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An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.
Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians.
Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities.
In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse.
Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert.
At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Tactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days. |
|
| Control Group | Placebo Comparator | Control group was not given TKS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tactile-kinesthetic Stimulation | Procedure |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Birth Body Weight at 11 Days Old | Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated. | On the first day and 11 days old. |
| Change from Birth Body Weight at 40 Weeks of Postmenstrual Age | Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated. | On the first day and 40 weeks of postmenstrual age. |
| Change from Birth Body Weight at 3 Months Old | Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated. | On the first day and 3 months old. |
| Change from Birth Body Length at 11 Days Old | Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart. | On the first day and 11 days old. |
| Change from Birth Body Length at 40 Weeks of Postmenstrual Age | Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart. | On the first day and 40 weeks of postmenstrual age. |
| Change from Birth Body Length at 3 Months Old | Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hartono Gunardi, MD, PhD | Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Cipto Mangunkusumo Hospital | Jakarta Pusat | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23795251 | Background | Aliabadi F, Askary RK. Effects of tactile-kinesthetic stimulation on low birth weight neonates. Iran J Pediatr. 2013 Jun;23(3):289-94. | |
| 28235686 | Background | Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14. |
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| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| D047928 | Premature Birth |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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|
| On the first day and 3 months old. |
| Change from Birth Head Circumference at 11 Days Old | Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded. | On the first day and 11 days old. |
| Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age | Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded. | On the first day and 40 weeks of postmenstrual age. |
| Change from Birth Head Circumference at 3 Months Old | Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded. | On the first day and 3 months old. |
| Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age | Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72. | 6-24 hours of age and 11-14 days of age. |
| Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age | Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72. | 6-24 hours of age and term or 40 weeks of postmenstrual age. |
| Change from 6-24 hours of age Neurobehavior at 3 Months Old | Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72. | 6-24 hours of age and 3 Months Old. |
| Infant Development | Using Capute scales. | 3 months of age. |
| 24625129 | Background | Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15. |
| 24480603 | Background | Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27. |
| 24294064 | Background | Dosman CF, Andrews D, Goulden KJ. Evidence-based milestone ages as a framework for developmental surveillance. Paediatr Child Health. 2012 Dec;17(10):561-8. doi: 10.1093/pch/17.10.561. |
| 15856443 | Background | Dubowitz L, Ricciw D, Mercuri E. The Dubowitz neurological examination of the full-term newborn. Ment Retard Dev Disabil Res Rev. 2005;11(1):52-60. doi: 10.1002/mrdd.20048. |
| 32666281 | Background | Elmoneim MA, Mohamed HA, Awad A, El-Hawary A, Salem N, El Helaly R, Nasef N, Abdel-Hady H. Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. Eur J Pediatr. 2021 Jan;180(1):207-215. doi: 10.1007/s00431-020-03738-w. Epub 2020 Jul 14. |
| 24639794 | Background | Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8. |
| 21048258 | Background | Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6. |
| 11677298 | Background | Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactile-kinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001 Oct;38(10):1091-8. |
| 19030294 | Background | Moddemann D, Shea S. The developmental paediatrician and neonatal follow-up. Paediatr Child Health. 2006 May;11(5):295. |
| 19732117 | Background | Orton J, Spittle A, Doyle L, Anderson P, Boyd R. Do early intervention programmes improve cognitive and motor outcomes for preterm infants after discharge? A systematic review. Dev Med Child Neurol. 2009 Nov;51(11):851-9. doi: 10.1111/j.1469-8749.2009.03414.x. Epub 2009 Sep 1. |
| 16208048 | Background | Sankaranarayanan K, Mondkar JA, Chauhan MM, Mascarenhas BM, Mainkar AR, Salvi RY. Oil massage in neonates: an open randomized controlled study of coconut versus mineral oil. Indian Pediatr. 2005 Sep;42(9):877-84. |
| 19917121 | Background | Santos IS, Matijasevich A, Domingues MR, Barros AJ, Victora CG, Barros FC. Late preterm birth is a risk factor for growth faltering in early childhood: a cohort study. BMC Pediatr. 2009 Nov 16;9:71. doi: 10.1186/1471-2431-9-71. |
| 11045835 | Background | Soriano CR, Martinez FE, Jorge SM. Cutaneous application of vegetable oil as a coadjutant in the nutritional management of preterm infants. J Pediatr Gastroenterol Nutr. 2000 Oct;31(4):387-90. doi: 10.1097/00005176-200010000-00011. |
| 15106151 | Background | Vickers A, Ohlsson A, Lacy JB, Horsley A. Massage for promoting growth and development of preterm and/or low birth-weight infants. Cochrane Database Syst Rev. 2004;2004(2):CD000390. doi: 10.1002/14651858.CD000390.pub2. |
| 21321024 | Background | Woythaler MA, McCormick MC, Smith VC. Late preterm infants have worse 24-month neurodevelopmental outcomes than term infants. Pediatrics. 2011 Mar;127(3):e622-9. doi: 10.1542/peds.2009-3598. Epub 2011 Feb 14. |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |