| CTRI Number |
CTRI/2017/08/009541 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of massage on weight and neuro muscular maturity |
|
Scientific Title of Study
|
Effect of tactile-kinesthetic stimulation on weight gain and neuro muscular maturity in preterm neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajalakshmi R |
| Designation |
M.Sc. Nursing student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room Number 102
College of Nursing
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvanthri Nagar
Gorimedu
Puducherry
Nil
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7667106740 |
| Fax |
- |
| Email |
rajivino31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nivedita Mondal |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Neonatology
2nd Floor, Room number.6210
Women and Children Hospital
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvanthri Nagar
Gorimedu
Puducherry
nil
Pondicherry
PONDICHERRY
605006
India |
| Phone |
- |
| Fax |
- |
| Email |
nive.m8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Vetriselvi |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room Number 109, 1st floor
College of Nursing
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvanthri Nagar
Gorimedu
Puducherry
nil
Pondicherry
PONDICHERRY
605006
India |
| Phone |
- |
| Fax |
- |
| Email |
vetreselve1967@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER
Dhanvanthri nagar
Gorimedu
Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivedita Mondal |
Neonatal Intensive Care Unit |
1st Floor, Room number. 6140
Women and children Hospital
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvanthri Nagar
Gorimedu
Puducherry
Pondicherry
PONDICHERRY |
8098912969
-
nive.m8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm neonates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Tactile kinesthetic stimulation |
ï‚´ Tactile-kinesthetic stimulation will be done for 10 consecutive days. The sessions comprises of three segments which were two five-minute phases of tactile stimulation and one five-minute phase of kinesthetic stimulation given during the middle phase.
The tactile-kinesthetic stimulation will be given over a 15 minutes session in the following sequence:
ï‚´ first: 5 minutes tactile stimulation,
ï‚´ second: 5 minutes kinesthetic stimulation and
ï‚´ third: 5 minutes tactile stimulation.
Tactile stimulation
 This study used the massage therapy protocol according to IAP National President’s Action Plan 2004 Neuro-developmental Follow-up Module on Early stimulation [page no. 73].
ï‚´ During tactile stimulation, the neonates will receive gentle firm strokes of atleast 12 strokes to each area after application of coconut oil before massaging (to reduce friction) with the fingers of both hands of therapist for 5 one-minute periods over each region in the following sequence:
 Tiny circles on the face then smooth the baby’s forehead with both hands at the center; gently press outside as if stroking the pages of the book. Make small circles around the baby’s jaw, massaging around the baby’s mouth.
 Gently stroke the baby’s chest as if stroking the pages of a book.
ï‚´ Stroke each arm alternately from central outwards, open the palms and massage each finger separately.
 Massage the abdomen from baby’s right side to the left in a clockwise direction.
ï‚´ Stroke and massage each leg and foot separately.
 Massage the abdomen from baby’s right side to the left in a clockwise direction.
ï‚´ Stroke and massage each leg and foot separately.
 Stroke the baby’s back – first back and forth across, then in long, sweeping lines from shoulders to feet. Always keep one hand on the baby.
ï‚´ Stroke the buttocks in circular motion.
Kinesthetic stimulation
ï‚´ For the kinesthetic phase, neonate will be placed in supine position. This phase consists of six passive flexion/extension movements, each lasting approximately 10 seconds, in the following sequence:
ï‚´ right arm
ï‚´ left arm
ï‚´ right leg
ï‚´ left leg
ï‚´ both arms and legs simultaneously.
Finally tactile stimulation will be repeated in the third phase for 5 minutes in the same sequence as mentioned earlier.
|
|
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Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
Neonates who are born between 32 and <37 weeks of gestation
Neonates with stable vital signs
Neonates who are not on oxygen therapy
|
|
| ExclusionCriteria |
| Details |
Neonates who have undergone surgery
Neonates with any congenital anomalies
Neonates who are critically ill |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to find out if tactile-kinesthetic stimulation leads to better weight gain and neuromuscular maturity in the preterm neonates |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
28/11/2016 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Study Title Effect of tactile-kinesthetic stimulation on weight gain and neuromuscular maturity in preterm neonates.
Research hypothesis The Tactile-kinesthetic stimulation is effective in weight gain & neuromuscular maturity among preterm neonates.
objective of the study To assess the effectiveness of tactile-kinesthetic stimulation on weight gain & neuromuscular maturity in preterm neonates
Names of the groups to be studied - 2 groups Group I: Control group – Preterm neonates with conventional/routine care. Group II: Experimental group – Preterm neonates with Tactile-Kinesthetic Stimulation
Procedure: ´ Tactile-kinesthetic stimulation will be done for 10 consecutive days. ü In the experimental group, tactile-kinesthetic stimulation will be given for 15 minutes, 2 times a day for 10 days. Control group will not receive any intervention. ü The intervention will be done about 1 hour after feeds with the neonate nursed under a radiant warmer, fully undressed except for the diapers. A temperature probe and SpO2 monitor will be attached. The heart rate and SPO2 will be monitored before and after the procedure. If the neonate starts crying or passes stools/urine during the session, the procedure will be stopped temporarily till the diapers are changed and the neonate becomes calm again. In the control group the neonates will be exposed to similar conditions to which the test babies were exposed - they will be nursed naked 1 hour after feeds and subjected to routine handling like changing diapers, etc and their heart rate and oxygen saturation will be recorded. ü The mother’s of cases and controls will be told not to provide any kind of massage to the neonates, except for KMC. ü Weight and neuromuscular maturity will be assessed before and after intervention period. ü Blinding will be done in the post-intervention assessment period in order to avoid bias. ü After intervention period the neonate’s neuromuscular maturity & weight outcome will be assessed twice by a person other than the investigator who was not informed of the intervention group allocation ie., ´ At the 10th day of intervention ´ At the corrected age of 40 weeks. The baseline scores and scores after intervention at 10th day and 40th corrected week will be compared. |