Premature InfantsNCT07322731
The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants
A study testing Infant Massage Therapy in people with Premature Infants and Sleep Quality, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Read more about this study
- Who is it for?
- Ages 35 to 37 months
- Conditions the study is for
- Premature Infants, Sleep Quality, İnfant Stress
- What is being tested?
- Infant Massage Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Jun 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 35 to 37 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born between 35-37 weeks gestational age.
- Admitted to the neonatal intensive care unit (NICU).
- Medically stable and cleared for massage therapy by neonatologist.
- Parental/guardian consent obtained.
Who cannot join
- Infants with congenital anomalies or major medical complications.
- Infants requiring mechanical ventilation or intensive respiratory support.
- Infants with known neurological disorders.
- Parental/guardian refusal or inability to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Regional Training and Research Hospital
Van, Turkey, 65090
RIDVAN AKDOĞAN, Assist. Prof. (PhD), 05413983680, ridvanakdogan@yyu.edu.tr
About this study
Official title: The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.
Read the detailed description
This randomized controlled study evaluates the impact of massage therapy on preterm infants' sleep quality, stress levels, comfort, and vital signs in the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants born between 35 and 37 weeks of gestation and meeting inclusion criteria will be randomly assigned to either an intervention group receiving massage or a control group receiving standard care.
The intervention consists of a 15-minute massage administered three times daily for three consecutive days by a trained researcher. Massage includes gentle stroking and circular movements of the legs, arms, back, and hands, following a standardized protocol. Physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation), sleep patterns (using actigraphy and chronometer), and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale will be recorded before and after the intervention.
Data will be analyzed using SPSS version 25. Group homogeneity will be assessed with chi-square or Fisher's exact tests, within-group comparisons with paired t-tests, and between-group comparisons with independent t-tests. Significance will be set at p < 0.05. This study aims to provide evidence on the efficacy of massage therapy as a non-pharmacological intervention to improve preterm infants' comfort, reduce stress, and enhance sleep quality in NICU settings.
- Conditions
- Premature Infants, Sleep Quality, İnfant Stress, İnfant Comfort, Vital Signs, NICU
- Being tested
- Infant Massage Therapy
- Keywords
- Preterm infants, neonatal massage, NICU, sleep quality, stress reduction, comfort, vital signs
- Medical subject headings
- Premature Birth, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Massage TherapyOther
Preterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Preterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care. Receives: Other: Infant Massage Therapy |
| Control - Standard Care | No intervention | Preterm infants receiving standard care only, without massage intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality of Preterm Infants
Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.
Measured: Measured daily over 3 days of massage intervention
Secondary outcomes (5)
Infant Comfort Level
Measured using Premature Infant Comfort Scale , higher scores indicate lower comfort.
Measured: Assessed before first massage and after last massage session (Day 3)
Infant Stress Levels
Measured using Neonatal Stress Scale; higher scores indicate greater stress.
Measured: Assessed before first massage and after last massage session (Day 3)
Heart Rate of Preterm Infants During Massage Therapy
Heart rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. Unit of measure: beats per minute (bpm).
Measured: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Respiratory Rate of Preterm Infants During Massage Therapy
Respiratory rate will be measured using a bedside monitor as an indicator of physiological response to massage therapy. The outcome will be expressed as breaths per minute.
Measured: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Oxygen Saturation of Preterm Infants During Massage Therapy
Oxygen saturation will be measured noninvasively using pulse oximetry to assess physiological response to massage therapy. The outcome will be expressed as percentage (%).
Measured: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Aug 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 Jun 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the intervention group, which receives massage therapy, or the control group, which receives standard care. Randomization is performed using the Urn method. Each participant is assigned to only one group (parallel design). The intervention is applied three times daily for 15 minutes over three consecutive days.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rıdvan Akdogan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322731
- Sponsor's protocol ID
- YUZUNCU_YIL_UNIVERSITY_NICU
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to researchers. Data will be accessible starting 6 months after publication of the primary results and will remain available for 5 years.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage on Sleep Quality, Stress, Comfort, and Vital Signs in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07322731
- Acronym / sponsor ID
- YUZUNCU_YIL_UNIVERSITY_NICU
- Conditions
- Premature Infants, Sleep Quality, İnfant Stress, İnfant Comfort, Vital Signs, NICU
- Keywords
- Preterm infants, neonatal massage, NICU, sleep quality, stress reduction, comfort, vital signs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 7 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.
This randomized controlled trial investigates the effects of massage therapy on sleep quality, stress, comfort, and vital signs in preterm infants (gestational age 35-37 weeks) admitted to the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants in the intervention group will receive a 15-minute massage three times a day for three consecutive days, while the control group will receive standard care. Data will be collected using the Premature Infant Comfort Scale, Neonatal Stress Scale, actigraphy for sleep monitoring, and vital sign measurements. The study aims to determine whether massage therapy can improve the overall well-being and development of preterm infants in NICU settings.
Detailed description
This randomized controlled study evaluates the impact of massage therapy on preterm infants' sleep quality, stress levels, comfort, and vital signs in the Neonatal Intensive Care Unit (NICU) at Van YYU Training and Research Hospital. Infants born between 35 and 37 weeks of gestation and meeting inclusion criteria will be randomly assigned to either an intervention group receiving massage or a control group receiving standard care.
The intervention consists of a 15-minute massage administered three times daily for three consecutive days by a trained researcher. Massage includes gentle stroking and circular movements of the legs, arms, back, and hands, following a standardized protocol. Physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation), sleep patterns (using actigraphy and chronometer), and behavioral assessments using the Premature Infant Comfort Scale and Neonatal Stress Scale will be recorded before and after the intervention.
Data will be analyzed using SPSS version 25. Group homogeneity will be assessed with chi-square or Fisher's exact tests, within-group comparisons with paired t-tests, and between-group comparisons with independent t-tests. Significance will be set at p < 0.05. This study aims to provide evidence on the efficacy of massage therapy as a non-pharmacological intervention to improve preterm infants' comfort, reduce stress, and enhance sleep quality in NICU settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the intervention group, which receives massage therapy, or the control group, which receives standard care. Randomization is performed using the Urn method. Each participant is assigned to only one group (parallel design). The intervention is applied three times daily for 15 minutes over three consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Infant Massage TherapyPreterm infants receiving massage therapy three times daily for 15 minutes over 3 days, in addition to standard care. |
| Control - Standard Care | No intervention | –Preterm infants receiving standard care only, without massage intervention. |
Who may qualify
- Ages
- 35 to 37 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infants born between 35-37 weeks gestational age.
- Admitted to the neonatal intensive care unit (NICU).
- Medically stable and cleared for massage therapy by neonatologist.
- Parental/guardian consent obtained.
Key exclusion criteria (4 listed)
- Infants with congenital anomalies or major medical complications.
- Infants requiring mechanical ventilation or intensive respiratory support.
- Infants with known neurological disorders.
- Parental/guardian refusal or inability to participate.
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 |
|---|---|---|
| Infant Massage TherapyPreterm infants receive a standardized massage therapy protocol three times daily for 15 minutes over 3 days. The massage is applied by a trained nurse and includes legs, arms, and back following a structured sequence. | Other | Experimental Group |
Primary outcome
Sleep Quality of Preterm Infants
Time frame: Measured daily over 3 days of massage intervention
Sleep duration and awakenings assessed using actigraphy and researcher observation before and after massage sessions.
5 secondary outcomes
Infant Comfort Level
Time frame: Assessed before first massage and after last massage session (Day 3)
Infant Stress Levels
Time frame: Assessed before first massage and after last massage session (Day 3)
Heart Rate of Preterm Infants During Massage Therapy
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Respiratory Rate of Preterm Infants During Massage Therapy
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
Oxygen Saturation of Preterm Infants During Massage Therapy
Time frame: Baseline (prior to the first massage session) and immediately after each massage session over 3 days
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 7 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data, along with the study protocol and statistical analysis plan, will be made available upon reasonable request to researchers. Data will be accessible starting 6 months after publication of the primary results and will remain available for 5 years.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Massage Therapy in people with Premature Infants and Sleep Quality, run by Yuzuncu Yil 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 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 RIDVAN AKDOĞAN, PhD (+905413980680, ridvanakdogan@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality of Preterm Infants (time frame: Measured daily over 3 days of massage intervention). 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 7 Jan 2026.