Therapeutic Touch in Premature Infants

January 14, 2026 updated by: Habibe BAY, Selcuk University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic Touch group
The babies in the intervention group will receive therapeutic touch twice a day, morning and evening, for one minute each time, for five days.
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.
No Intervention: Routine care group
Infants in the control group will continue with their routine clinical treatment and care without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Comfort Level
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Behavioral Responses
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Heart Rate
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Respiratory Rate
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Oxygen Saturation
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Blood Pressure
Time Frame: 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.
Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Principal Investigator: HABIBE BAY ÖZÇALIK, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/1144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Infants

Clinical Trials on Therapeutic Touch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe