Neonatal HyperbilirubinemiaNCT07610811
Foot Reflexology and Massage in Neonates Receiving Phototherapy
A study testing Foot Reflexology, Body Massage and Phototherapy Device in people with Neonatal Hyperbilirubinemia, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns. Read more about this study
- Who is it for?
- Ages 2 to 10 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Foot Reflexology, Body Massage and Phototherapy Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2026to 8 May 2027
- 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 2 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates whose parents/legal guardians have signed the informed consent form and agreed to participate in the study
- Neonates born between 34 and 41 weeks of gestation
- Birth weight of 2500 g or above
- Not mechanically ventilated
- No nasogastric tube
- Stable vital signs
Show all 11Show fewer
- No elevated acute phase reactants during phototherapy treatment
- Indirect bilirubin level between 12 and 28 mg/dL at admission to the neonatal intensive care unit
- Not receiving antibiotic treatment during the study
- Aged between 2 and 10 days
- No health problems other than indirect hyperbilirubinemia.
Who cannot join
- Presence of any neurological anomaly
- Presence of any congenital anomaly
- Jaundice due to ABO incompatibility
- Jaundice due to Rh incompatibility
- Presence of dermal anomalies
- Diagnosis of hyperbilirubinemia within the first 24 hours after birth
- Diagnosis of direct hyperbilirubinemia
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
Kuşadası State Hospital
Kusadasi, Aydın, 09400
yağmur karadas, +90 5072209435, yagmurerisen@gmail.com
About this study
Official title: Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial
Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns.
This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy.
Read more
A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention.
The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.
Read the detailed description
Neonatal hyperbilirubinemia is one of the most common conditions requiring hospitalization in the early neonatal period. Although phototherapy is the standard treatment, it may be associated with potential short- and long-term adverse effects, including dehydration, thermoregulation disturbances, and increased stress responses. Therefore, there is growing interest in complementary, non-invasive interventions that may enhance treatment effectiveness and improve neonatal outcomes.
Massage therapy and foot reflexology are commonly used complementary interventions in neonatal care. These interventions are thought to stimulate the gastrointestinal system, increase bowel movements, and facilitate bilirubin excretion. In addition, they may contribute to improved physiological stability and reduced stress levels through tactile stimulation.
This study is designed as a randomized controlled trial to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters, and stress levels in neonates receiving phototherapy. Physiological parameters include heart rate, respiratory rate, oxygen saturation, and body temperature.
The study will be conducted in a neonatal intensive care unit and will include 105 neonates diagnosed with indirect hyperbilirubinemia. Participants will be randomly assigned to one of three groups: foot reflexology group, body massage group, and control group. Interventions will be administered prior to phototherapy sessions.
Data will be collected using standardized tools, including a Neonatal Information Form, Neonatal Follow-up Form, and a validated Neonatal Stress Scale. Outcome measures will be assessed before and after the interventions.
The findings of this study are expected to provide evidence on the effectiveness of complementary non-pharmacological interventions in reducing bilirubin levels, improving physiological stability, and decreasing stress in neonates. These results may contribute to the integration of evidence-based complementary practices into neonatal care.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Foot Reflexology, Body Massage, Phototherapy Device
- Keywords
- Foot Reflexology, Neonatal Massage, Phototherapy, Neonate, Hyperbilirubinemia, Bilirubin, Non-pharmacological Intervention, Complementary Therapy, Neonatal Stress, Physiological Parameters
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyBehavioural
Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Body MassageBehavioural
Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Phototherapy DeviceDevice
Phototherapy will be provided using a standard phototherapy device according to the neonatal intensive care unit's routine clinical protocol for the management of neonatal indirect hyperbilirubinemia.
| Study group | Role | What they receive |
|---|---|---|
| Foot Reflexology Group | Experimental | Neonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions. Receives: Behavioral: Foot Reflexology |
| Body Massage Group | Experimental | Neonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions. Receives: Behavioral: Body Massage |
| Control Group | Active comparator | Neonates in this group will receive standard phototherapy care only without any additional intervention. Receives: Device: Phototherapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Serum Bilirubin Level
Total serum bilirubin level will be measured to evaluate the effect of foot reflexology and body massage on bilirubin reduction in neonates receiving phototherapy.
Measured: Immediately before and immediately after each phototherapy session.
Secondary outcomes (5)
Heart rate
Heart rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as beats per minute.
Measured: Immediately before and immediately after each phototherapy session.
Respiratory Rate
Respiratory rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as breaths per minute.
Measured: Immediately before and immediately after each phototherapy session.
Oxygen Saturation
Oxygen saturation will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as percentage oxygen saturation.
Measured: Immediately before and immediately after each phototherapy session.
Body Temperature
Body temperature will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported in degrees Celsius.
Measured: Immediately before and immediately after each phototherapy session.
Neonatal Stress Level
Neonatal stress level will be evaluated using the Newborn Stress Scale developed by Ceylan and Bolışık. This observational scale includes eight domains: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each domain reflects observable behavioral or physiological stress responses in the newborn, such as changes in facial expression, skin color, breathing pattern, motor activity, ability to be consoled, muscle tension, limb movements, and body posture. Items are scored from 0 to 2, with higher scores indicating a higher level of neonatal stress. The outcome will be reported as the total scale score.
Measured: Immediately before and immediately after each phototherapy/intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start9 May 2026
- Primary completion8 Mar 2027 (estimated)
- Study completion8 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Model description
- Participants will be randomly assigned to one of three parallel groups: foot reflexology group, body massage group, or control group. Each participant will remain in the assigned group throughout the study. The intervention groups will receive foot reflexology or body massage in addition to standard phototherapy care, while the control group will receive standard phototherapy care only.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yagmur karadas, Aydin Adnan Menderes University
- Investigators
- ayten taspinar, Professor, Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610811
- Sponsor's protocol ID
- 2025/008
- Status last verified
- Sep 2026
- First submitted
- 8 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations involving neonatal participants. Aggregated study findings may be shared through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07610811
- Acronym / sponsor ID
- 2025/008
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Foot Reflexology, Neonatal Massage, Phototherapy, Neonate, Hyperbilirubinemia, Bilirubin, Non-pharmacological Intervention, Complementary Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 9 May 2026 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 May 2027 (estimated)
- First posted
- 28 May 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.
Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns.
This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy.
A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention.
The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.
Detailed description
Neonatal hyperbilirubinemia is one of the most common conditions requiring hospitalization in the early neonatal period. Although phototherapy is the standard treatment, it may be associated with potential short- and long-term adverse effects, including dehydration, thermoregulation disturbances, and increased stress responses. Therefore, there is growing interest in complementary, non-invasive interventions that may enhance treatment effectiveness and improve neonatal outcomes.
Massage therapy and foot reflexology are commonly used complementary interventions in neonatal care. These interventions are thought to stimulate the gastrointestinal system, increase bowel movements, and facilitate bilirubin excretion. In addition, they may contribute to improved physiological stability and reduced stress levels through tactile stimulation.
This study is designed as a randomized controlled trial to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters, and stress levels in neonates receiving phototherapy. Physiological parameters include heart rate, respiratory rate, oxygen saturation, and body temperature.
The study will be conducted in a neonatal intensive care unit and will include 105 neonates diagnosed with indirect hyperbilirubinemia. Participants will be randomly assigned to one of three groups: foot reflexology group, body massage group, and control group. Interventions will be administered prior to phototherapy sessions.
Data will be collected using standardized tools, including a Neonatal Information Form, Neonatal Follow-up Form, and a validated Neonatal Stress Scale. Outcome measures will be assessed before and after the interventions.
The findings of this study are expected to provide evidence on the effectiveness of complementary non-pharmacological interventions in reducing bilirubin levels, improving physiological stability, and decreasing stress in neonates. These results may contribute to the integration of evidence-based complementary practices into neonatal care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups: foot reflexology group, body massage group, or control group. Each participant will remain in the assigned group throughout the study. The intervention groups will receive foot reflexology or body massage in addition to standard phototherapy care, while the control group will receive standard phototherapy care only.
| Arm | Type | Receives |
|---|---|---|
| Foot Reflexology Group | Experimental | Behavioral: Foot ReflexologyNeonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions. |
| Body Massage Group | Experimental | Behavioral: Body MassageNeonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions. |
| Control Group | Active comparator | Device: Phototherapy DeviceNeonates in this group will receive standard phototherapy care only without any additional intervention. |
Who may qualify
- Ages
- 2 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Neonates whose parents/legal guardians have signed the informed consent form and agreed to participate in the study
- Neonates born between 34 and 41 weeks of gestation
- Birth weight of 2500 g or above
- Not mechanically ventilated
- No nasogastric tube
Key exclusion criteria (7 listed)
- Presence of any neurological anomaly
- Presence of any congenital anomaly
- Jaundice due to ABO incompatibility
- Jaundice due to Rh incompatibility
- Presence of dermal anomalies
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 |
|---|---|---|
| Foot ReflexologyFoot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions. | Behavioural | Foot Reflexology Group |
| Body MassageBody massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions. | Behavioural | Body Massage Group |
| Phototherapy DevicePhototherapy will be provided using a standard phototherapy device according to the neonatal intensive care unit's routine clinical protocol for the management of neonatal indirect hyperbilirubinemia. | Device | Control Group |
Primary outcome
Total Serum Bilirubin Level
Time frame: Immediately before and immediately after each phototherapy session.
Total serum bilirubin level will be measured to evaluate the effect of foot reflexology and body massage on bilirubin reduction in neonates receiving phototherapy.
5 secondary outcomes
Heart rate
Time frame: Immediately before and immediately after each phototherapy session.
Respiratory Rate
Time frame: Immediately before and immediately after each phototherapy session.
Oxygen Saturation
Time frame: Immediately before and immediately after each phototherapy session.
Body Temperature
Time frame: Immediately before and immediately after each phototherapy session.
Neonatal Stress Level
Time frame: Immediately before and immediately after each phototherapy/intervention session.
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 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations involving neonatal participants. Aggregated study findings may be shared through scientific publications and presentations.
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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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.
ayten taspinar, Professor study chair
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Reflexology, Body Massage and Phototherapy Device in people with Neonatal Hyperbilirubinemia, run by Aydin Adnan Menderes 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 11 inclusion and 7 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 25 Sep 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 yagmur karadas, PhD (+905072209435, yagmurerisen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Serum Bilirubin Level (time frame: Immediately before and immediately after each phototherapy session.). 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 25 Sep 2026.