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In 1983, the National Institute of Child Health and Human Development, Bethesda, Maryland, funded a three year controlled study in Columbus, Ohio to investigate the effectiveness of motion simulation (vibration) and sound on colicky infants. After a six month pilot study the project and the clinical trials provided favorable results which were presented to a nationwide panel of scientists at the N.I.H. This peer group review approved the establishment of a major research project to investigate this effectiveness on 100 colicky subjects. The research utilized the frequencies and amplitudes of vibration and the synergistic effects of sound, which when applied to a crib, are similar to those experienced by a baby riding in a car. This non-invasive treatment approach provides an alternative to currently used colic treatment modalities (such as drugs or others). The research literature and clinical observation indicates that a rhythmic, rocking motion or rocking/vibration has a soothing effect on fussiness and distress in infants. Many pediatric texts recommend easing colicky episodes in infants by a rocking or rhythmic motion. The pilot project showed that the supplementary use of auditory stimulation could soothe colicky behavior. In addition, researchers have reported the soothing quality of auditory stimulation, so this treatment condition was incorporated into the research design. Purposes of the Project: 1) to demonstrate the effectiveness of a non-invasive motion simulation and sound treatment to reduce symptoms of infant colic; and 2) to demonstrate a reduction in mothers' stress level when the treatment is employed. The Infant-Colic Research Project conducted two experiments described below: Experiment I. The purpose of Experiment I (60 subjects) was to determine the effectiveness of motion simulation on reducing/relieving symptoms of infant colic. Two levels of motion simulation were tested. In addition, auditory stimulation was systematically introduced to determine whether or not sound also facilitated the treatment. A 2x2 factorial analysis of variance design with repeated measures was used to analyze the time-sampled behavioral measures of infant response. Colic Defined. One of the most common problems encountered in pediatric practice today is fussiness and colic in young infants. Although colic is difficult to define, it is perceived as unexplained paroxysms of irritability, fussing, crying, and often sustained screaming accompanied by indications of colonic peristalsis (Paradise, 1966). The symptoms usually start after feeding; they may occur in regular 24-hour cycles that are quite predictable; symptoms are reported to be worse late in the day (Glasser, et al., 1956). The pediatric text authored by Kempe, Silver and O'Brien, (1978), presents a typical description: "Colic or paroxysmal fussing is a common problem in young infants. It is most common in the evening. It may build up in a crescendo, with the baby drawing his/her legs up onto his/her abdomen, and is frequently relieved by the passage of flatus. This period usually begins at age two to three weeks and disappears by ten to twelve – so called "three-month colic." The course is not clear, but "developmental colic" may be related to overready response to stimulation, irregular gastrointestinal peristalis, and other as yet unintegrated autonomic functions characteristic of the first two to three months." (p.55) Colic Severity Rating Scale. Observations of the severity of colic behavior were conducted using the direct interval recording method. Eighty-four observations were taken on each subject over the course of 21 minutes. The first three minutes were a pre-treatment (baseline) period, followed by a 15-minute treatment and then a 3-minute post-treatment period. Scores on each observation for each 15-second interval were used to generate a daily profile for each subject using a classic ABA single subject research design. The colic severity score for each 15-second interval was derived in the following way: 1) The infants' sound level was observed and rated; If no sounds were made, the behavior was scored 0. If the sounds were fuss, the behavior was scored 1. If the sounds were cry, the behavior was scored 2. If the sounds were wails, the behavior was scored 3. (Behavioral descriptions are available for each sound rating.) 2) The infants' colic movements were observed and scored as present or absent (behavioral definition available): A. Arms/hands 1/0 B. Arching of back 1/0 C. Legs drawn up 1/0 3) The sound rating score was then added to any presence of these colic movement scores so that in any given 15 second interval the colic severity score can range between zero and six with six equaling intense colic and zero equaling no colic. Interrater Agreement : For the purpose of this study, interrater agreement was defined as two raters independently scoring their infant over 84 consecutive 15-second time periods. This agreement was established in a range between 92 percent and 99 percent with a median of 97 percent between each pair of trainees and trainer. Experimental Design The research design for Experiment I was a 2x2 factorial design with repeated measures where the independent variables consisted of two levels of motion simulation and two levels of auditory stimulation.   Sound No Sound   High Motion Simulation N = 15 N = 15   Low Motion Simulation N =15 N = 15         N = 60 The design incorporated random assignment of 15 colicky infants to each of the cells for a total of 60 subjects. The repeated measures occurred in two ways. First, each subject was observed on four separate days over a two-week period. Each observation was designed such that the infant was experiencing a colic episode when the observation began. Second, within each observation period, a total of 84, 15-second behavioral observations were made according to the procedures described below. Procedure The experimental procedure consisted of three phases; baseline, treatment and post-treatment. During baseline, the colicky infant, displaying observable signs of colic, was placed in the center of the crib. The infant was observed for three minutes according to the protocol described above. This baseline period was followed by a 15-minute treatment period where one level of motion simulation with or without sound was introduced for the entire treatment period. Each experimental motor was constructed such that only one level of motion simulation was possible with any given motor. For those subjects receiving the sound condition, the sound was preset by the audiologist using a sound meter when the box was fixed to the infants crib. The sound switch was activated during the treatment phase. Immediately following the treatment phase the motion simulator and sound box (if sound was used) were deactivated during a three minute, post-treatment observation phase. Neither parents nor observers were able to alter the frequency and amplitude of the motion simulator or the sound level of the sound box. Results Colic severity data from each of 60 children were collected and analyzed using a repeated measures analysis of variance. To simplify presentation, the data for each 15-second interval was averaged by minute across the three minutes of baseline, 15 minutes of treatment and three minutes of post-treatment baseline for four separate days of observation. This yielded 21 data points per day for a total of 84 data points. Obviously many different analyses were conducted on these data and the results presented here convey an overall picture. Figure 1 presents a profile of one child on one day for one treatment where the behavior of the child is reported every 15 seconds. Table 1 illustrates the 60 subject breakdown: Table 1 MEAN PRE-TREATMENT, TREATMENT AND POST-TREATMENT SCORE FOR MOST EFFECTIVE AND OVERALL CONDITIONS   Subjects Pre-Treatment Mean Treatment Mean Post-Treatment Mean Low Vibration / Sound 15 3.61 .91 1.51 Total All Groups 60 3.57 1.77 1.72 The overall results (Table 1) showed a significant decrease between the pre-treatment (colic) scores and the colic scores during the treatment of motion simulation. The difference between the overall pre-treatment mean (3.57) and the treatment mean (1.77) is 1.80, which was statistically significant at the p < .01 level. Thus, there was effectiveness for the motion simulator, which decreased colic severity. There was also an effect for the sound condition. The number of children who show a decrease of some kind between pre-treatment and treatment reinforces this finding. The treatment demonstrating the greatest effectiveness is low vibration and sound which on the average takes an infant experiencing a colic episode to a quiet state. Table 2 presents the repeated measures analysis of variance. Figures 2 and 3 graphically demonstrate the low vibrator/sound treatment condition and all treatment conditions respectively over the four days of the study. Fifty-eight of the 60 infants (97%) decreased their colic score at least one point from pre-test to treatment. These infants also had an increase in post-treatment colic behavior, but not nearly to the pre-treatment level. (See Tables 3 and 4) In summary, the motion simulator, irrespective of treatment mode, lessened colicky behavior based on differences between means and based on the proportion of infants showing improvement. Also, the Low MS with Sound was more effective than the other three treatment modes in lessening symptoms of infant colic. Experiment II In addition to the 60 infants required for Experiment I, an additional 40 subjects were used for Experiment II. The treatment, based on results from Experiment I, used a low vibration motor plus sound. Following a standard protocol of three days of baseline, 10 days of treatment, and three days of post-treatment, the mothers' stress level was monitored. During the 16 days of the experiment, a short five item questionnaire was administered four times; once prior to the start of the treatment days, twice during the treatment days, and once after the treatment days. Results. Results of the study indicated that the mother reported a high stress level prior to treatment. This was reflected in the reported stress level during the three days of baseline data. However, the reported stress level of the mother decreased substantially over the ten-day treatment period as the low motion simulation and sound reduced the infants' colic behavior. There was direct concomitant variation between the infant colic behavior and the level of the mothers' reported level of stress. Following 10 days of treatment, the level of the mothers' reported stress continued to be monitored. With no treatment in place, there was a systematic rise in the stress level. (See Figure 4 and Table 5) These data were analyzed using a one-way repeated measures analysis of variance. A statistically significant difference was found (p < .0001) among the times of measurement. A significant quadratic trend was also found in these data (p < .0001). (See Table 6) The study was completed in September 1986. Research Conducted By: The Infant Colic Research Project, D.B.A. Sweet Dreems, Inc., 300 E. Wilson Bridge Road, Worthington, Ohio 43085. Copyright 1986 Sweet Dreems, Inc., Worthington, Ohio. All rights reserved. Not to be copied or quoted without prior written permission from copyright owner Sweet Dreems, Inc. 4/87/176 TABLE 2 ANALYSIS OF VARIANCE OF COLIC SEVERITY SCORES FOR SOUND AND VIBRATION USING DAY AND MINUTE AS REPEATED MEASURES   Mean Square degrees of freedom F ratio Probability Greenhouse Geisser Probability Sound Vibration Sound &Vibration Error 128.34 491.72 8.77 43.10 1 1 1 56 2.98 11.41 20 .09 .001 .65 Day Day Sound Day Vibration Day Sound & Vibration Error 39.38 7.65 22.38 3.09 18.47 3 3 3 3 168 2.13 .41 1.21 .17 .10 .74 .31 .92   Minute Minute Sound Minute Vibration Minute Sound & Vibration Error 134.23 6.67 7.24 .62 2.07 20 20 20 20 1120 64.94 3.23 3.50 .30 .00001 .00001 .00001 .99 .0001 .01 .006 Day Minute Day Minute Sound Day Minute Vibration Day Minute Sound & Vibration Error .93 .86 1.67 1.24 1.40 60 60 60 60 3360 .67 .61 1.19 .88 .98 .99 .15 .72 TABLE 3 PERCENT OF INFANTS DEMONSTRATING A REDUCTION IN COLIC SYMPTOMS FROM BASELINE TO TREATMENT PHASE TREATMENT CONDITIONS   Low Vibration No Sound Low Vibration Sound High Vibration No Sound High Vibration Sound Total N 15 15 15 15 60 Percent Achieving Postive Change 93% 100% 93% 100% 97% Average Amount of Change (Baseline Treatment) 2.08 2.70 1.23 1.85 1.96 TABLE 4 AVERAGE TIME TO GO TO QUIET, RESTFUL STATE PER TREATMENT AND POST TREATMENT   Low Vibration No Sound Low Vibration Sound High Vibration No Sound High Vibration Sound Total # Of Days Observed 60 60 60 60 240 # of Times Infant Went to Quiet, Restful State During Treatment 50 57 39 38 184 ( 77% ) # of Times Infant Remaind Quiet, Restful During Post-Treatment 35 29 35 24 123 ( 51% ) Average Duration (In Minutes) of Treatment Until Quiet, Restful State Induced 4.17 2.77 5.49 4.39 4.08 * Quiet Restful State was defined as four consecutive observation periods of no sounds and no colic behavior movements. TABLE 5 MOTHERS' AVERAGE STRESS SCORES DURING PRE-TREATMENT, TREATMENT, AND POST-TREATMENT   Pre-Treatment Mean Early Treatment Mean Later Treatment Mean Post-Treatment Mean Total Stress Score * N = 40 17.42 12.71 10.95 13.57 * Total stress scores range from 25 (highest stress) to 5 (no stress). TABLE 6 RESULTS OF ONE-WAY ANOVA ON MOTHERS' STRESS SCORES ACROSS THE PRE-TREATMENT, TREATMENT, AND POST-TREATMENT PERIODS INCLUDING QUADRATIC ANALYSIS RESULTS Type of Score Mean Square Mean Square Error degrees of freedom F ratio probability < Value Total Stress Score 314.09 13.89 3.123 22.60 .00001 Quadratic 564.67 13.50 1.41 41.80 .00001 Figure 1 Figure 2 Figure 3 Figure 4

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