Jodi A. Mindell, PhD^a; Kathryn Luedtke^b; Diana L. Friscia^b; Jean Holland^b; Benjamin Wiegand, PhD^b

^aSaint Joseph's University; Sleep Center at The Children's Hospital of Philadelphia
^bJohnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc.

Introduction

Sleep problems are one of the most common complaints by parents of infants to pediatricians. A recent United States survey found that 76% of parents reported that they would like to change some aspects of their child's sleep habits¹. In addition, studies indicate that 25% to 30% of infants experience some type of sleep problems². Establishing a consistent before-bed routine is often recommended to parents of infants, especially those with sleep difficulties. However, no studies have evaluated the clinical benefits of such routines. Furthermore, parents are often unsure about what constitutes a 'good routine' and how to help improve their child's sleep³.

This study evaluated the effects of a proprietary product-based, before-bed routine on both infants' sleep and maternal mood.

Study Objective

The objective of this clinical study was to examine the effects of a consistent before-bed routine that included the use of a baby bath and lotion on infants' sleep. The baby bath and lotion provided contained a proprietary blend of essences (patent pending) shown to calm and relax. The study also examined the impact of this before-bed routine on maternal mood.

Study Design

Fifty eight (58) healthy infants less than 2 years of age and their mothers participated in a multiweek clinical study. Parents engaged in their infant's usual nighttime routine during baseline data collection. Following baseline, parents were instructed to engage in a nightly before-bed routine using a provided baby bath and lotion. Each mother reported on her infant's sleep using clinically validated psychometric measures. They also reported on their own mood states using a validated psychometric tool. Clinical exclusion criteria included a significant sleep disorder or medical issue based on maternal report.

Before-Bed Routine - Mothers were instructed to bathe their infant using the baby bath, followed by a massage using the lotion. Mothers were then instructed to engage in quiet activities before putting their infant to bed.

Clincial Measures - All mothers completed daily, validated questionnaires regarding their infant's sleep and their own mood. In addition, mothers completed a questionnaire regarding their perception of how easy it was to put their infant to bed, and how well their infant slept.

Results

Results indicate that infant sleep improved

Using the baby bath and lotion as part of a before-bed routine significantly decreased sleep-onset latency (the time to fall asleep) compared with baseline. Additionally, there were significantly fewer night wakings, decreased wakefulness after sleep onset, and longer continuous sleep compared with baseline. Furthermore, there was a significant reduction in the percentage of mothers who classified their infant's sleep as a 'problem'.

Mothers also reported significant improvements in their infant's sleep. There was a significant increase in the percentage of mothers reporting that 'putting baby to bed was easier' compared with baseline. Furthermore, the percentage of mothers reporting that their baby 'slept well' was more than doubled compared with baseline.

Results indicate benefits for mothers

The baby bath and lotion used as part of a before-bed routine resulted in significant improvements in maternal mood, including a significant reduction in tension and fatigue and an increase in vigor (energy) compared with baseline.

Conclusions

A. This study found that a consistent before-bed routine that included the use of a baby bath and lotion containing a proprietary blend of essences shown to calm and relax, resulted in a significant improvement in infants' sleep:

• Infants fell asleep faster (sleep-onset latency was reduced)
• Infants had decreased wakefulness after sleep onset (number / duration of night awakenings)
• Infants slept longer (continuous sleep)
• Infants' sleep improved (mother assessment)

B. In addition, this nightly before-bed routine resulted in benefits for mothers, with significant improvements in maternal mood:

• Mothers felt less tense
• Mothers felt less tired
• Mothers had more energy

C. Based on maternal reports, infants were also significantly 'easier to put to bed' and 'slept better' compared with baseline.

The proprietary before-bed routine evaluated in this clinical study provided mothers with an empirically supported approach for establishing a consistent before-bed routine to help their infant sleep better. Mothers who used this before-bed routine for their infant also saw benefits for themselves resulting in improved maternal mood. The results of this study provide healthcare professionals with evidence-based recommendations to help infants sleep better, and ensure a good night's sleep for the entire family.

Acknowledgements:

Ellen S. Kurtz, PhD and Lorena S. Telofski, Johnson & Johnson Consumer & Personal Products Worldwide, Division of Johnson & Johnson Consumer Companies, Inc.

References:

1. National Sleep Foundation. Sleep in America Poll. 2004.

2. Mindell JA, Kuhn B, Lewin DS, Meltzer LJ, Sadeh A. Behavioral treatment of bedtime problems and night wakings in infants and young children. Sleep. 2006;29:1263-1276.

3. Data on file, Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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