NCT07363785

Therapeutic Touch in Premature Infants

The Effects Of Therapeutic Touch Applied To Premature Infants On Behavioural Responses, Comfort And Physiological Parameters: A Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Selcuk University · Academic / Other
• Sex: All
• Age: 28 Weeks – 37 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

Preterm birth, defined as delivery before 37 completed weeks of gestation, remains a major global public health concern and is associated with increased neonatal morbidity and mortality. Due to the immaturity of physiological systems, preterm infants are particularly vulnerable to environmental stressors such as excessive noise, bright lighting, frequent handling, and invasive medical procedures commonly encountered in neonatal intensive care units (NICUs). These stressors may lead to physiological instability, altered behavioral responses, impaired neurodevelopment, and long-term cognitive and emotional difficulties. In addition to ensuring survival, contemporary neonatal care emphasizes supporting long-term growth, neurodevelopment, and well-being while minimizing stress and discomfort. Non-pharmacological interventions, particularly touch-based approaches, have gained prominence as safe and developmentally supportive strategies. Therapeutic Touch (TT) is a holistic nursing intervention based on the theory that the human body is surrounded by a dynamic energy field that can be balanced through intentional, gentle hand movements without invasive contact. TT has been reported to reduce pain, anxiety, and stress, while promoting relaxation and physiological stability in various patient populations. Despite increasing interest in integrative and supportive neonatal care practices, randomized controlled trials evaluating the effects of Therapeutic Touch on preterm infants are scarce. Existing studies suggest that touch-based interventions may improve behavioral regulation, reduce stress hormone levels, support weight gain, and shorten hospital stays. However, evidence specifically addressing the impact of Therapeutic Touch on behavioral responses, comfort, and core physiological parameters in preterm infants remains limited. This randomized controlled trial aims to systematically evaluate the effects of Therapeutic Touch administered by a trained practitioner on preterm infants hospitalized in the NICU. Outcomes will include behavioral responses, comfort levels, and physiological parameters such as heart rate, respiratory rate, oxygen saturation, and body temperature. By providing rigorous evidence on the safety and effectiveness of Therapeutic Touch in neonatal care, this study seeks to support the integration of holistic, non-pharmacological interventions into routine NICU practice and contribute to improved health and well-being outcomes for preterm infants.

Conditions

• Premature Infants

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)