the effect of multisensory intervention (ATVV) on self-esteem and mental health of mothers of preterm infants.
Design
Study of a clinical trial, non-random allocation with two intervention and control groups, on 60 premature infants
Settings and conduct
In Imam Reza (AS) and Ghaem Mashhad hospitals, in the control group of routine care and in the intervention group, multisensory stimulation was performed and evaluation of maternal mental health and self-esteem in mothers with demographic information questionnaire and Rosenberg self-esteem scale and Glanderberg general health. From the beginning of the intervention, after the intervention, one month later in both intervention and test groups.
Participants/Inclusion and exclusion criteria
Infant admission: 28-32 weeks of age with Apgar score above 7 and no need for resuscitation and no major congenital anomalies and intracerebral hemorrhage and with stable clinical condition Maternal admission: Satisfaction with the study, no mental disorders and drug age Has a history of serious family disputes and is able to be present with the baby.
Intervention groups
In the ATVV (auditory-tactile-visual-vestibular) multisensory intervention group includes: auditory, tactile, visual and atrial stimulation, which is tactile stimulation by the mother after preparing the baby and warming her hands on five areas of the baby's body for 5 minutes. Minutes and to stimulate vision from the mother's direct gaze to the baby and to stimulate hearing the mother's voice is used as a lullaby or the mother speaks directly to the baby
Main outcome variables
Evaluation of mental health and self-esteem in mothers of premature infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210127050152N1
Registration date:2021-02-15, 1399/11/27
Registration timing:prospective
Last update:2021-02-15, 1399/11/27
Update count:0
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
َAzam Neyestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3232 1049
Email address
neyestania911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of performing multisensory intervention (ATVV) by mother on self-esteem and mental health of mothers of preterm infants
Public title
The effect of multisensory intervention (ATVV) on self-esteem and mental health of mothers of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- The age of the baby should be in the range of 28-32 weeks based on the gestational age.
2 - Infants do not have congenital malformations (congenital heart disease, gastrointestinal and neurological defects, etc.)
3. Infants do not need invasive mechanical ventilation (except receiving oxygen with a cannula).
4. No intracerebroventricular hemorrhage (grade 3 and 4)
Stable clinical condition (pink baby color, body temperature 37-36 degrees, oxygen saturation above 90%)
No need for advanced resuscitation during hospitalization
7. Infants with a fifth minute apkard above 7
The mother has the consent to participate in the study.
The mother does not have known mental disorders such as bipolar disorder and severe depression.
According to the mother herself, she should not use drugs.
According to the mother, there should be no serious differences in the family.
The mother should be able to be with the baby.
Exclusion criteria:
Congenital heart disease, gastrointestinal and neurological defects in the infant
The baby needs mechanical ventilation and resuscitation
Existence of cerebral hemorrhage in the infant
Unstable clinical condition
Maternal dissatisfaction with participation in the study
Existence of addiction and history of mental disorders in the mother
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Ethics Committee of Mashhad University of Medical Sciences , fakori blvd , mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2021-01-26, 1399/11/07
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.082
Health conditions studied
1
Description of health condition studied
Conditions arising in the perinatal period|birth|premature (infant)
ICD-10 code
P07.39
ICD-10 code description
Preterm newborn, gestational age 36 completed weeks
Primary outcomes
1
Description
Self-esteem of mothers with premature babies
Timepoint
Before and after the intervention and one month later
Method of measurement
Self-esteem by Rosenberg Self-Esteem Questionnaire
Secondary outcomes
1
Description
Mental health of mothers with premature babies
Timepoint
Before and after the intervention and one month later
Method of measurement
Glanderberg General Health Questionnaire
Intervention groups
1
Description
Intervention group:During the training courses, the researcher learns multisensory stimulation in order to be able to give the necessary training to the mother. The accuracy of the mother's multisensory stimulation in one session is confirmed by the researcher. Multisensory stimulation is performed by the mother for 30 minutes before feeding and twice daily for 5 days. After that, it is recommended to repeat it for up to a month. A weekly follow-up is done to continue the intervention.
Category
Treatment - Other
2
Description
Control group: Routine care (hug care) is performed
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital Mashhad
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Mashhad, Koohsangi St., Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
NeyestaniA911@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Vashani
Street address
Khorasan Razavi, Mashhad, University Street - next to Hoveyzeh Cinema - Ghorashi Building - Research Deputy and
City
Mashhaf
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Vashani
Position
Faculty of Nursing, Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, four doctorates, School of Nursing, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Behnamhr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Vashani
Position
Instructor and faculty member of the School of Nursing, Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad - Ph.D. Crossroads - School of Nursing, Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
behnamhr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Reza Behnam Vashani
Position
Instructor and faculty of the School of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad - Ph.D. Crossroads - School of Nursing, Mashhad University of Medical Sciences
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
behnamnhr@mums.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
There is no more information
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
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