Determining the effect of first skin contact between fathers and premature infants admitted to neonatal intensive care unit on their anxiety
Design
At first, 72 eligible fathers of neonates were selected and randomly divided into intervention and control groups (n = 36). It was measured and assessed with previous anxiety levels.
Settings and conduct
Selection of fathers with infants admitted to the NICU based on inclusion criteria, explaining the study description and conditions for all individuals and receiving written consent to attend the study, assessing the anxiety of fathers before the intervention using the Spielberger questionnaire, then selecting The two groups were randomized and skin-to-skin contact was performed for the intervention group in a separate room by the trained nurse controlling the physiological stability of the infant and the usual meeting conditions. for the control group and re-examining the fathers' anxiety immediately after.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Calendar age of baby (between 2 to 5 days)
2. The baby with physiological stability conditions
3. Fetal age under 37 weeks
4. Absence of nicotine or caffeine by the father one hour before the start of the study
Exclusion criteria
1. Infant receiving oxygen or respiratory distress
2. The father of a drug user
3. drug-using mothers
4. Infants with congenital disease
5. Previous baby hospitalization history
6. Recent adverse conditions
7. Psychological problems of the father
Intervention groups
1: Intervention group: 36 fathers with premature infants admitted
Creating and establishing skin contact of a premature infant with their fathers sitting for half an hour
2: Control group: 36 fathers with premature infants admitted
Routine appointments, in this group skin contact with fathers is not established
Main outcome variables
Fathers' anxiety level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200107046040N1
Registration date:2020-12-14, 1399/09/24
Registration timing:retrospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Aliasghar Panabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 8608
Email address
aliasghar.panabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-27, 1398/12/08
Expected recruitment end date
2020-06-15, 1399/03/26
Actual recruitment start date
2020-02-27, 1398/12/08
Actual recruitment end date
2020-06-15, 1399/03/26
Trial completion date
2020-06-15, 1399/03/26
Scientific title
Evaluation of the first skin contact father with their preterm infants admitted to Neonatal Intensive Care Unit (NICU) ward
Public title
Evaluation of the first skin contact father with their preterm infants admitted to Neonatal Intensive Care Unit (NICU) ward of Shohada Kargar Hospital on their anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Calendar age (2 to 5 days)
The baby has physiologically stable conditions
Fetal age under 37 weeks
Absence of nicotine or caffeine by the father one hour before enrollment (due to the possible effect of these substances on anxiety)
Exclusion criteria:
Age
From 2 days old to 5 days old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were divided into test and control groups in pairs and individually (one in between), so that the first infant was divided into the experimental group and the second infant into the control group, and so on.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, a trained research colleague was used to make skin contact and the researcher did not know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd Imam Shahr Kargar Blvd. North Sajjad St. Alley 16 corner of Ayatollah Sadr
City
Yazd
Province
Yazd
Postal code
8917777494
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.SSU.REC.1398.239
Health conditions studied
1
Description of health condition studied
Skin-to-skin contact
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fathers Anxiety Level
Timepoint
At the beginning of the study before the intervention and immediately after the intervention in both groups
Method of measurement
The level of anxiety in the experimental and control groups before and after the intervention was determined using the Spielberger Anxiety Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After introducing and presenting the necessary explanations about the goals and methods of research and ensuring the confidentiality of information, written and informed consent was received in two copies. . Then, before starting the intervention, the individuals completed the Spielberger STAI form of the situational anxiety-trait questionnaire and the demographic profile form (the infant profile was completed by the researcher from the patient file). ). For 30 minutes (based on similar studies) they were exposed to skin-to-skin contact with infants who had stable conditions according to inclusion criteria. In this way, the naked baby was placed on the skin of the father's abdomen, which in this type of contact, no face-to-face communication was established between the father and the baby and only brought the benefits of skin-to-skin contact. The time of sampling and intervention was between 11 and 17 o'clock. During the skin contact of the baby, the nurse was present to control the baby's symptoms by observation. The parameters of blood oxygen saturation, heart rate, respiration rate are monitored by the nurse. Immediately after skin-to-skin contact, the questionnaire was completed again by individuals.
Category
Behavior
2
Description
Control group: Control group: After introducing and presenting the necessary explanations about the goals and methods of the research and ensuring the confidentiality of the information, written and informed consent was received in two copies. Then, before beginning the intervention, individuals completed the Spielberger STAI Formal-Characteristic Anxiety Questionnaire and the Demographic Characteristics Form (the infant profile was completed by the researcher from the patient's record). Minutes in this group, no skin contact with fathers. Immediately after leaving, the questionnaire was completed again by individuals.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Kargar Hospital
Full name of responsible person
Ali Asghsar Panabadi
Street address
Yazd - Ayatollah Modarres Boulevard
City
Yazd
Province
Yazd
Postal code
٣٨٢٥٠٠٠٧
Phone
+98 35 3182 2000
Email
shohadakargar.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Yazd, Bahonar Square, the headquarters of Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, third floor
City
yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Email
ayazi.pajoohan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
khadijeh dehghani
Position
Faculty member of the nursing department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh dehghani
Position
Faculty member of the nursing department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh dehghani
Position
Faculty member of the nursing department
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yazd - Safaieh - Timsar Fallahi St. - Bouali Alley School of Midwifery Nursing
City
yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
dehghanish@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
...
When the data will become available and for how long
Access period starts from 1399
To whom data/document is available
It will be available to researchers working in academic and scientific institutions and to people working in industry.
Under which criteria data/document could be used
...
From where data/document is obtainable
...
What processes are involved for a request to access data/document