Clinical trial NCT06360159: Massage for Newborns Receiving Nasal CPAP
Official title: Effect of Massage on Stress, Comfort and Health Parameters of Newborns Receiving Nasal CPAP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Massage
Stress
Newborn
Comfort
Keywords: massage
Stress
comfort
salivary cortisol level
nasal CPAP
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Gestational age greater than 34 weeks
2. Birth weight of 2000 g and above,
3. Within the first 24 hours of nasal CPAP application
4. Fed at least one hour before the procedure,
5. Having no congenital anomaly,
6. Not having any disease at birth such as neonatal asphyxia, hemolytic condition, patent ductus arteriosus (PDA),
7. Those who have not undergone a surgical operation,
8. The mother does not have alcohol, cigarette or other drug addiction,
9. These are newborns to whom one of the parents (mother or father) has given verbal and written consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Stress Level
timeFrame: 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.
measure: Salivary Cortisol Level
timeFrame: 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.
measure: Comfort Score
timeFrame: 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.
measure: Bilirubin Level
timeFrame: 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
measure: Nutrient ıntake amount
timeFrame: It will be monitored every day of the study for 3 days.
measure: Abdominal Circumference Measurement
timeFrame: Every day of the study for 3 days, abdominal circumference will be measured with the same tape measure.
measure: Defecation Frequency
timeFrame: It will be monitored every day of the study for 3 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes Universty
name: Meral Bayat
role: STUDY_DIRECTOR
References: