum Depression Inventory, General Health Questionnaire (GHQ), and the Mood States Questionnaire will be completed. In the scheduled and unscheduled kangaroo care groups, special coverage for kangaroo care will be provided to the mothers. From them will be asked to record the number and the duration of this care in a special checklist. In control group, will not used kangaroo care cover. After 1 month intervention, all questionnaires will be completed by all mothers. For blinding, researcher will not be aware about the allocation of groups, also all questionnaires will be gathered by the research assistant who will be unaware of projects aims.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Iranian primiparous women, 18-35 years old. Exclusion criteria: No exclusive breast feeding, Psychological disorders in mother.
Intervention groups: Scheduled kangaroo care: This care will be implemented daily in three shifts: in the morning, afternoon, and evening, each time for 30 minutes. Unscheduled kangaroo care: This care will be performed at any time and according to the mother's desire. It will be taken at least 30 minutes for each skin-to-skin contact between the mother and the baby. control group: Kangaroo care cover will not be used in this group.
Main outcome variables: Anxiety, depression and general health of mother

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20090810002324N19

Registration date: 2022-05-10, 1401/02/20

Registration timing: prospective

Last update: 2022-05-10, 1401/02/20

Update count: 0
Registration date: 2022-05-10, 1401/02/20

Registrant information: Name

Maryam Keshavarz

Name of organization / entity

Iran University of Medical Sciences

Country

Iran (Islamic Republic of)

Phone

+98 21 4365 1813

Email address

keshavarz@iums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-05-19, 1401/02/29
Expected recruitment end date: 2023-03-20, 1401/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants discharged from the neonatal intensive care unit.

Public title: The effect of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants.
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

Iranian primiparous women, age 18-35 year. Wanted and single pregnancy. Gestational age of 32-37 Weeks for neonate. Apgar scores equal or greater than 7 In the 5th minute of neonate birth.

Exclusion criteria:

Psychological disorders ( according to personal reporting ). Chronic disease of mother ( Diabetes / multiple sclerosis / Cardio - vascular disease ). Maternal addiction to cigarettes, alcohol and psychotropic substances ( according to personal reporting ). History of recurrent miscarriage, infertility or infertility treatment. Stressful experiences such as divorce or death of family members in past three months. Congenital anomalies of infants.
Age: From 18 years old to 35 years old
Gender: Female

Phase

N/A

Groups that have been masked

Investigator
Outcome assessor

Sample size

Target sample size: 165

Randomization (investigator's opinion)

Randomized

Randomization description

For one of the two interventions and the control group, will be assigned one of the codes A, B, and C. The allocation of the neonates to each group was randomly assigned by using six-block size. Participants will be placed in one of the two interventions or the control group based on the codes in one of the specified block. For concealment, each block will be placed in an opaque envelope. Each envelope will be randomly selected by a research assistant.

Blinding (investigator's opinion)

Single blinded

Blinding description

Researcher will not be aware about the allocation of groups, also all questionnaires will be gathered by the research assistant who will be unaware of projects aims.

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

School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.

City

Tehran

Province

Tehran

Postal code

1996713883
Approval date: 2022-01-25, 1400/11/05
Ethics committee reference number: IR.IUMS.REC.1400.987

Health conditions studied

1

Description of health condition studied: The mean score of anxiety, depression and general health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: The mean score of mother's anxiety
Timepoint: Before the intervention and after 1 month intervention
Method of measurement: The anxiety of Beck questionnaire

2

Description: The mean score of mother's depression
Timepoint: Before the intervention and after 1 month intervention
Method of measurement: Postpartum Depression of Edinburgh Questionnaire

3

Description: General Health
Timepoint: Before the intervention and after 1 month intervention
Method of measurement: General Health Questionnaire (GHQ)

Secondary outcomes

1

Description: Depressed mood
Timepoint: Before the intervention and then after 1 month intervention
Method of measurement: Depressed mood in the Profile of Mood States Questionnaire (POMS) (McNair)

Intervention groups

1

Description: Intervention group: The scheduled kangaroo care group. This care will be performed daily in three shifts: in the morning, afternoon, and evening, each time for 30 minutes. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper.
Category: Prevention

2

Description: Intervention group: The not scheduled kangaroo care group. This care will be performed at any time and according to the mother's desire. It will take at least 30 minutes for each skin-to-skin contact between the mother and baby. Mothers will be taught how to implement kangaroo care. The baby will be placed in a special kangaroo care cover, vertically between the mother's breasts. Skin-to-skin contact will be made, so the mother's chest will be contacted with the front of the baby's body, and turning the baby's head to the sideways. To maintain a body proper temperature may be used for baby a hat, socks or diaper.
Category: Prevention

3

Description: Control group: Kangaroo care cover will not be used in this group.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Akbar-abadi Hospital

Full name of responsible person

Susan Ahmadi

Street address

Mowlavi st.

City

Tehran

Province

Tehran

Postal code

1168743514

Phone

+98 21 5560 6034

Email

akbarabadihosp@yahoo.com

1

Sponsor: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Dr Kaivani

Street address

Iran University of Medical Sciences, Shahid Hemmat Highway.

City

Tehran

Province

Tehran

Postal code

1449614535

Phone

+98 21 86701

Email

vcm@iums.ac.ir
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

Maryam Keshavarz

Position

Associated professor

Latest degree

Ph.D.

Other areas of specialty/work

Reproductive Health

Street address

School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.

City

Tehran

Province

Tehran

Postal code

1996713883

Phone

+98 21 4365 1813

Email

keshavarz.m@iums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

Maryam Keshavarz

Position

Associated professor

Latest degree

Ph.D.

Other areas of specialty/work

Reproductive Health

Street address

School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.

City

Tehran

Province

Tehran

Postal code

1996713883

Phone

+98 21 4365 1813

Email

keshavarz.m@iums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Iran University of Medical Sciences

Full name of responsible person

soosan Ahmadi

Position

Midwife

Latest degree

Bachelor

Other areas of specialty/work

Midwifery

Street address

School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.

City

Tehran

Province

Tehran

Postal code

1996713883

Phone

+98 21 4365 1000

Email

soosanahmadi75@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

Comparison of two-different time methods of kangaroo care on anxiety, depression, and general health in mothers of premature infants discharged from the neonatal intensive care unit.