Study design
A quasi-experimental design was carried out to assess effects of tactile-kinesthetic stimulation on feeding parameters and physical growth of preterm neonates. The study involved two groups; control and tactile-kinesthetic stimulation (intervention) groups.
Study setting
The study was conducted at a level II Special Care Nursery (American Academy of Pediatrics, 2012) (14) of Moi Teaching & Referral Hospital (MTRH), an academic hospital in the Western region of Kenya. It has 70-bed capacity, 11 incubators, and 54 cots. It provides care to preterm and moderately ill neonates who do not require mechanical ventilation.
Study population
The study population comprised preterm neonates admitted at SCN of MTRH. The SCN has an average of 90 neonates of whom majority (75%) are preterm (hospital records, 2017).
Sample size
Using Epi-Info software and main output variable as mean weight gain which was compared in the two groups, sample size was estimated to be 36 participants in each group, totaling to 72 participants for the study to detect average weight gain of 27±3 grams per day among the interventional group compared to average weight gain of 25±3 grams per day among the control group (12). Thus, change of average weight gain by two grams was detected. The estimated sample size was made at assumption of 95% confidence level and 80% power of study.
Eligibility criteria; neonates who fulfilled the following criteria comprised the study participants; a) on breast milk or formula feeds, b) born 28 to 37 weeks gestational age, c) ≥1000grams. The gestation was limited to ≥ 28 weeks and ≥1000grams based on significant neonatal mortality rate in neonates born before 28 weeks gestation and/or weighing <1000grams in MTRH (15). Neonates were excluded from the study if they; a) were critically ill and those on continuous positive airway pressure (CPAP) or b) had neonatal infections including severe sepsis or necrotizing enterocolitis.
Sampling method
Consecutive sampling was used to recruit preterm neonates for the study on day 3 of the neonate’s life. Study participants that met the eligibility criteria were consecutively selected in order of appearance according to their convenient accessibility. The first study participant was recruited in the control group while the subsequent with similar characteristics in the intervention group, this was continued until the desired sample size was reached.
Study tool
A study tool developed by the authors after thorough review of related literature on effects of TKS (1, 16) was used to collect data on a) neonates characteristics including gender, gestational age, and clinical risk index for babies (CRIB II) score; b) amount of feeds, signs of feeding intolerance (gastric residual >50% of previous feed as per MTRH hospital practices, abdominal distension and vomiting), and weight in grams. Data on feeding characteristics were analyzed on day 3, 10, 17, and 23 while that for weight on alternate days starting from day 3 up to day 23.
Study tool validity & reliability
Tools were reviewed for content validity by 5 experts in the field of pediatric nursing and suggestions made were incorporated into the tools. Medical records were used to gather information on amount of feeds and signs of feeding intolerance. Inter-rater reliability using two observers (research assistant and staff nurse at SCN) were done for weight recording. Notably, there was no variation in weight recording between the two observers. A pilot study was carried out on 12 preterm neonates (four in each group) at MTRH hospital prior to data collection to test the feasibility of the study. Neonates included in the pilot study were excluded from the main study. There were no amendments made to the study tool.
Study procedures
A researcher was trained on TKS by a specialized pediatric nurse to ensure moderate pressure is applied on the body surface in a manner to cause effect and not harm the neonate. The training was conducted in three sessions each lasting two hours. The first and second session were conducted in the skills laboratory while the third session at MTRH hospital. The first session comprised review of massage procedure and watching the video. The second session was return demonstration on a dummy. The third session was practice on preterm neonates to achieve competency. Two research assistants (RA’s - Bachelor of Science in nursing intern) were trained on data entry. The RA’s were blinded to aim of study, group assignment, and interventions received by the preterm neonates. In addition RA’s had no access to study data; completed assessment tools, and notes.
Control group
Neonates in this group didn’t receive any specific stimulation rather had standard care of the SCN.
Tactile-Kinesthetic Stimulation (TKS) group
The group received TKS in addition to standard care of SCN.
Tactile-kinesthetic stimulation involved three sessions per day; morning, afternoon, and evening for 10 days starting day 3 of life (initial contact). After thorough hand scrubbing, the researcher placed her warmed hands on the preterm neonate’s body. Access ports were used for neonates in the incubator to prevent hypothermia. The preterm neonates were on a cardiorespiratory monitor for physiological monitoring with set alarm to detect deviation from normal that would warrant discontinuation of the TKS. The stimulation was given 1-2 hours after feeding. A small amount of sunflower oil was used for TKS to decrease injurious friction between surfaces (providers’ palms and neonate’s skin) and was removed with cotton after the stimulation. Stimulation was temporarily stopped if the neonate started crying or passed urine or stool. The stimulation was continued when the neonate regained stability. The 15-minutes stimulation included three standardized 5 minutes phases.
The phases were as follows:
Phase 1: Preterm neonates were placed in prone position. Moderate pressure (sufficient to produce slight skin indentation or slight skin color change from pink to white) was used to provide 12 strokes with palms of the hands, each stroke lasting 5 seconds. The strokes were provided in each area as follows: (a) head - from forehead hairline over scalp down to neck with alternate hands; (b) neck - from midline outwards with both hands simultaneously; (c) shoulders - from midline outwards with both hands simultaneously, and (d) back - from nape of neck down to buttocks, long stroke with alternate hands.
Phase 2: The preterm neonates were placed in supine position. Twelve moderate pressure strokes with palms of the hands, 5 seconds each, were provided in each area as follows: (a) forehead - from midline, outwards with both hands simultaneously; (b) cheeks - from side of nose, with both hands simultaneously in rotating and clockwise direction; (c) chest - ‘butterfly’ stroking from midline upwards, outwards, downwards and inwards back to initiating point; (d) abdomen - from the appendix, in a clock wise direction around abdomen avoiding the epigastrium and probes, with gentle strokes; (e) upper limbs (each separately) - from shoulders to wrist using alternate hands for stroking; (f) lower limbs (each separately) - from hips to ankles using alternate hands for stroking; (g) palms - from wrist to finger tips using alternate hands for stroking; and (h) soles - from heel to toe tips using alternate hands for stroking.
Phase 3: Kinesthetic stimulation was done for 5 minutes. The intervention comprised five passive flexion and extension movements of each large joint (shoulder, elbow, wrist, hip, knee, and ankle) for two seconds.
The massage therapy protocol was adopted from Mathai 2001 (17) a modification of Field et al. (1986) protocol for medically stable preterm neonates.
Data management and analysis
Data from study tools was coded and entered into Statistical Package for the Social Sciences (SPSS) version 20 database that was created for the study. Study tools were visually checked for completeness and accuracy before data entry. Descriptive statistics were computed for the baseline clinical data of the study participants. Chi-square test and student t-test were used to show relationship between variables (gender, GA, Apgar score, birth weight, and CRIB II score) between TKS and control groups. Means and (% confidence intervals, standard deviations (SDs) and interquartile ranges (IQR) were computed to describe dependent variables; amount of feed, signs of feeding intolerance, duration to attaining full breastfeeding and weight. Mann Whitney U test, Student t-test, Chi-square test, and Fisher’s exact test were used to determine whether there was any difference between TKS and control groups in amount of feeds and signs of feeding intolerance. Student t-test and Mann Whitney U test were used to determine whether a difference existed in weight of moderate and late preterm neonates between the two groups.