This randomized controlled trial enrolled 96 infants aged 4 to 8 weeks who met Rome IV criteria for infantile colic. Participants were assigned to receive therapeutic touch based on Watson's Human Care Theory (3 times per week for 1 or 2 weeks) or usual care only. The study was conducted in a hospital outpatient pediatric unit.
The primary outcome was crying time. Infants receiving therapeutic touch showed statistically significant reductions in crying compared with the control group (group × time interaction: F = 222.612; p < .001; η² = 0.827). Secondary outcomes included sleep time and Infant Colic Scale (ICS) scores, both of which also improved significantly (sleep: F = 47.244; p < .001; η² = 0.504; ICS: F = 219.247; p < .001; η² = 0.825). All effect sizes were large. Absolute crying and sleep times were not reported.
Safety and tolerability were not reported, and no adverse events or discontinuations were mentioned. The study did not report funding or conflicts of interest. Limitations include lack of blinding, small sample size, and absence of absolute outcome values, which limits clinical interpretability.
Clinicians should interpret these results cautiously. While therapeutic touch may offer a nonpharmacologic approach for infantile colic, the evidence is preliminary and requires confirmation in larger, blinded trials with standardized outcome measures.
View Original Abstract ↓
OBJECTIVE: We aimed to determine the effect of the different numbers of therapeutic touch sessions, based on Watson's Human Care Theory, on colic symptoms (crying time, sleep time, Infant Colic Scale [ICS]) in infants with infantile colic.
METHODS: This randomized controlled trial included 96 infants aged 4 to 8 weeks who met Rome IV criteria for infantile colic in a hospital outpatient pediatric unit. Infants were randomly assigned into 3 groups: intervention 1 (therapeutic touch for 1 week, n = 32), intervention 2 (therapeutic touch for 2 weeks, n = 32), and control (usual care only, n = 32). In both intervention groups, therapeutic touch was administered in addition to usual care, 3 times per week. Data were collected at baseline and at the 1st, 2nd, 4th, and 8th weeks. The primary outcome was crying time; secondary outcomes were sleep time and ICS Score.
RESULTS: There were statistically significant differences among the groups' crying times ( = 222.612; < .001; = 0.827), sleep times ( = 47.244; < .001; = 0.504), and ICS total scores ( = 219.247; < .001; = 0.825). When infants in intervention groups were compared with the control group infants, the effect size (group × time interaction) was large. Infants receiving therapeutic touch showed reductions in crying and improvements in sleep compared with those receiving usual care. Infants in the 2-week therapeutic touch group demonstrated greater and longer-lasting benefits than those receiving therapeutic touch for 1 week.
CONCLUSIONS: Therapeutic touch based on Watson's Human Care Theory effectively reduced colic symptoms in infants, with greater benefits observed as the number of sessions increased.
TRIAL REGISTRATION: clinicaltrials.gov, NCT05244291.