Therapeutic Touch in Premature Infants
ConditionPremature Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-37
SponsorSelcuk University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Infants with a gestational age between 28-37 weeks,
Birth weight of 1500 gr and above,
Post-feeding,
Hospitalized in Level 1 or Level 2 NICU,
Disqualifiers
Infants with:heart disease,
congenital anomalies,
skin health problems,
neurological diseases,
Trial design
Design model
Parallel
Treatments tested in this trial
Therapeutic Touch
BehavioralTherapeutic 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Therapeutic Touch groupExperimental treatment 1 intervention
Group B: Routine care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neonatal Comfort Level
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.
Time frame
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)2
Behavioral Responses
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.
Time frame
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)3
Heart Rate
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.
Time frame
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)4
Respiratory Rate
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.
Time frame
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: