Frequent regurgitation and/or vomiting is the most common infant problem handled in pediatric practices, affecting about 1.2 million infants annually in the US. Regurgitation in infants is typically attributable to gastroesophageal reflux (GER), the involuntary passage of gastric contents into the esophagus. Frequent regurgitation, irritability, feeding difficulties, apnea and cyanosis are symptoms of more complicated GER, a condition called gastroesophageal reflux disease (GERD).This disorder can be extremely distressful to both infants and caretakers and can interrupt sleep and impair nutrition. Common pharmacological treatments are only partially effective and have side effects. Other risks from GERD include exacerbation of acid reflux, esophagitis, and disturbed mother-infant relationships. Massage Therapy (MT) is known to promote sleep and relaxation and holds promise as a safe and effective treatment for GERD symptoms in infants. Although MT has been used with infants, it is a novel approach for treating GERD. In this proposed randomized control trial, the effects of massage therapy (MT) versus a non-massage therapy (NMT) sham treatment will be compared. The central aim of this study is to evaluate the clinical efficacy of Massage Therapy (MT) on GERD symptoms by testing this central hypothesis: GERD Symptoms will be lower in infants who receive MT treatments than in infants who receive (NMT) sham treatments. Secondary aims will evaluate the clinical efficacy of MT on weight gain, sleep, and post treatment and daily cortisol secretion. Forty 6 to10 week-old infants will be recruited from pediatric practices serving diverse populations. After potential subjects are screened for GERD with the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R), infants with GERD will be randomly assigned to MT or NMT. The MT group will receive 30-minute MT treatments bi- weekly for 6 weeks by experienced massage therapists. The NMT group will receive the same number of sham treatments on the same schedule given by a health professional without massage experience. Data collection will take place at baseline and 4 and 6 weeks after treatment begins. The instrument for the central hypothesis is the I-GERQ-R to monitor GERD symptoms. Variables for the secondary hypotheses will be measured by monitoring infant weights and using actimetry to measure sleep. Salivary cortisol will be measured pre and post treatments, and daily cortisol secretion will be obtained from aggregation of salivary cortisol levels collected thrice daily for three days at each assessment. Another aim of this study is to evaluate the feasibility of testing MT as treatment for GERD (e.g., procedure fidelity, protocol adherence, blinding, safety, dose response, measurement adequacy, accrual rate, attrition rate). Various data collecting forms will facilitate recording all critical feasibility aspects of the research design and methods. Analysis of the hypotheses for Aims 1 to 3 will be repeated measures ANCOVA to compare groups and to assess change. Descriptive statistics, rate calculations, and field note analyses will used for evaluation of feasibility.
Frequent regurgitation and/or vomiting is the most common infant problem handled in pediatric practices, affecting one-third of all infants (approximately 1.2 million infants in the United States). A complication of regurgitation in infants is gastroesophageal reflux disease (GERD) with symptoms of frequent regurgitation, irritability, feeding difficulties, apnea and cyanosis. This study examines the effectiveness of using massage therapy to improve infant health by reducing GERD symptoms.
| Neu, Madalynn; Pan, Zhaoxing; Workman, Rachel et al. (2014) Benefits of massage therapy for infants with symptoms of gastroesophageal reflux disease. Biol Res Nurs 16:387-97 |
| Neu, Madalynn; Corwin, Elizabeth; Lareau, Suzanne C et al. (2012) A review of nonsurgical treatment for the symptom of irritability in infants with GERD. J Spec Pediatr Nurs 17:177-92 |
