Effect of ReflexologyNCT07549789
Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy
A study testing Foot reflexology in people with Effect of Reflexology and Hypoxic-Ischemic Encephalopathy, Neonatal, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Foot Reflexology
- What is being tested?
- Foot reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 27 Aug 2026
- Phase
- Interventional
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 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≥36 weeks
- Therapeutic hypothermia initiated within the first 6 hours after birth for hypoxic-ischemic encephalopathy
- Moderate or severe hypoxic-ischemic encephalopathy according to the modified Sarnat classification
- Evidence of perinatal hypoxia, including umbilical cord or early postnatal blood gas pH ≤7.00 or base excess ≤-16 mmol/L within the first hour of life, or a 10-minute Apgar score <5 or ongoing resuscitation
- Not receiving invasive mechanical ventilation
- Clinically stable for the intervention as determined by the attending neonatologist
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Invasive mechanical ventilation
- Major congenital anomaly
- Severe intracranial hemorrhage
- Multiple organ failure
- Skin lesion, trauma, or vascular access involving the lower extremities that could interfere with foot reflexology
- Active resuscitation
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- Severe hemodynamic instability
- Uncontrolled seizures or neurological deterioration compromising intervention safety
- Any clinical event or device/airway/vascular access concern preventing safe administration of the intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep Anka Hospital
Gaziantep, Gaziantep, 27590
About this study
Official title: Effect of Foot Reflexology on Comfort and Physiological Parameters in Neonates With Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia. Neonates in the intervention group will receive standardized foot reflexology sessions in addition to routine care, while the control group will receive routine care alone. Comfort will be assessed using the COMFORTneo scale, and physiological parameters will be monitored throughout the intervention period.
Read the detailed description
Hypoxic-ischemic encephalopathy (HIE) is a major cause of neonatal morbidity and mortality, and therapeutic hypothermia (TH) is the standard treatment to reduce neurological injury. However, during TH, the management of pain, distress, and comfort remains challenging, and evidence regarding optimal supportive care strategies is limited. Pharmacological approaches may have potential adverse effects, highlighting the need for safe and effective non-pharmacological interventions.
Foot reflexology is a complementary therapy based on the stimulation of specific points on the feet, which is thought to promote autonomic regulation, improve circulation, and enhance relaxation. In neonatal populations, existing studies on reflexology and similar tactile interventions have primarily focused on procedural pain and short-term outcomes. Evidence regarding sustained comfort and physiological regulation, particularly in critically ill neonates undergoing therapeutic hypothermia, remains scarce.
This study is designed as a randomized controlled trial to evaluate the effect of foot reflexology on comfort and physiological parameters in neonates with HIE undergoing TH. Participants will be randomly assigned to either an intervention group receiving foot reflexology in addition to routine care or a control group receiving routine care alone.
The reflexology intervention will be applied in a standardized manner during the hypothermia period by a trained practitioner. The protocol is structured to ensure consistency, safety, and compatibility with intensive care conditions.
Comfort will be assessed using the COMFORTneo scale, a validated and reliable tool for evaluating prolonged pain and distress in neonates. In addition, physiological parameters including heart rate, respiratory rate, oxygen saturation, mean arterial pressure, and body temperature will be monitored to assess physiological stability.
The primary objective of this study is to determine whether foot reflexology improves comfort levels in neonates undergoing TH. Secondary objectives include evaluating its effects on physiological parameters and assessing the safety of the intervention in this vulnerable population.
The findings of this study are expected to contribute to the evidence base for non-pharmacological supportive care in neonatal intensive care units and may support the integration of reflexology into clinical practice if proven effective and safe.
- Conditions
- Effect of Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Foot Reflexology, Therapeutic Hypothermia
- Being tested
- Foot reflexology, Standard care
- Keywords
- Foot reflexology, therapeutic hypothermia, Hypoxic-Ischemic Encephalopathy, ComfortNeo
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexologyOther
A standardized foot reflexology protocol was administered three times daily at approximately 8-hour intervals for 72 hours. Each session lasted 15 minutes, with equal time allocated to both feet, resulting in nine sessions and a cumulative intervention time of 135 minutes per participant. The intervention targeted four protocol-defined foot areas: the head/brain, solar plexus, spine, and diaphragm zones. Light-to-moderate pressure was applied, while abrupt, forceful, or painful pressure was avoided. No oil, lotion, or warming material was used. All sessions were performed by the same trained and certified researcher under continuous clinical monitoring and predefined safety stopping criteria.
Standard careOther
Standard therapeutic hypothermia and routine neonatal intensive care without additional tactile stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Foot Reflexology | Experimental | Participants in this arm received standardized foot reflexology in addition to standard care during therapeutic hypothermia. Foot reflexology was administered three times daily at approximately 8-hour intervals for 72 hours. Each session lasted 15 minutes, with equal time allocated to both feet, resulting in a total of nine sessions and a cumulative intervention time of 135 minutes per participant. All sessions were performed by the same trained and certified researcher under continuous clinical monitoring and predefined safety stopping criteria. Receives: Other: Foot reflexology |
| Standard Care | Active comparator | Participants in this arm received standard therapeutic hypothermia and routine neonatal intensive care without any additional tactile intervention or foot reflexology. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMFORTneo score
COMFORTneo was used to assess pain and distress in neonates. The scale consists of six behavioral items scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate greater pain or distress. COMFORTneo assessments were performed at baseline (T0), 24 hours (T1), 48 hours (T2), and 72 hours (T3) by an outcome assessor blinded to group allocation.
Measured: Baseline, 24 hours, 48 hours, and 72 hours
Secondary outcomes (5)
Heart rate
Heart rate (beats/min) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.
Measured: Immediately before and immediately after one designated session per day for 3 consecutive days
Respiratory rate
Respiratory rate (breaths/min) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.
Measured: Immediately before and immediately after one designated session per day for 3 consecutive days
Rectal temperature
Rectal temperature (°C) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.
Measured: Immediately before and immediately after one designated session per day for 3 consecutive days
Mean arterial pressure (MAP)
Mean arterial pressure (MAP, mmHg) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.
Measured: Immediately before and immediately after one designated session per day for 3 consecutive days
Oxygen saturation (SpO₂)
Peripheral oxygen saturation (SpO₂, %) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.
Measured: Immediately before and immediately after one designated session per day for 3 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start3 Feb 2025
- Primary completion27 Aug 2026
- Study completion27 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of ReflexologyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention group or the control group using a parallel-group design with a 1:1 allocation ratio. The intervention group will receive standardized foot reflexology in addition to routine neonatal intensive care, while the control group will receive routine care only. The study follows a parallel assignment model in which both groups are observed over the same therapeutic hypothermia period. The intervention is administered repeatedly to evaluate both immediate and cumulative effects on comfort and physiological parameters. Outcome measures are collected at predefined time points across the study period to allow comparison between groups and over time. Blinding will be applied at the level of outcome assessment to minimize bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Sivasli, Istanbul Nisantasi University
- Investigators
- Alev S Sivaslı, PhD, Principal investigator, istanbul nişantaşı üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549789
- Sponsor's protocol ID
- 06.02.2025/SBETKK2025-02
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Sep 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 made publicly available because the study involves sensitive neonatal clinical data and is subject to ethical and privacy restrictions. De-identified data may be made available from the corresponding author upon reasonable request, subject to applicable ethical approval, institutional requirements, and data protection regulations.