Preterm Birth Clinical Trial
Official title:
The Effect of Rocking Bed on Comfort, Physiological Parameters and Cerebral Oxygenation Level of Preterm Infants: a Near Infrared Spectroscopy Study
Verified date | July 2023 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rSO2).
Status | Completed |
Enrollment | 36 |
Est. completion date | September 15, 2022 |
Est. primary completion date | September 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 32 Weeks to 37 Weeks |
Eligibility | Inclusion Criteria: - Born at 32-37 weeks of postmenstruel age - Not receiving mechanical ventilation support, - Not receiving analgesia or sedative drug therapy, - Congenital anomaly, intraventricular hemorrhage, meningitis, chromosomal anomalies, cyanotic congenital heart diseases, neonatal seizures and preterm infants without a diagnosis of sepsis Exclusion Criteria: • Infants with diseases that may decrease cerebral oxygenation such as cerebral edema, intraventricular hemorrhage, cerebral hypoxia will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University | Konya | Selcuklu |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
Ambuel B, Hamlett KW, Marx CM, Blumer JL. Assessing distress in pediatric intensive care environments: the COMFORT scale. J Pediatr Psychol. 1992 Feb;17(1):95-109. doi: 10.1093/jpepsy/17.1.95. — View Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239. — View Citation
O'Reilly R, Grindle C, Zwicky EF, Morlet T. Development of the vestibular system and balance function: differential diagnosis in the pediatric population. Otolaryngol Clin North Am. 2011 Apr;44(2):251-71, vii. doi: 10.1016/j.otc.2011.01.001. — View Citation
Provasi J, Blanc L, Carchon I. The Importance of Rhythmic Stimulation for Preterm Infants in the NICU. Children (Basel). 2021 Jul 29;8(8):660. doi: 10.3390/children8080660. — View Citation
van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a. — View Citation
Zimmerman E, Barlow SM. The effects of vestibular stimulation rate and magnitude of acceleration on central pattern generation for chest wall kinematics in preterm infants. J Perinatol. 2012 Aug;32(8):614-20. doi: 10.1038/jp.2011.177. Epub 2011 Dec 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Information Form | In the form prepared by the researchers in line with the literature in order to collect introductory information about the baby; There are questions for the baby such as gender, mode of delivery, weight at birth, Apgar score (1st and 5th value), gestational age at birth, postnatal age, weight in the study, diet, type of food, frequency of vomiting (O'Reilly et al., 2011; Provasi et al., 2021; Zimmerman & Barlow, 2012). For the final version of the form, opinions were received from 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. | First measurement- At 15 minutes after admission in the study | |
Primary | COMFORT Scale | The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Basbakal, & Yalaz, 2014). | First measurement: T0: just before the intervention | |
Primary | Newborn Follow-up Form | This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic. | First measurement: T0: just before the intervention | |
Secondary | COMFORT Scale | The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Basbakal, & Yalaz, 2014). | Second measurement: T1: 15th minute of the intervention | |
Secondary | Newborn Follow-up Form | This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic. | Second measurement: T1: 15th minute of the intervention | |
Secondary | COMFORT Scale | The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Basbakal, & Yalaz, 2014). | Third measurement: T2: 30th minute of the intervention | |
Secondary | Newborn Follow-up Form | This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic. | Third measurement: T2: 30th minute of the intervention | |
Secondary | COMFORT Scale | The COMFORT Scale was developed by Ambuel et al. (1992) to determine the comfort and distress of patients in the pediatric intensive care unit. The comfort of the newborn is evaluated through 7 parameters, including muscle tone, calmness/agitation, facial tension, body movements, crying, and respiratory response with YKDS. If the newborn receives mechanical ventilator support, "respiratory response" is scored, and if the newborn is breathing spontaneously, "crying" items are scored. For this reason, the overall scoring of the scale is based on 6 items, and the scores that can be obtained from the scale vary between 6 and 30. A low score from the scale indicates comfort, while an increase in score indicates pain or distress in the newborn (Kahraman et al., 2014; Van Dijk et al., 2009). The Turkish validity and reliability study of YKDS was conducted by Kahraman et al. in 2014 (Kahraman, Basbakal, & Yalaz, 2014). | Fourth measurement: T3: 15 minutes after the end of the intervention | |
Secondary | Newborn Follow-up Form | This form, created by the researchers, contains information on physiological parameters (heart rate, respiratory rate, and oxygen saturation) and cerebral rSO2 values (Provasi et al., 2021; Zimmerman & Barlow, 2012). The information in the Follow-up Form was evaluated just before the intervention (TO), at the 15th minute of the intervention (T1), at the 30th minute of the intervention (T2), and 15 minutes after the intervention (T3). The form was finalized by taking the opinions of 2 nurses and 1 neonatology specialist, who are experts in pediatric nursing. Physiological parameters of the newborn were followed from the Philips IntelliVue MP40 branded neonatal monitor suitable for neonatal use, and cerebral rSO2 was monitored with the INVOS™ 5100C Cerebral/Somatic Oximeter brand NIRS device available in the clinic. | Fourth measurement: T3: 15 minutes after the end of the intervention |
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