- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06360159
Massage for Newborns Receiving Nasal CPAP
Effect of Massage on Stress, Comfort and Health Parameters of Newborns Receiving Nasal CPAP
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Purpose of the research
This research was planned to determine the effect of massage on stress (behavioral-newborn stress scale and biological-salivary cortisol level), comfort (Newborn Comfort Behavior Scale) and health parameters (bilirubin level, amount of food intake, abdominal distension and defecation frequency) of newborns receiving nasal CPAP. .
Research Type: This research is a randomized controlled experimental study.
Population and sample/Study group
The population of the research will consist of newborn babies admitted to the Neonatal Intensive Care Unit of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital. The research sample will consist of newborns who meet the research inclusion criteria. In the literature review, no study was found that evaluated the effect of massage on babies' stress (behavioral-newborn stress scale, biological-salivary cortisol level), comfort and health parameters (bilirubin level, food intake amount, abdominal distension and defecation frequency). Asmarani et al. (2020) in their study examining the effect of massage on salivary cortisol levels in premature newborns, it was determined that they reached 39 (19 intervention group, 20 control group) newborns (Asmarani et al., 2020). In this study, it was decided that the number of newborns in the groups would be 18, based on α = 95% confidence level and 80% power. The research sample will consist of 36 newborns (18 intervention group, 18 control group) who meet the research inclusion criteria.
Data collection tools
Newborn Information Form: Diagnosis of the newborn baby, gender, type of birth, height, birth weight, gestational and postnatal age, Apgar score, day of admission and discharge, time to start nasal CPAP application, total time of receiving nasal CPAP application, the status of receiving phototherapy treatment and the total number of hours of phototherapy treatment during the study will be recorded on this form.
Follow-up Form: The newborn baby's 3-day bilirubin level, defecation frequency, food intake amount, salivary cortisol level, abdominal circumference, stress and comfort scores will be recorded in this form during the study period.
Phototherapy Device: Okuman (Bilicare-BC 050 000) brand phototherapy device with blue LED technology will be used for phototherapy.
Digital Electronic Scale: NECK brand EBSH model baby scale (20 kg capacity - 5 g precision) will be used to measure the body weight of newborn babies.
Camera: A camera that can record, has high resolution, and has high optical focus will be used to evaluate the stress and comfort levels of babies in the intervention and control groups. The flash feature of the camera will not be used so that the baby is not disturbed by the camera light.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sultan Beşiktaş
- Phone Number: 04462122222
- Email: besiktas0724@gmail.com
Study Contact Backup
- Name: Meral Bayat
- Phone Number: 03522076666
- Email: bayatmeral@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
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)
|
As an intervention, the newborn will be massaged.
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress Level
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.
|
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
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.
|
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
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.
|
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
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
|
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
Time Frame: It will be monitored every day of the study for 3 days.
|
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
Time Frame: Every day of the study for 3 days, abdominal circumference will be measured with the same tape measure.
|
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
Time Frame: It will be monitored every day of the study for 3 days.
|
Defecation frequency will be monitored on the daily nurse observation form.
|
It will be monitored every day of the study for 3 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Meral Bayat, TC Erciyes Universty
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Massage on Newborns
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown
Clinical Trials on Intervention
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...American Cancer Society, Inc.Completed
-
Vanderbilt UniversityAgency for Healthcare Research and Quality (AHRQ)Completed