Premature InfantsNCT07363785
Therapeutic Touch in Premature Infants
A study testing Therapeutic Touch in people with Premature Infants, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants
- What is being tested?
- Therapeutic Touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Therapeutic Touch
- Keywords
- Preterm Infant, Therapeutic Touch, Behavioral Responses, Neonatal Comfort, Physiological Parameters
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchBehavioural
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 group | Role | What they receive |
|---|---|---|
| Therapeutic Touch group | Experimental | The babies in the intervention group will receive therapeutic touch twice a day, morning and evening, for one minute each time, for five days. Receives: Behavioral: Therapeutic Touch |
| Routine care group | No intervention | Infants in the control group will continue with their routine clinical treatment and care without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe BAY, Selcuk University
- Investigators
- HABIBE BAY ÖZÇALIK, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363785
- Sponsor's protocol ID
- 2025/1144
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Therapeutic Touch Applied To Premature Infants On Behavioural Responses, Comfort And Physiological Parameters: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07363785
- Acronym / sponsor ID
- 2025/1144
- Conditions
- Premature Infants
- Keywords
- Preterm Infant, Therapeutic Touch, Behavioral Responses, Neonatal Comfort, Physiological Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Touch group | Experimental | Behavioral: Therapeutic TouchThe 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 intervention | –Infants in the control group will continue with their routine clinical treatment and care without any intervention. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Infants with:heart disease,
- congenital anomalies,
- skin health problems,
- neurological diseases,
- mechanical ventilation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic TouchTherapeutic 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. | Behavioural | Therapeutic Touch group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HABIBE BAY ÖZÇALIK principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Touch in people with Premature Infants, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HABIBE BAY ÖZÇALIK (05424469643, habiberk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Comfort Level (time frame: Baseline (prior to first intervention session) and Day 5 (after completion of the 5-day intervention period)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.