Premature NewbornNCT04602130
The Effect of Massage, Wipe Bathing and Tub Bathing on Physiological Measurements of Late Premature Newborns
A study testing Massage, Sponge Bathing and Tub Bathing in people with Premature Newborn and Nurse, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements. Design and Methods: . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Newborn, Nurse, Physiological Measurements
- What is being tested?
- Massage, Sponge Bathing and Tub Bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- newborns who born at 34 weeks' gestation and over
- newborns who receiving routine care and who were stable (temperature >36.5 °C, SpO2> 95%, HR = 120-160 / min)
- newborns who had an apgar score of 7 or higher at the first minute after birth;
- newborns who at least 24 hours old
Who cannot join
- newborns with any health problems that prevent bathing (eg congenital anomaly, surgical intervention, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage, Wipe Bathing and Tub Bathing on Physiological Measurements of Late Premature Newborns: A Randomised Controlled Trial
Purpose: This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.
Design and Methods: . This randomized experimental study was conducted on 192 newborns at the gestational week of 34 or higher in the newborn intensive care unit of a university hospital. The researcher applied massage (n: 48), tub bathing (n: 48), and wipe bathing (n: 48) to the newborns. The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." The statistical analysis was performed using percentages, means, and ANOVA test.
Read the detailed description
The neonatal period covers the postnatal first 28 days. During this period, newborns try to adapt to the extrauterine life after the intrauterine life and stabilize their respiratory and circulatory functions. Therefore, the acquisition of information on newborns' vital signs is crucial in the evaluation of and caregiving for newborns. The increase in evidence-based studies in nursing has led to changes and developments in the caregiving instructions that have hitherto been used in newborn intensive care units. However, the required and effective nursing practices that are considered indispensable in newborn intensive care units may cause various physiological (increase or decrease in heart and respiration rate, temporary decrease in oxygen saturation, hypothermia) and behavioral reactions (crying, uneasiness) Nurses, therefore, should closely monitor newborns' vital signs and make various interventions to keep these signs within normal values, as a primary practice.
The literature includes many studies conducted by nurses that focus on keeping newborns' physiological measurements within normal values. Massage means the stimulation of the soft tissues in the body. Previous studies have indicated that massage has positive effects such as relaxing the muscles, relieving pain, reducing bilirubin values by enabling blood and lymphatic circulation, increasing sleep duration, and strengthening the relationship between mothers and newborns. However, only a limited number of studies exist on the effects of massage on newborns' physiological measurements reported that the tactile stimulus through massages supported premature infants' parasympathetic functions and positively affected the infants' heart rate by reducing neurochemical and stress stimuli. Furthermore, Dieogo et al. (2008) reported that premature infants' body temperature increased due to the increased blood circulation during massage.
The bathing of newborns plays a highly important role in routine newborn clinical care practices, as well as in the individual, aesthetic, cultural, and hygienic benefits it confers. In neonatal intensive care units (NICU), tub baths, wipe baths, swaddle baths and shower-type bathing are commonly used. In Turkey, however, wipe baths and tub baths are often the most commonly used bathing methods in neonatal intensive care units . Although the literature shows differences among the institutions and countries, in newborn care units, wipe bathing is generally carried out by nurses, and tub bathing is not recommended until the infants' naval cord falls of. Numerous studies have shown that bathing can be performed without harming the newborn. Bryanton et al. (2004) indicated in their study that thermoregulation was ensured for the infants by drying them under a radiant warmer and placing them in an incubator. Mörelus et al. (2006) reported that infants might show physiological reactions, such as increased respiration and heart rate, to any stress. They also found that bathing positively affected infants' physiological measurements by relaxing them and reducing their stress levels. Studies that compare the effects of traditional wipe and tub bathing on newborns' physiological measurements have shown that tub bathing had more positive effects than wipe bathing. However, no studies have analyzed in the related literature that investigate the effects of massage, wipe bathing and tub bathing on physiological measurements, in the studies also have several inconsistencies, such as a small sample size, the failure to use control groups and a lack of blinding and follow-up. This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.
Study design, setting, and population This study was conducted as a randomised controlled study between January and December 2018 in the NICU of a university hospital in Turkey. The NICU employs 30 nurses who provide newborns with bathing care performed routinely between 2 and 3 pm each afternoon.
In this study, permission to conduct the research was obtained from the hospital and the Inonu University Health Sciences Scientific Research and Publication Ethics Committee. All parents who agreed to participate in the research were informed of its methods and purpose, and each completed an informed consent form.
The study sample included the newborns who a) were born at 34 weeks' gestation and over b) were receiving routine care and who were stable (temperature >36.5 °C, SpO2> 95%, HR = 120-160 / min) c) had an apgar score of 7 or higher at the first minute after birth; d) were at least 24 hours old and who had no health problems that prevent bathing (e.g., congenital anomaly, surgical intervention, etc.) were included in the research.
The G*Power software package was used to calculate the sample size. The sample consisted of 192 newborns who comprised (d=0.5)effect size and(α=0.050) alpha level and95%confidence level(1-β) according to the power analysis. Each group consisted of 48 patients.
Randomizasyon Newborns meeting the inclusion criteria were randomly allocated to one of the 4 groups. Numbers were given to newborns sequentially on entry into the study and the random number stable used to allocate to one of 4 groups.
Physiological measurements Oxygen saturation Heart rate and oxygen saturations of newborns were examined using a pulse oximeter. A separate pulse oximetry probe was used for each baby.
Body temperature Newborns' body temperatures were measured using a non-contact thermometer. Bath water temperature The temperature of the water used for bathing was controlled using a bath thermometer.
Data Collection Tools The data were collected using the "Newborn Follow-up Form."
Newborn Follow-up Form:
This form was prepared by the researcher upon a literature review and included questions on the newborns' height, weight, diagnosis, gender, gestational age, physiological measurements (pulse, respiration, oxygen saturation, blood pressure, body temperature), and the delivery method.
PROCEDURE Preparation for applications The newborns' mothers were allowed to observe during the applications (massage, wipe bath and tub bath use). Suitable environmental conditions were provided for all newborns. The massages and wipe bathing were performed first by setting an appropriate temperature and humidity in the tub bathing . The door of the room used for bathing was kept closed, preventing heat loss and convection caused by air circulation. The room temperature and humidity were set to 26-28 °C and 40-60%, respectively. The duration of the applications was a maximum of 5 minutes. Clinical care of newborns (at least half an hour after feeding) and treatment processes were taken into consideration. In addition, the newborns were not touched until the evaluation was completed after the massage and bath.
For the massage application, alcohol-free and paraben-free baby oil with moisturising properties, suitable for newborns' skin type, was used. The temperature of the water used for the sponge bath was set at 37-38 °C, and separate cotton wipes were used for each body region. A folded cloth towel was placed in the tub bath before the bathing began. The water level inside the tub was set to 9-12 cm, deep enough to cover the newborn's shoulders. The temperature of the bath water was controlled using a special water thermometer.
The materials used during the applications were placed in easily accessible places, and nurses wore gloves after washing their hands prior to beginning the activities. All materials were disinfected after each application. The researchers were not involved in clinical follow-up of the infants, and nurses took all physiological measurements, recording them on the Newborn Follow-up Form.
Interventions Control Group The newborns in the control group did not undergo any intervention other than standard clinical practices. All physiological measurements (pulse, respiration, oxygen saturation and body temperature) were performed by nurses and recorded on the Newborn Follow-up Form.
Massage Group Massages were performed starting from the face, focused on the newborns forehead, and then around the eyes and cheeks with gentle touches. Then, newborns' chest area and the upper and lower extremities were massaged. Finally, newborns'were placed prone position and the back was massaged. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Wipe Bathing Group In the sponge bathing group, the newborns' eyes, faces (outward from the midline), around the ear and the back of the ear were wiped from the inside out with cotton wipes and dried. Then, the chest area and arms, abdomen and back, legs and feet, respectively, were wiped and dried. Finally, the genital area was cleaned, before diapering the newborn. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Tub Bathing Group In the tub bathing group, before being immersed in the tub, the newborns' faces and heads were cleaned outwards from the midline and dried. Then, the neck, chest, arms, back, legs and genital area were soaped, before the full body was rinsed and dried. Finally, umbilical cord care was performed, and the baby was diapered. Nurses recorded the newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
- Conditions
- Premature Newborn, Nurse, Physiological Measurements
- Being tested
- Control, Massage, Sponge Bathing, Tub Bathing
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called Control Group
The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
MassageOther
Also called Massage Group
The researcher applied massage (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
Sponge BathingOther
Also called Sponge Bathing Group
The researcher applied sponge bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
Tub BathingOther
Also called Tub Bathing Group
The researcher applied tub bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form."
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Massages were performed starting from the face, focused on the newborns forehead, and then around the eyes and cheeks with gentle touches. Then, newborns' chest area and the upper and lower extremities were massaged. Finally, newborns'were placed prone position and the back was massaged. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form. Receives: Other: Control; Other: Sponge Bathing; Other: Tub Bathing |
| Sponge Bathing | Experimental | In the sponge bathing group, the newborns' eyes, faces (outward from the midline), around the ear and the back of the ear were wiped from the inside out with cotton wipes and dried. Then, the chest area and arms, abdomen and back, legs and feet, respectively, were wiped and dried. Finally, the genital area was cleaned, before diapering the newborn. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form Receives: Other: Control; Other: Massage; Other: Tub Bathing |
| Tub bathing | Experimental | In the tub bathing group, before being immersed in the tub, the newborns' faces and heads were cleaned outwards from the midline and dried. Then, the neck, chest, arms, back, legs and genital area were soaped, before the full body was rinsed and dried. Finally, umbilical cord care was performed, and the baby was diapered. Nurses recorded the newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form. Receives: Other: Control; Other: Massage; Other: Sponge Bathing |
| Control | No intervention | The newborns in the control group did not undergo any intervention other than standard clinical practices. All physiological measurements (pulse, respiration, oxygen saturation and body temperature) were performed by nurses and recorded on the Newborn Follow-up Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulse
Nurses recorded the changes in pulse(HR) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
Measured: 30 minutes
Secondary outcomes (3)
Changes in respiration
Nurses recorded the changes in respiration (O2) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
Measured: 30 minutes
:Changes in oxygen saturation
Nurses recorded the changes in oxygen saturation (SpO2) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
Measured: 30 minutes
Changes in body temperature
Nurses recorded the changes in body temperature (°C) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Jan 2018
- Primary completion18 Nov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz SUNA DAĞ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602130
- Sponsor's protocol ID
- Yaşam bulgusu
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
PubMed 22375955Ala, H., Thaer, M., & Dina, S. (2010). The Effect of Timing of Initial Bath on Newborn's Temperature. Middle East Journal of Nursing, 4(3), 16-19.
Ar I, Gozen D. Effects of Underrunning Water Bathing and Immersion Tub Bathing on Vital Signs of Newborn Infants: A Comparative Analysis. Adv Neonatal Care. 2018 Dec;18(6):E3-E12. doi: 10.1097/ANC.0000000000000484.
PubMed 30507829Association of Women's Health Obstetric and Neonatal Nurses, & (AWHONN). (2013). Neonatal skin care: Evidence-based clinical practice guideline. Washington: AWHONN
Blume-Peytavi U, Lavender T, Jenerowicz D, Ryumina I, Stalder JF, Torrelo A, Cork MJ. Recommendations from a European Roundtable Meeting on Best Practice Healthy Infant Skin Care. Pediatr Dermatol. 2016 May;33(3):311-21. doi: 10.1111/pde.12819. Epub 2016 Feb 26.
PubMed 26919683Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
PubMed 15561658Conk, Z., Başbakkal, Z., Bal Yılmaz, H., & Bolışık, B. (Eds.). (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Akademisye). Ankara.
Caka SY, Gozen D. Effects of swaddled and traditional tub bathing methods on crying and physiological responses of newborns. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12202. Epub 2017 Nov 21.
PubMed 29160925Çavuşoğlu, H. (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Sistem Ofs). Ankara.
Darmstadt GL, Dinulos JG. Neonatal skin care. Pediatr Clin North Am. 2000 Aug;47(4):757-82. doi: 10.1016/s0031-3955(05)70239-x.
PubMed 10943256Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
PubMed 16027695Diego MA, Field T, Hernandez-Reif M. Temperature increases in preterm infants during massage therapy. Infant Behav Dev. 2008 Jan;31(1):149-52. doi: 10.1016/j.infbeh.2007.07.002. Epub 2007 Aug 9.
PubMed 17692385Jain S, Kumar P, McMillan DD. Prior leg massage decreases pain responses to heel stick in preterm babies. J Paediatr Child Health. 2006 Sep;42(9):505-8. doi: 10.1111/j.1440-1754.2006.00912.x.
PubMed 16925535Kurtulan Bulut, H. (2009). Prematüre Bebeklerde İki Banyo Yönteminin Fizyolojik Ölçüm Sonuçlarına Etkisi. Dokuz Eylül Üniversitesi.
Lee HK. Effects of sponge bathing on vagal tone and behavioural responses in premature infants. J Clin Nurs. 2002 Jul;11(4):510-9. doi: 10.1046/j.1365-2702.2002.00594.x.
PubMed 12100647
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage, Wipe Bathing and Tub Bathing on Physiological Measurements of Late Premature Newborns: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04602130
- Acronym / sponsor ID
- Yaşam bulgusu
- Conditions
- Premature Newborn, Nurse, Physiological Measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 18 Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.
Design and Methods: . This randomized experimental study was conducted on 192 newborns at the gestational week of 34 or higher in the newborn intensive care unit of a university hospital. The researcher applied massage (n: 48), tub bathing (n: 48), and wipe bathing (n: 48) to the newborns. The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." The statistical analysis was performed using percentages, means, and ANOVA test.
Detailed description
The neonatal period covers the postnatal first 28 days. During this period, newborns try to adapt to the extrauterine life after the intrauterine life and stabilize their respiratory and circulatory functions. Therefore, the acquisition of information on newborns' vital signs is crucial in the evaluation of and caregiving for newborns. The increase in evidence-based studies in nursing has led to changes and developments in the caregiving instructions that have hitherto been used in newborn intensive care units. However, the required and effective nursing practices that are considered indispensable in newborn intensive care units may cause various physiological (increase or decrease in heart and respiration rate, temporary decrease in oxygen saturation, hypothermia) and behavioral reactions (crying, uneasiness) Nurses, therefore, should closely monitor newborns' vital signs and make various interventions to keep these signs within normal values, as a primary practice.
The literature includes many studies conducted by nurses that focus on keeping newborns' physiological measurements within normal values. Massage means the stimulation of the soft tissues in the body. Previous studies have indicated that massage has positive effects such as relaxing the muscles, relieving pain, reducing bilirubin values by enabling blood and lymphatic circulation, increasing sleep duration, and strengthening the relationship between mothers and newborns. However, only a limited number of studies exist on the effects of massage on newborns' physiological measurements reported that the tactile stimulus through massages supported premature infants' parasympathetic functions and positively affected the infants' heart rate by reducing neurochemical and stress stimuli. Furthermore, Dieogo et al. (2008) reported that premature infants' body temperature increased due to the increased blood circulation during massage.
The bathing of newborns plays a highly important role in routine newborn clinical care practices, as well as in the individual, aesthetic, cultural, and hygienic benefits it confers. In neonatal intensive care units (NICU), tub baths, wipe baths, swaddle baths and shower-type bathing are commonly used. In Turkey, however, wipe baths and tub baths are often the most commonly used bathing methods in neonatal intensive care units . Although the literature shows differences among the institutions and countries, in newborn care units, wipe bathing is generally carried out by nurses, and tub bathing is not recommended until the infants' naval cord falls of. Numerous studies have shown that bathing can be performed without harming the newborn. Bryanton et al. (2004) indicated in their study that thermoregulation was ensured for the infants by drying them under a radiant warmer and placing them in an incubator. Mörelus et al. (2006) reported that infants might show physiological reactions, such as increased respiration and heart rate, to any stress. They also found that bathing positively affected infants' physiological measurements by relaxing them and reducing their stress levels. Studies that compare the effects of traditional wipe and tub bathing on newborns' physiological measurements have shown that tub bathing had more positive effects than wipe bathing. However, no studies have analyzed in the related literature that investigate the effects of massage, wipe bathing and tub bathing on physiological measurements, in the studies also have several inconsistencies, such as a small sample size, the failure to use control groups and a lack of blinding and follow-up. This randomized experimental study aimed to analyze the effect of massage, wipe bathing and tub bathing of late premature newborns on their physiological measurements.
Study design, setting, and population This study was conducted as a randomised controlled study between January and December 2018 in the NICU of a university hospital in Turkey. The NICU employs 30 nurses who provide newborns with bathing care performed routinely between 2 and 3 pm each afternoon.
In this study, permission to conduct the research was obtained from the hospital and the Inonu University Health Sciences Scientific Research and Publication Ethics Committee. All parents who agreed to participate in the research were informed of its methods and purpose, and each completed an informed consent form.
The study sample included the newborns who a) were born at 34 weeks' gestation and over b) were receiving routine care and who were stable (temperature >36.5 °C, SpO2> 95%, HR = 120-160 / min) c) had an apgar score of 7 or higher at the first minute after birth; d) were at least 24 hours old and who had no health problems that prevent bathing (e.g., congenital anomaly, surgical intervention, etc.) were included in the research.
The G*Power software package was used to calculate the sample size. The sample consisted of 192 newborns who comprised (d=0.5)effect size and(α=0.050) alpha level and95%confidence level(1-β) according to the power analysis. Each group consisted of 48 patients.
Randomizasyon Newborns meeting the inclusion criteria were randomly allocated to one of the 4 groups. Numbers were given to newborns sequentially on entry into the study and the random number stable used to allocate to one of 4 groups.
Physiological measurements Oxygen saturation Heart rate and oxygen saturations of newborns were examined using a pulse oximeter. A separate pulse oximetry probe was used for each baby.
Body temperature Newborns' body temperatures were measured using a non-contact thermometer. Bath water temperature The temperature of the water used for bathing was controlled using a bath thermometer.
Data Collection Tools The data were collected using the "Newborn Follow-up Form."
Newborn Follow-up Form:
This form was prepared by the researcher upon a literature review and included questions on the newborns' height, weight, diagnosis, gender, gestational age, physiological measurements (pulse, respiration, oxygen saturation, blood pressure, body temperature), and the delivery method.
PROCEDURE Preparation for applications The newborns' mothers were allowed to observe during the applications (massage, wipe bath and tub bath use). Suitable environmental conditions were provided for all newborns. The massages and wipe bathing were performed first by setting an appropriate temperature and humidity in the tub bathing . The door of the room used for bathing was kept closed, preventing heat loss and convection caused by air circulation. The room temperature and humidity were set to 26-28 °C and 40-60%, respectively. The duration of the applications was a maximum of 5 minutes. Clinical care of newborns (at least half an hour after feeding) and treatment processes were taken into consideration. In addition, the newborns were not touched until the evaluation was completed after the massage and bath.
For the massage application, alcohol-free and paraben-free baby oil with moisturising properties, suitable for newborns' skin type, was used. The temperature of the water used for the sponge bath was set at 37-38 °C, and separate cotton wipes were used for each body region. A folded cloth towel was placed in the tub bath before the bathing began. The water level inside the tub was set to 9-12 cm, deep enough to cover the newborn's shoulders. The temperature of the bath water was controlled using a special water thermometer.
The materials used during the applications were placed in easily accessible places, and nurses wore gloves after washing their hands prior to beginning the activities. All materials were disinfected after each application. The researchers were not involved in clinical follow-up of the infants, and nurses took all physiological measurements, recording them on the Newborn Follow-up Form.
Interventions Control Group The newborns in the control group did not undergo any intervention other than standard clinical practices. All physiological measurements (pulse, respiration, oxygen saturation and body temperature) were performed by nurses and recorded on the Newborn Follow-up Form.
Massage Group Massages were performed starting from the face, focused on the newborns forehead, and then around the eyes and cheeks with gentle touches. Then, newborns' chest area and the upper and lower extremities were massaged. Finally, newborns'were placed prone position and the back was massaged. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Wipe Bathing Group In the sponge bathing group, the newborns' eyes, faces (outward from the midline), around the ear and the back of the ear were wiped from the inside out with cotton wipes and dried. Then, the chest area and arms, abdomen and back, legs and feet, respectively, were wiped and dried. Finally, the genital area was cleaned, before diapering the newborn. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Tub Bathing Group In the tub bathing group, before being immersed in the tub, the newborns' faces and heads were cleaned outwards from the midline and dried. Then, the neck, chest, arms, back, legs and genital area were soaped, before the full body was rinsed and dried. Finally, umbilical cord care was performed, and the baby was diapered. Nurses recorded the newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Control, Other: Sponge Bathing, Other: Tub BathingMassages were performed starting from the face, focused on the newborns forehead, and then around the eyes and cheeks with gentle touches. Then, newborns' chest area and the upper and lower extremities were massaged. Finally, newborns'were placed prone position and the back was massaged. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form. |
| Sponge Bathing | Experimental | Other: Control, Other: Massage, Other: Tub BathingIn the sponge bathing group, the newborns' eyes, faces (outward from the midline), around the ear and the back of the ear were wiped from the inside out with cotton wipes and dried. Then, the chest area and arms, abdomen and back, legs and feet, respectively, were wiped and dried. Finally, the genital area was cleaned, before diapering the newborn. Nurses recorded newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form |
| Tub bathing | Experimental | Other: Control, Other: Massage, Other: Sponge BathingIn the tub bathing group, before being immersed in the tub, the newborns' faces and heads were cleaned outwards from the midline and dried. Then, the neck, chest, arms, back, legs and genital area were soaped, before the full body was rinsed and dried. Finally, umbilical cord care was performed, and the baby was diapered. Nurses recorded the newborns' physiological measurements (pulse, respiration, oxygen saturation and body temperature) on the Newborn Follow-up Form. |
| Control | No intervention | –The newborns in the control group did not undergo any intervention other than standard clinical practices. All physiological measurements (pulse, respiration, oxygen saturation and body temperature) were performed by nurses and recorded on the Newborn Follow-up Form. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- newborns who born at 34 weeks' gestation and over
- newborns who receiving routine care and who were stable (temperature >36.5 °C, SpO2> 95%, HR = 120-160 / min)
- newborns who had an apgar score of 7 or higher at the first minute after birth;
- newborns who at least 24 hours old
Key exclusion criteria (1 listed)
- newborns with any health problems that prevent bathing (eg congenital anomaly, surgical intervention, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: Control GroupThe control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." | Other | Massage, Sponge Bathing, Tub bathing |
| MassageAlso: Massage GroupThe researcher applied massage (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." | Other | Sponge Bathing, Tub bathing |
| Sponge BathingAlso: Sponge Bathing GroupThe researcher applied sponge bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." | Other | Massage, Tub bathing |
| Tub BathingAlso: Tub Bathing GroupThe researcher applied tub bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the "Newborn Follow-up Form." | Other | Massage, Sponge Bathing |
Primary outcome
Changes in pulse
Time frame: 30 minutes
Nurses recorded the changes in pulse(HR) of newborns before, immediately after and 30 minutes after the intervention on the Newborn Follow up Survey.
3 secondary outcomes
Changes in respiration
Time frame: 30 minutes
:Changes in oxygen saturation
Time frame: 30 minutes
Changes in body temperature
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Background: PubMed 22375955Loring C, Gregory K, Gargan B, LeBlanc V, Lundgren D, Reilly J, Stobo K, Walker C, Zaya C. Tub bathing improves thermoregulation of the late preterm infant. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):171-179. doi: 10.1111/j.1552-6909.2011.01332.x. Epub 2012 Feb 29.
- Results publicationAla, H., Thaer, M., & Dina, S. (2010). The Effect of Timing of Initial Bath on Newborn's Temperature. Middle East Journal of Nursing, 4(3), 16-19.
- Results publication: PubMed 30507829Ar I, Gozen D. Effects of Underrunning Water Bathing and Immersion Tub Bathing on Vital Signs of Newborn Infants: A Comparative Analysis. Adv Neonatal Care. 2018 Dec;18(6):E3-E12. doi: 10.1097/ANC.0000000000000484.
- Results publicationAssociation of Women's Health Obstetric and Neonatal Nurses, & (AWHONN). (2013). Neonatal skin care: Evidence-based clinical practice guideline. Washington: AWHONN
- Results publication: PubMed 26919683Blume-Peytavi U, Lavender T, Jenerowicz D, Ryumina I, Stalder JF, Torrelo A, Cork MJ. Recommendations from a European Roundtable Meeting on Best Practice Healthy Infant Skin Care. Pediatr Dermatol. 2016 May;33(3):311-21. doi: 10.1111/pde.12819. Epub 2016 Feb 26.
- Results publication: PubMed 15561658Bryanton J, Walsh D, Barrett M, Gaudet D. Tub bathing versus traditional sponge bathing for the newborn. J Obstet Gynecol Neonatal Nurs. 2004 Nov-Dec;33(6):704-12. doi: 10.1177/0884217504270651.
- Results publicationConk, Z., Başbakkal, Z., Bal Yılmaz, H., & Bolışık, B. (Eds.). (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Akademisye). Ankara.
- Results publication: PubMed 29160925Caka SY, Gozen D. Effects of swaddled and traditional tub bathing methods on crying and physiological responses of newborns. J Spec Pediatr Nurs. 2018 Jan;23(1). doi: 10.1111/jspn.12202. Epub 2017 Nov 21.
- Results publicationÇavuşoğlu, H. (2013). Çocuk Sağlığı ve Hastalıkları Hemşireliği (Sistem Ofs). Ankara.
- Results publication: PubMed 10943256Darmstadt GL, Dinulos JG. Neonatal skin care. Pediatr Clin North Am. 2000 Aug;47(4):757-82. doi: 10.1016/s0031-3955(05)70239-x.
- Results publication: PubMed 16027695Diego MA, Field T, Hernandez-Reif M. Vagal activity, gastric motility, and weight gain in massaged preterm neonates. J Pediatr. 2005 Jul;147(1):50-5. doi: 10.1016/j.jpeds.2005.02.023.
- Results publication: PubMed 17692385Diego MA, Field T, Hernandez-Reif M. Temperature increases in preterm infants during massage therapy. Infant Behav Dev. 2008 Jan;31(1):149-52. doi: 10.1016/j.infbeh.2007.07.002. Epub 2007 Aug 9.
Related trials for Premature Newborn
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage, Sponge Bathing and Tub Bathing in people with Premature Newborn and Nurse, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulse (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602130, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.