|Year : 2018 | Volume
| Issue : 1 | Page : 12-19
Yakson touch and kinesthetic stimulation on development of high-risk neonates in neonatal intensive care units: A randomized controlled trial
Preeti Parashar, Asir John Samuel
Departments of Neonatal and Pediatric Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Haryana, India
|Date of Web Publication||6-Feb-2018|
Dr. Asir John Samuel
Department of Neonatal and Pediatric Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana - 133 207, Haryana
Source of Support: None, Conflict of Interest: None
Background and Objectives: About 15 million babies are born preterm every year. Among them, almost 1 million neonates die due to complications. Even the survivors are prone to lifetime disability. Yakson touch and kinesthetic stimulation techniques have been proved to be effective in minimizing the complications and disability, but there is no standardized protocol. Hence, we aimed to investigate the efficacy of Yakson touch in combination with kinesthetic stimulation (YAKIN) on the development of high-risk neonates. Materials and Methods: Twenty-eight neonates were recruited through parental consent from a recognized tertiary care teaching hospital for this two-group pre- and post-test design of randomized controlled trial and were allocated into control group (n = 14) and experimental group (n = 14) by block randomization method. Neonatal behavioral assessment scale (NBAS) was performed on all recruited neonates. The duration of intervention was 5 days out of 7 days. The experimental group received Yakson touch and kinesthetic stimulation and the control group received conventional handling which included developmental positioning and Kangaroo mother care. On the 7th day, NBAS was done again to document the effect of the intervention. Results: Neonates median gestational age of 35 (34, 35.3) weeks in experimental and 35 (33.5, 36) in control group were recruited. There were no significant differences between the groups (p> 0.05). Large effect size index was seen in the experimental group. Conclusions: Efficacy of the standardized protocol YAKIN has been verified, and it may have positive effects on the overall development of high-risk neonates.
Keywords: Behavior, low birth weight, motor, preterm, tactile, Yakson
|How to cite this article:|
Parashar P, Samuel AJ. Yakson touch and kinesthetic stimulation on development of high-risk neonates in neonatal intensive care units: A randomized controlled trial. J Clin Neonatol 2018;7:12-9
|How to cite this URL:|
Parashar P, Samuel AJ. Yakson touch and kinesthetic stimulation on development of high-risk neonates in neonatal intensive care units: A randomized controlled trial. J Clin Neonatol [serial online] 2018 [cited 2018 Aug 15];7:12-9. Available from: http://www.jcnonweb.com/text.asp?2018/7/1/12/224811
| Introduction|| |
A neonate is a baby under 28 days or 4 weeks of age while a neonate born in <37 weeks of gestation is preterm neonate  and is considered a high-risk neonate as they are prone to delayed growth and development, mental and physical disability, lifetime disability such as learning disability, visual or hearing impairments, or even increased risk of death.,, The preterm newborn moves to smaller degrees as compared to full-term newborns. In high-risk neonates, there are increased chances of appearance of development impairments at later stage of development.,, Stimulation given at an early stage to neonates can alter the growth of the brain cells, improve adaptive behavior, and thus, age-appropriate development is likely to be achieved.
Yakson is a Korean therapeutic touch given to neonates and infants by caressing their abdomen with one hand while the other hand is placed on the back of the neonate to relieve their pain and to calm them down. It was traditionally used by Koreans by caressing the aching body part of their children with a belief that it would relieve their pain. Yakson is one among the most effective and safe methods of tactile stimulation for preterm neonates., Tactile and kinesthetic stimulation techniques have proven to be effective on preterm neonates development, but there is no standardized protocol for these interventions. Therefore, there is need to describe the methodology as well as the effects accurately. The role of physiotherapy interventions in the treatment of high-risk neonates has not been established.,, The high-risk neonates are prone to developmental delays, and early intervention is most effective for them owing to the plasticity of the brain in early infancy.,
Pepinoa and Mezzacappa concluded that tactile-kinesthetic stimulation is a promising tool, but there is no standard protocol for its application. Aliabadi and Askary examined the effects of tactile-kinesthetic stimulation on the physical and behavioral development of infants with low birth weight (>1500 g and <2499 g). They found that tactile-kinesthetic stimulation did not have any adverse effects on the physiological parameters and helped in the improvement of adaptive behavior of the low birth weight infants. Kachoosangy and Aliabadi stated that tactile-kinesthetic stimulation is effective in improving the motor behavior and they suggested that there is a need for studies in other aspects of behavior in low birth weight infants.
Ferreira and Bergamasco concluded that tactile and kinesthetic stimulation had a positive effect on adjustment and self-regulation behavior of preterm neonates. They implied the need for studies that focus on the effects of these interventions. Eshghi et al. concluded that Yakson therapeutic touch increased the sleep scores and thus significantly affected the behavioral response of premature infants. Bahman Bijari et al. concluded that Yakson and gentle human touch increased sleep states of the infants and decreased stress and energy consumption in infants in Neonatal Intensive Care Unit. Since there is a lack of significant evidence for use of Yakson and kinesthetic stimulation to improve the development of high-risk neonates, the present study is aimed at determining the effects of tactile stimulation in the form of Yakson touch and kinesthetic stimulation in the form of passive movements on low birth weight neonates (<2500 gm) and preterm neonates (<37 weeks) through a randomized controlled trial (RCT).
| Materials and Methods|| |
The study design was a single-blinded RCT of two-group pre- and post-test design. As this study involved human subjects, ethical clearance has been obtained from research and student project committee of Maharishi Markandeshwar Institute Physiotherapy and Rehabilitation, Mullana, Haryana and Institutional Ethical Committee (IEC) of Maharishi Markandeshwar University (IEC/MMU/2016/751). The ethical clearance was obtained from institutional research ethics committee in accordance with the guidelines laid by ICMR (2006) and Helsinki Declaration (Revised 2013). The trial was registered under ClinicalTrials.gov, NCT02815904. Parents of infants born prematurely and with low birth weight were randomly approached for consent before their child being randomly allocated into one of two groups – an intervention group or the “usual care” control group. Parents of all the individuals received a written explanation of the trial before the individuals enter into the study and they were given informed forms to be signed before their child being involved in the trial. Individuals were recruited from a single center, a recognized tertiary care teaching hospital.The study was conducted within the neonatal Intensive Care Unit (NICU), Department of Paediatrics of a recognized tertiary care teaching hospital. The simple random sampling method was used to recruit the samples using random number generator (RNG), an application provided by the Statistical Package for Social Sciences (SPSS version 16.SPSS Inc., Chicago, IL, USA).
Participant's recruitment, interventions, and outcomes
Neonates of either gender with birth weight <2500 g and born before 37 weeks of gestation was recruited into the study in the 1st week of their life. Medically unstable neonates requiring lifesaving interventions such as assisted ventilation and cardiac support medicines, or neonates with communicable disease or congenital anomaly or skin infection were excluded from the study. The study was undertaken for a total duration of 1 year between June 2016 and May 2017. Each neonate will receive their allocated interventions once a day for 1 week (5 days a week) for 25 min a day after the random allocation.
Outcomes of the study were measured by the qualified primary researcher in terms of the neonatal behavioral assessment scale (NBAS) at baseline and end of 1 week intervention. The primary researcher had taken sufficient training in NBAS on neonates before enrollment in the study. Yakson touch and kinesthetic stimulation constituted the independent variables while the dependent variable was the development of neonates as per the scores of NBAS.
Sample size estimation
Sample size was estimated on the basis of the pilot study. The formula for sample size was comparison of means of two-sample parallel design study,n = 2 [(Zα + Zβ) s/d]2 (where Zα = level of significance, Zβ = power of study, s = pooled standard deviation (SD) of the two samples, d = minimal clinically important difference for NBAS total score based on our pilot study. Zα was set as 1.98, as α was assumed to be 0.05 to greatly minimize type 1 error. Zβ was 0.84 and thereby maintaining the power of the study at 80%. From our unpublished pilot study, we have obtained s = 18.9 and d = 20.9. Thus, we have obtained the sample size of 14 in each group considering 10% dropout rate.
Assignment of intervention
Neonates meeting the inclusion criteria for the study were identified and following parental consent were randomly allocated to one of two groups: A – the experimental group (n = 14), or B – the control group (n = 14) [Figure 1]. By the block randomization method, the neonates were randomly allocated using sequentially numbered, opaque sealed, envelopes. The parents of the neonates were instructed not to reveal their allocated groups of their baby until the study commenced. An independent associate investigator person who was not involved in the study intervention delivery generated the allocation sequence, enrolled the participants, and assigned participants to their allocated group. As the primary researcher is a postgraduate student and the study was undertaken as a part of her curriculum, blinding during recruitment, intervention and data collection phases was not possible. Data analysis was performed by a blinded independent researcher.
Experimental group intervention
- Universal precautions to maintain sterile conditions were taken
- Then the therapist warmed both hands with a radiant warmer so that the temperature of the palms reached between 93F and 94F (33.9°C–34.4 8°C). A digital thermometer was used to check the temperature of the palms. By energy loss or decay mechanism, it is not uncommon to observe decay or loss of heat from palm. Heat loss is inevitable during the application of Yakson touch through the palms. But as the radiant warmer was in on state when executing the intervention, the energy loss was minimal
- The therapist relaxed the arm and shoulder muscles for 1 min and performed breathing to accumulate Ki energy (an internal life-energy or the vitality or a spiritual energy, assumed to be in the range near-infrared radiation, an electrostatic field, sound waves or a magnetic field, between the wavelength range of 0.8 and 2.7 μm), on the palms
- The therapist applied Yakson to the neonate with the neonate being in supine position. Yakson was given for 15 min, divided into resting the hands, caressing gently, and further resting the hands, each lasted for 5 min. Throughout the application of Yakson, fingers and palm of the therapist was in constant contact with literally no pressure on the infant
- Resting the hands for 5 min-while one hand was resting on the chest and abdomen of the neonate, with the other hand supporting the back, the therapist concentrated on the resting hands passing Ki energy passing to the neonate. During this, the therapist breathed slowly and remained relaxed
- Caressing gently for 5 min-with the hands in the same position, the therapist caressed the neonate repeatedly for 5 min. The therapist applied caressing strokes for 1 min, rested for 30 s, caressed for 1 min, rested for 30 s, and then caressed for a further 2 min. The therapist caressed the abdomen and chest of the infant a clockwise circular direction, with a diameter of 1 cm, every 10 s
- The therapist then rested the hands as previously described for 5 min.
Immediately following the Yakson, for giving kinesthetic stimulation the neonate was placed in supine position. There were six passive flexion and extension movements. Each of the movement lasted for approximately 10 s. The movements were performed in the following order-right arm, left arm, right leg, left leg, and both legs simultaneously involving the full range of motion in major joints such as shoulder and hip joints. Thus, each movement completed in approximately 1.7 s (6 passive flexion and extension movements in 10 s).
Control group treatment
The neonates in control group received Kangaroo mother care (holding the neonate skin to skin by mother) for 1 h a day and developmental positioning (positioning of preterm infants for optimal physiological development) for 20 min/h for 5 days.
The NBAS was used to monitor the effects of Yakson touch and kinesthetic stimulation on the development of high-risk neonates. Baseline reading of NBAS was recorded for all enrolled neonates before the beginning of intervention. The NBAS is an instrument designed to assess full-term babies from 37 to 48 weeks' gestation with excellent test-retest reliability; it has been used in over 700 studies worldwide, as a systematic way of observing the individual baby's responses to moderately aversive (e.g., reflexes and motor tone) and nonaversive (e.g., tracking, turning to sound) stimulation. The NBAS contains 28 behavioral items, 18 reflex items, and 7 supplementary items for fragile or high-risk infants. It is a neurobehavioral screening tool, and will identify gross abnormalities or asymmetries. All items are administered when the baby is in the appropriate behavioral state (States 1–6, from deep sleep to crying), and there is a sequence to follow. The motor system in NBAS includes the general tone, motor maturity, pull-to-sit, defensive, and activity level. There are six main clusters ⁄ packages scored 1–9 (28 items), seven supplementary items scored 1–9, and 18 reflex ⁄ motor items scored 0–3. The scoresheet included 27 behavioral items, each of which was scored on a nine-point scale and twenty elicited responses, each of which is scored on a three-point scale. Time taken in administration is 20–30 min. It is a naturalistic observation, elicited items, and handling required administered according to infant's state.
The sleep states are – (i) Deep sleep with regular breathing, eyes closed, (ii) Light sleep with eyes closed; rapid eye movements can be observed under closed lids; low activity level. Awake States are (iii) Drowsy or semi-dozing; eyes may be open or closed, eyelids fluttering; activity level variable. (iv) Alert, with bright look, Minimal motor activity (v) Eyes open; considerable motor activity, (vi) Crying. The domains are habituation, social interactive, motor system, state organization, state regulation, autonomic system, supplementary system, and reflexes.
To minimize dropouts and to facilitate participant retention, parent of the neonates was assured 30% fee concession toward pediatric physiotherapy consultation. They were reminded of the physiotherapy visits over Short Messaging Services and if their visits were delayed by 2 days, then telephonic follow-up was done.
Data monitoring committee
Data collected was maintained by the data and safety monitoring committee (DSMC), which was headed by the chairman of the student project committee. It was independent from the primary researcher and had its role in monitoring the outcome of the intervention and to alarm the researcher if any adverse reaction such as more than 20% declining tendency of NBAS baseline score occurs. Interim analysis was performed, when 50% of neonates had been randomized, to check whether the effect of intervention is proceeding as expected or not and to document other unintended effects of trial interventions. There were no adverse events that required stopping the intervention. DSMC audited the trial conduct once in 15 days by an independent statistician the date and time of which was not disclosed to the primary researcher.
The data were collected, entered, and analyzed by the primary researcher. Either the Wilcoxon signed rank test or a paired t-test was used to compare the pre- and post-intervention score of the NBAS, depending on whether the data are normally distributed or not. Similarly with a Mann–Whitney U test or an independent t-test was used to compare the NBAS scores of experimental group and control group. Data were analyzed using the statistical software (SPSS version 16. SPSS Inc. Chicago, IL, USA). The level of significance was set as 0.05. Missing data due to unavoidable causes was managed by intention-to-treat analysis.
| Results|| |
A total of 28 individuals were recruited in this RCT. There were five cases of missed to follow-up out of which two each from both groups got discharged early and one of the individuals in control group died due to cardiac arrest. Missing data were analyzed using intention to treat analysis. Detailed demographic data are displayed in [Table 1]. Central tendency and dispersion of the data were expressed in median and interquartile range. Pre- (baseline) and post-intervention changes in NBAS subcomponent scores of the control and experimental group (Mann–Whitney U test) were given in [Table 2]. Within the group pre- and post-differences of control and experimental group (Wilcoxon signed rank test) were displayed in [Table 3] and [Table 4], respectively. Very large effect size was noted in the experimental group (Cohen's d >1.3).
|Table 2: Comparison of Neonatal Behavioral Assessment Scale score between experimental and control group|
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|Table 4: Comparison of postintervention values between experimental and control group|
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| Discussion|| |
A preterm neonate in NICU is deprived of what a term neonate gets, that is touch of his mother and is exposed to various noxious and aversive stimuli like heel prick handling by the NICU staff whose touch is unknown to them. Therefore, Yakson touch might have positive effect on social development, improved sleep status and have soothing and calming behavior on neonates.,, Furthermore, kinesthetic stimulation should be included in early intervention program to promote adaptive motor behavior of neonates with LBW.,
Pederson et al. examined the motor function of low birth weight preterm infants to predict developmental delays which may appear later and found that low birthweight infants exhibit different pattern of motor development in their first year of life as compared to full-term infants. Mahoney and Cohen in their review article concluded that there are evidence that early intervention assists the infants in age-appropriate development. Anderson stated that selected sensory input can facilitate physiological stability and growth if administered at an early age. Therefore, early intervention is advocated to prevent the occurrence of neurodevelopmental disorders later in life.
Individual studies have shown that Yakson touch can provide pain relief, improve sleep, affects their behavioral response, decreases the stress levels, increases maternal attachment, and has calming effects., No adverse effects have been noted with Yakson. Tactile-kinesthetic stimulation have been proved to have positive effects on the behavior of neonates, such as motor development, self-regulated behavior (regular breathing, state of alertness, balanced tone, a range of postures, coordinated movements, hand-to-face movement control, suction, grip, support, etc.), increased daily weight gain, adaptive behavior, and reduced hospital stay.,
The NBAS was chosen for assessment because it is reliable tool with the intrarater reliability between 0.85 and 1.00. In addition, incorporates all components of behavior and motor development of the neonate. It is a tool for neurological and behavioral assessment capable of detecting any gross abnormality or asymmetry.
There were no significant differences, (P > 0.05) between both groups in any of the subcomponents of NBAS. But when compared before and after intervention in the experimental group, there significant differences in hand to mouth facility and lability of skin color (P < 0.05). This study is in line with previous studies as there was no significant improvement in the subcomponents of NBAS after tactile and kinesthetic stimulation except in motor system.,
A first of its kind, effect size estimation was done. The effect size index calculation revealed very large effect size in experimental group, (Cohen's d >1.3). Recent literature stated that Yakson is given by mother, grandmother, or any other family member who touch is recognized by the neonate. In the present study, Yakson was given by the therapist which might be a reason for not getting statistically significant results in both of the groups.
The two major limitations of the study were short duration (5 days) of the intervention and small sample size. Small sample size might affect the generalizability of the results. However, we have demonstrated the present sample size is sufficient to make the study of 80% power (1-β) and thereby minimizing the type-II error (β) <20%. Previous studies have shown that 10 days of tactile-kinesthetic stimulation resulted in improvement in behavioral and motor responses., Nevertheless, this was the first study to demonstrate the efficacy of Yakson touch in combination with kinesthetic stimulation (YAKIN) on the development of high-risk neonates. Therefore, we suggest further studies with longer duration of intervention. Also, studies can be performed where Yakson is given by mother or any other family member. A follow-up of the subjects after 1 year may reveal the effectiveness of early intervention in high-risk neonates.
| Conclusions|| |
Efficacy of the standardized protocol YAKIN has been verified. YAKIN may have a positive effect on various aspects of the development of high risk of neonates and is safe for administration in high-risk neonates as there was no adverse event noted in the study.
The authors are very thanks full to Dr. Arpna Bansal, MD (Pediatrics), Assistant Professor, Maharishi Markandeshwar Institute of Medical Sciences and Research and Dr. Vencita Priyanka Aranha, MPT (Pediatrics), Assistant Professor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, India for their valuable inputs towards the completion of this study. This study is supported by Maharishi Markandeshwar University PG Thesis Grant (MMU/1816706/2016).
Financial support and sponsorship
Maharishi Markandeshwar University PG Thesis Grant (MMU/1816706/2016).
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]