Massage for Newborns Receiving Nasal CPAP

NCT06360159 | Not Yet Recruiting DMC

• 1 other identifier: Massage on Newborns
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Massage; Stress; Newborn; Comfort

Keywords

massage; Stress; comfort; salivary cortisol level; nasal CPAP

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

• 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.

  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.

• 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.

  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.

• 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.

  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

• Nutrient ıntake amount

  Nutrient ıntake amount will be monitored on the daily nurse observation form.

  It will be monitored every day of the study for 3 days.

• Abdominal Circumference Measurement

  Abdominal circumference will be measured with the same tape measure immediately before and after each massage application during the research.

  Every day of the study for 3 days, abdominal circumference will be measured with the same tape measure.

• Defecation Frequency

  Defecation frequency will be monitored on the daily nurse observation form.

  It will be monitored every day of the study for 3 days.

Study Arms (2)

Intervention Group

EXPERIMENTAL

INTERVENTION GROUP: For newborn babies in the massage group; Field massage protocol will be used and the massage will be applied by the assistant researcher. Field massage developed by Field et al. (1986); In a standardized 15-minute stimulation session, the stimulation technique is changed every 5 minutes, and it is applied 3 times a day as tactile stimulation in the first 5 minutes, kinesthetic stimulation in the second 5 minutes and tactile stimulation in the third 5 minutes.(tactile stimulation-kinesthetic stimulation-tactile stimulation)

Other: Intervention

Control Group

NO INTERVENTION

CONTROL GROUP: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured.

Interventions

Intervention OTHER

As an intervention, the newborn will be massaged.

Intervention Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,
• Having no congenital anomaly,
• Not having any disease at birth such as neonatal asphyxia, hemolytic condition, patent ductus arteriosus (PDA),
• Those who have not undergone a surgical operation,
• The mother does not have alcohol, cigarette or other drug addiction,
• These are newborns to whom one of the parents (mother or father) has given verbal and written consent.

You may not qualify if:

• Rh and ABO incompatibility,
• APGAR score below 6,
• Analgesic or anesthetic medication is administered for sedation,
• Saliva sample cannot be taken,
• NEC developing,
• Leaving the hospital before the end of the working period,
• Having had maternal obstetric complications,
• Receiving blood transfusion during the study,
• Newborns whose parents wish to withdraw from the study will not be accepted.

Sponsors & Collaborators

• Sultan Besiktas: lead

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Meral Bayat

  TC Erciyes Universty

  STUDY DIRECTOR

Central Study Contacts

Sultan Beşiktaş

CONTACT

04462122222; besiktas0724@gmail.com

Meral Bayat

CONTACT

03522076666; bayatmeral@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher. Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: April 11, 2024
• Study Start: August 15, 2024
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share