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Trial registered on ANZCTR


Registration number
ACTRN12617000449336
Ethics application status
Approved
Date submitted
4/02/2017
Date registered
27/03/2017
Date last updated
16/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcomes of early auditory, tactile, visual and vestibular (ATVV) stimulation in the adaptation to birth of the mother and child dyad
Scientific title
Effect of multisensory stimulation auditory, tactile, visual and vestibular (ATVV) in the adaptation to the birth of the mother and child dyad
Secondary ID [1] 291051 0
'Nil known'
Universal Trial Number (UTN)
U1111-1192-3774
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postpartum depression 301841 0
Ineffective breastfeeding 301845 0
Condition category
Condition code
Reproductive Health and Childbirth 301522 301522 0 0
Breast feeding
Reproductive Health and Childbirth 301907 301907 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Early stimulation of the newborn. The technique of auditory, tactile, visual and vestibular multi-sensory stimulation (VCTA) is used.
2. This therapy performs the hearing of the stimulus with the voice of the mother, the touch of the stimulus with the realization of an ordered and sequential massage; Visual stimulation with visual contact with his mother and vestibular stimulation with slow movements in the arms of the mother
3. ATVV therapy is performed according to the Rice Protocol modified by White-Traut and Contributors and lasts for 15 minutes.
4. Mothers received training in therapy by a nurse. A video was used to do the demonstration of each stimulation and neonatal behavioral responses showing pleasure with the stimulus. The video lasted 6 minutes. Then a recording gives continuous instructions to the mother step by step during the performance of the stimulation therapy
5. During the first application an understanding checklist is made
6. To promote adhesion, the mother is given a headset set with recorded instructions
7. At home, mothers performed therapy by listening to recorded instructions, twice a day for 7 days
Intervention code [1] 297039 0
Treatment: Other
Comparator / control treatment
Control group
The standard of care involves advice from nurses on doubts that the mother in the first 24 to 36 hours of hospital stay. A medical assessment by the gynecologist in the first 10 days postpartum and an assessment made of Pediatrics between 30 and 40 of the life of the newborn
Control group
Active

Outcomes
Primary outcome [1] 300956 0
depression postpartum whith EPDS scale or Edinburg Postpartum Depression Scale
Timepoint [1] 300956 0
Six weeks post birth.
Primary outcome [2] 300957 0
stress for motherhood
Measured with Being to Mother BaM-13 version in Spanish
Timepoint [2] 300957 0
Six weeks post birth.
Primary outcome [3] 300958 0
Effective neonatal suckling
The footage in the video of a moment of breastfeeding were observed. They are used to construct the indicator the following criteria: the amount of milk obtained by the method of double heavy. The time of suction effective, the number of suctions made and the construction of the saved
Timepoint [3] 300958 0
two weeks post birth
Secondary outcome [1] 331277 0
Dyadic mutuality whith Code Mutuallity Dyadic
Timepoint [1] 331277 0
six weeeks post birth
Secondary outcome [2] 331278 0
quality of life using SF-12
Timepoint [2] 331278 0
six weeks post birth
Secondary outcome [3] 332329 0
Neonatal growth Using anthropometric measurements: weight, height and cephalometric perimeter
Timepoint [3] 332329 0
six weeks post birth
Secondary outcome [4] 332330 0
Development Measured observing the evolution of the characteristics of the oral suction
Timepoint [4] 332330 0
six weeks post birth

Eligibility
Key inclusion criteria
New mothers
Newborns full term
Healthy dyads
Newborns without congenital diseases
Mothers who can read and write
Dyadic without contraindications to breastfeeding
Mothers with breastfeeding intentions at least the first month
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers with cognitive impairments or diagnosed mental illness
Mother or child hospitalization during follow-up time
Breastfeeding suspension

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer softwar
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Was calculated to establish differences between and within groups with repeated measurements. alpha: probability of incurring type I error Beta: probability of incurring type II error Delta: upper bound of the standard deviation from the valuesproduced by the total variable of the scale used deviation standard: Minimum difference between the means of the groups to establish the value of beta K: number of groups
Values established for the sample of the sample. alpha = 0.04 beta= 0.01 Delta = 0.8s K = 2 Taking into account these precisions of the required size is 60 dyads. The size of the global sample previously identified by 120 dyads, ie 60 dyads per group.


Inferential Statistics:
To test the hypotheses raised, a normality test will be performed first to determine the distribution of each of the variables. Once established, a path of analysis with parametric tests will be considered according to the normal distribution and for the non-normal distribution, a path of analysis with non-parametric tests. The significance of the tests is set at p: <0.05. The analyzes follow two different ways, one to compare two groups (the experimental and the control); And the other to compare the group with itself at two different time points, in the first 14 days and 4 to 6 weeks

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/07/2016
Date of last participant enrolment
Anticipated
Actual
30/10/2016
Date of last data collection
Anticipated
Actual
27/11/2016
Sample size
Target
120
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 8626 0
Colombia
State/province [1] 8626 0
Bogota D.C

Funding & Sponsors
Funding source category [1] 295491 0
University
Name [1] 295491 0
Universidad Nacional de Colombia
Country [1] 295491 0
Colombia
Funding source category [2] 296026 0
Government body
Name [2] 296026 0
Colciencias
Country [2] 296026 0
Colombia
Primary sponsor type
University
Name
Universidad Nacional de Colombia
Address
Carrera 30 #43-06 Edificio 228
Country
Colombia
Secondary sponsor category [1] 294914 0
Government body
Name [1] 294914 0
Colciencias
Address [1] 294914 0
Avenida Calle 26 # 57-41 Torre 8 - Pisos del 2 al 6
Country [1] 294914 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296819 0
Comite de Etica de la facultad de Enfermeria de la Universidad Nacional.
Ethics committee address [1] 296819 0
Ethics committee country [1] 296819 0
Colombia
Date submitted for ethics approval [1] 296819 0
10/02/2016
Approval date [1] 296819 0
18/04/2016
Ethics approval number [1] 296819 0
Acta N06 de 2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1433 1433 0 0
/AnzctrAttachments/372267-AVAL-016-2016 LUCY MARCELA VESGA.pdf (Ethics approval)
Attachments [2] 1436 1436 0 0
/AnzctrAttachments/372267-Aval san Jose.pdf (Ethics approval)

Contacts
Principal investigator
Name 72126 0
Mrs Lucy Marcela Vesga Gualdron
Address 72126 0
Universidad Nacional de Colombia Carrera 30 #45-06 Edificio 228 Bogota D.C. America del sur.
Country 72126 0
Colombia
Phone 72126 0
+54 3006071569
Fax 72126 0
Email 72126 0
lmvesgag@unal.edu.co
Contact person for public queries
Name 72127 0
Lucy Marcela Vesga Gualdron
Address 72127 0
Universidad Nacional de Colombia Carrera 30 #43-06 Edificio 228 Bogota D.C. America del sur.
Country 72127 0
Colombia
Phone 72127 0
3006071569
Fax 72127 0
Email 72127 0
lmvesgag@unal.edu.co
Contact person for scientific queries
Name 72128 0
Lucy Marcela Vesga Gualdron
Address 72128 0
Universidad Nacional de Colombia Carrera 30 #43-06 Edificio 228 Bogota D.C. America del sur.
Country 72128 0
Colombia
Phone 72128 0
3006071569
Fax 72128 0
Email 72128 0
lmvesgag@unal.edu.co

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of infant stimulation on the adaptation to birth: a randomized trial.2019https://dx.doi.org/10.1590/1518-8345.2896.3176
N.B. These documents automatically identified may not have been verified by the study sponsor.