Foot Reflexology and Massage in Neonates Receiving Phototherapy
ConditionNeonatal Hyperbilirubinemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-10
SponsorAydin Adnan Menderes University
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Presence of any neurological anomaly
Presence of any congenital anomaly
Jaundice due to ABO incompatibility
Jaundice due to Rh incompatibility
Trial design
Design model
Parallel
Treatments tested in this trial
Foot Reflexology
BehavioralFoot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Body Massage
BehavioralBody massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Phototherapy Device
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.
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Foot Reflexology GroupExperimental treatment 1 intervention
Group B: Body Massage GroupExperimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately before and immediately after each phototherapy session.Secondary outcomes
1
Heart rate
Heart rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as beats per minute.
Time frame
Immediately before and immediately after each phototherapy session.2
Respiratory Rate
Respiratory rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as breaths per minute.
Time frame
Immediately before and immediately after each phototherapy session.3
Oxygen Saturation
Oxygen saturation will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as percentage oxygen saturation.
Time frame
Immediately before and immediately after each phototherapy session.4
Body Temperature
Body temperature will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported in degrees Celsius.
Time frame
Immediately before and immediately after each phototherapy session.Sponsors and contacts
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Source ClinicalTrials.gov