Health TrialsbyHealthPanel

Massage for Newborns Receiving Nasal CPAP

ConditionsMassageStressNewbornComfort
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorSultan Besiktas

About this trial

One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.

Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age greater than 34 weeks

Birth weight of 2000 g and above,

Within the first 24 hours of nasal CPAP application

Fed at least one hour before the procedure,

Disqualifiers

Rh and ABO incompatibility,

APGAR score below 6,

Analgesic or anesthetic medication is administered for sedation,

Saliva sample cannot be taken,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention

    Other intervention

    As an intervention, the newborn will be massaged.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Stress Level

Newborn Stress Scale: The newborn stress scale developed by Ceylan and Bolışık consists of a total of 24 items in a 3-point Likert type. The scale items include 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and each subgroup is evaluated between 0-2 points in scoring. The minimum score from the scale is zero and the maximum score is 16. As the score increases, the baby's stress level increases.

Time frame
Every day of the study for 3 days, the newborn's stress level will be evaluated 5 minutes before the first massage application and 5 minutes after the third massage application.
2

Salivary Cortisol Level

The newborn baby's saliva sample will be collected using the Salimetrics SalivaBio Infant's Swab (SIS). To collect a saliva sample, the swab will be held under the tongue and at the corners of the mouth for 60-90 seconds to obtain saliva and placed in the storage tube.

Time frame
The newborn baby's salivary cortisol sample will be taken between 05-09 in the morning on the 1st and 4th days of the study.
3

Comfort Score

Newborn Comfort Behavior Scale: The newborn comfort behavior scale, whose validity and reliability was established by Kahraman, Başbakkal and Yalaz (2014), is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. is the scale. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. It is emphasized that if the total score of the scale is between 9-13, the baby is comfortable, if it is between 14-30, the baby is in pain or distress, the baby is uncomfortable and needs interventions to provide comfort.

Time frame
Every day of the study for 3 days, the newborn's comfort level will be evaluated with the newborn comfort behavior scale 5 minutes before the first massage application and 5 minutes after the third massage application.
4

Bilirubin Level

Non-invasive bilirubin device: Non-invasive bilirubin device is a measuring device that measures babies' serum bilirubin non-invasively through the skin and has a measurement range of at least 0.0-20mg/dL. Bilirubin levels of newborns will be measured with this tool and recorded in the Monitoring Form.

Time frame
Every day of the study for 3 days, the newborn baby's bilirubin level will be measured twice a day (before the first massage application and after the third massage application) with a non-invasive bilirubin device

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sultan Besiktas

Lead sponsor

TC Erciyes University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: