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
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedJanuary 23, 2026
January 1, 2026
3 months
January 6, 2026
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Oxygen Saturation
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Blood Pressure
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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Study Arms (2)
Therapeutic Touch group
EXPERIMENTALThe babies in the intervention group will receive therapeutic touch twice a day, morning and evening, for one minute each time, for five days.
Routine care group
NO INTERVENTIONInfants in the control group will continue with their routine clinical treatment and care without any intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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,
- Stable health status will be included in the study.
You may not qualify if:
- Infants with:heart disease,
- congenital anomalies,
- skin health problems,
- neurological diseases,
- mechanical ventilation,
- those receiving continuous opioid, sedative, anticonvulsant or corticosteroid treatment,
- active infection or antibiotic treatment,
- undergoing surgery will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Habibe Bay Ozcalik
Konya, 42250, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HABIBE BAY ÖZÇALIK
associate professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
January 6, 2026
First Posted
January 23, 2026
Study Start
January 30, 2026
Primary Completion
April 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly shared during the study period. After completion of the study, de-identified data may be shared with other researchers for scientific purposes upon reasonable request, in accordance with ethical regulations and institutional policies.