Therapeutic Touch in Premature Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapeutic Touch: Therapeutic Touch will be administered by the researcher to preterm infants in the intervention group under controlled environmental conditions. The care environment will be quiet, warm, and free from distracting stimuli, and infants will be positioned in a supine position for safe observation. The intervention will consist of gentle, stable, and rhythmic hand contact applied to the head, trunk, arms, and legs to promote relaxation and comfort. Therapeutic Touch will be applied twice daily for five consecutive days, with each session lasting approximately one minute. During the intervention, heart rate, respiratory rate, and oxygen saturation will be continuously monitored. Infants in the control group will receive routine neonatal care only.

Study summary

Preterm birth is associated with increased physiological instability, stress responses, and developmental vulnerability due to immature organ systems and prolonged exposure to invasive procedures and environmental stressors in neonatal intensive care units (NICUs). In recent years, non-pharmacological, touch-based interventions have gained attention for their potential to support neurodevelopment, improve comfort, and stabilize physiological parameters in preterm infants.

Therapeutic Touch (TT) is a non-invasive, holistic intervention based on the modulation of the human energy field through gentle hand movements, aiming to reduce stress, promote relaxation, and support physiological regulation. Although TT has demonstrated beneficial effects in various populations, evidence regarding its effects on preterm infants remains limited.

This randomized controlled study aims to evaluate the effects of Therapeutic Touch on behavioral responses, comfort levels, and physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) in preterm infants hospitalized in the NICU. The findings are expected to contribute evidence for safe, supportive, and holistic neonatal care practices.

Eligibility

Primary outcome measure(s)

• Neonatal Comfort Level — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  The primary outcome of this study is the neonatal comfort level of preterm infants. Comfort will be assessed using a validated neonatal comfort scale. Measurements will be obtained at baseline and after completion of the 5-day Therapeutic Touch intervention period. Lower total scores indicate higher levels of comfort. For analysis, comfort scale scores will be compared between the Therapeutic Touch and control groups.
• Behavioral Responses — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  Behavioral responses of preterm infants will be assessed using a standardized neonatal behavioral assessment scale. Measurements will be obtained at baseline and after completion of the 5-day Therapeutic Touch intervention period. Lower scores indicate more positive behavioral states, while higher scores indicate negative behavioral responses. For analysis, behavioral assessment scale scores will be compared between the Therapeutic Touch and control groups.
• Heart Rate — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  Heart rate (beats per minute) will be measured using standard bedside monitors. Measurements will be obtained immediately before, during, and after each Therapeutic Touch session across the 5-day intervention period. For analysis, heart rate values will be summarized as mean values over the intervention period, and the post-intervention heart rate will be compared between the Therapeutic Touch and control groups.
• Respiratory Rate — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  Respiratory rate (breaths per minute) will be measured using standard bedside monitors. Measurements will be obtained immediately before, during, and after each Therapeutic Touch session across the 5-day intervention period. For analysis, respiratory rate values will be summarized as mean values over the intervention period, and the post-intervention respiratory rate will be compared between the Therapeutic Touch and control groups.
• Oxygen Saturation — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  Oxygen saturation (%) will be continuously monitored using pulse oximetry. Measurements will be obtained immediately before, during, and after each Therapeutic Touch session across the 5-day intervention period. For analysis, oxygen saturation values will be summarized as mean values over the intervention period, and post-intervention oxygen saturation levels will be compared between the Therapeutic Touch and control groups.
• Blood Pressure — Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
  Blood pressure (mmHg) will be measured using standard neonatal blood pressure monitoring methods. Measurements will be obtained immediately before, during, and after each Therapeutic Touch session across the 5-day intervention period. For analysis, blood pressure values will be summarized as mean values over the intervention period, and post-intervention blood pressure values will be compared between the Therapeutic Touch and control groups.

Trial sites (1)

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