| CTRI Number |
CTRI/2025/07/089918 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of an Audio Visual Tactile
Vestibular (ATVV) stimulation program administered by mothers on
improving sensory processing, breast feeding performance, mother infant bond
in mothers when compared to infants receiving usual care in Neonatal
Intensive Care Unit.
|
|
Scientific Title of Study
|
Effectiveness of parent-administered multisensory
stimulation using the “Auditory Tactile Visual Vestibular intervention
(ATVV)” on infant sensory processing, breastfeeding performance and postpartum bonding in mothers of hospitalized premature infants, when compared
to usual care- A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aruna R |
| Designation |
Student |
| Affiliation |
Christian Medical College |
| Address |
Room no 495, CARING Clinic, Department of Neonatology
Occupational Therapy Unit,
Vellore - 632004,
Christian Medical College,
Vellore
Vellore - 632004,
Vellore
TAMIL NADU
632004
India |
| Phone |
09442386174 |
| Fax |
|
| Email |
arunajona@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Joseph Thomas Raj Bedford |
| Designation |
Assistant Professor (OT) |
| Affiliation |
Christian Medical College |
| Address |
Child and Adolescent Psychiatry Unit,
Department of Psychiatry,
Christian Medical College
Vellore
TAMIL NADU
632002
India |
| Phone |
9894542067 |
| Fax |
|
| Email |
josephbedford@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Joseph Thomas Raj Bedford |
| Designation |
Assistant Professor (OT) |
| Affiliation |
Christian Medical College |
| Address |
Room,137
Child and Adolescent Psychiatry Unit,
Department of Psychiatry,
Christian Medical College
TAMIL NADU
632002
India |
| Phone |
9894542067 |
| Fax |
|
| Email |
josephbedford@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid Research Funding, Christian Medical College Vellore Tamil Nadu India 632002 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College
Vellore
Tamil Nadu India 632002 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrArunaR |
Christian Medical College |
Room no 495, CARING Clinic, Occupational therapy unit, CMC, Vellore and CARING clinic
Vellore
TAMIL NADU |
09442386174
aruna.r.ahs24@cmcvellore.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB), CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Auditory Tactile Visual Vestibular intervention
(ATVV) |
ATVV Intervention stands for Auditory, Tactile, Visual, and Vestibular Stimulation. It is a multisensory intervention commonly used in neonatal and infant care, especially for preterm or medically fragile infants, to promote development, bonding, and regulation.
The ATVV intervention involves providing infant directed talk using a soothing female voice (auditory stimulation) while the mother massages the infant for 10 minutes (tactile stimulation). This is
followed by 5 minutes of horizontal rocking (vestibular stimulation). Throughout
the 15-minute session, the mother also tries to establish eye contact with the infant (visual stimulation)
The mother will be asked to perform the intervention twice a day, 6 days a week for 3 weeks. |
| Comparator Agent |
Usual care |
The control group will receive usual care which
includes the following routine interventions: a. The lactation nurse is
consulted in case of difficulties in breastfeeding, b. Group based
education sessions are provided to mothers once a week on various
topics including breastfeeding, c. The Occupational Therapist
teaches an early stimulation program (based on sensory system development and multisensory stimulation principles) prior to
discharge to all premature infants which is advised to be continued at
home. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
from birth to 1-year corrected age follow up |
|
| ExclusionCriteria |
| Details |
Mothers with post-partum depression and
known case of psychiatric comorbidities, mothers who are unable to
breastfeed due to any medical condition, babies with major
congenital abnormalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sensory processing ability of infants using the Infant Sensory
Profile 2 (ISP-2) |
t1:3 weeks after intervention
t2:one year corrected age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Breastfeeding performance
Post-partum bonding in mothers
Neurodevelopmental outcomes using the Peabody Developmental Motor
Scales (PDMS-2) |
t1:3 weeks after intervention
t2:1-year corrected age
PDMS Scale administered at 1-year corrected age |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sensory experiences are crucial for brain development, particularly in preterm infants. In utero, fetuses experience rhythmic multisensory input, but premature infants in the NICU often face sensory overload or under stimulation. These challenges can lead to sensory processing issues and increase the risk of neurodevelopmental problems, such as ADHD, ASD, and learning difficulties. Disruptions in sensory processing may result in Sensory Processing Disorder (SPD), affecting motor coordination, sensory discrimination, and emotional responses. Research shows that structured multisensory stimulation, including auditory, tactile, visual, and vestibular input, can benefit preterm infants’ neurodevelopment. Audio Tactile Visual Vestibular (ATVV) is a type of structured multisensory stimulation for premature infants. ATVV intervention focuses on sensory systems that are well developed in preterm infants and has positive behavioral and physiological findings. ATVV has shown positive effects, including improved alertness, feeding, weight gain, shorter hospital stays, and better developmental outcomes. It also strengthens parent-infant bonding and reduces maternal stress. In most studies, the interventions were administered by trained professionals. Administration by the mother will help implement the concept of family-centered care, empowering and involving the mother in vital interventions. The study aims to evaluate the effectiveness of parent administered ATVV program, on sensory processing, breastfeeding performance, post-partum bonding, weight gain, and length of hospital stay. This randomized controlled trial aims to evaluate the effectiveness of parent administered multisensory stimulation using the Auditory Tactile Visual Vestibular intervention (ATVV) on premature infants’ sensory processing, breastfeeding performance, and post-partum bonding in mothers, compared to usual care. Conducted at CMC Vellore’s NICU and CARING clinic, the study will involve 82 participants divided into intervention and control groups. Mothers in the intervention group will perform the ATVV procedure for three weeks, with assessments conducted at discharge and one year follow-up. The results will provide valuable insights into the effectiveness of parent administered sensory interventions on infant outcomes and parent bonding, helping to further develop intervention protocols. |