Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830150
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2021-03-30
Brief Title:
The Effect of Supportive Nursing Interventions of Mothers of Infants in Neonatal Intensive Care Unit
Sponsor:
TC ORDU ÜNİVERSİTESİ
Organization:
TC ORDU ÜNİVERSİTESİ
Study Overview
Official Title:
The Effect of Supportive Nursing Interventions on Reducing Stress Levels of Mothers of Infants in Neonatal Intensive Care Unit A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit NICU
Backround The inability to nurture the healthy baby dreamed of disease and intensive care processes are situations causing a crisis for parents The stress experienced by mothers may affect emotional status and the foundation of the mother-ınfant attachment For this reason mothers of infants hospitalized in the NICU need support to cope with the stressful events they experience
Design This study was a prospective pre-and post-test randomised controlled trial Methods The population of the research comprised mothers with neonates admitted to the NICU of a state hospital abiding by the sample selection criteria and who accepted participation in the research The research was completed with 85 mothers in two groups of 45 subjects and 40 controls selected at random Data collection used the Parental Stressor Scale Neonatal Intensive Care Unit PSSNICU NICU Parent Belief Scale NICUPBS State-Trait Anxiety Inventory STAI TX-2 and saliva cortisol analysis
Backround The inability to nurture the healthy baby dreamed of disease and intensive care processes are situations causing a crisis for parents The stress experienced by mothers may affect emotional status and the foundation of the mother-ınfant attachment For this reason mothers of infants hospitalized in the NICU need support to cope with the stressful events they experience
Design This study was a prospective pre-and post-test randomised controlled trial Methods The population of the research comprised mothers with neonates admitted to the NICU of a state hospital abiding by the sample selection criteria and who accepted participation in the research The research was completed with 85 mothers in two groups of 45 subjects and 40 controls selected at random Data collection used the Parental Stressor Scale Neonatal Intensive Care Unit PSSNICU NICU Parent Belief Scale NICUPBS State-Trait Anxiety Inventory STAI TX-2 and saliva cortisol analysis
Detailed Description:
This study was performed with the aim of determining the effect of supportive interventions on maternal stress levels among mothers with infants hospitalized in the NICU
This was a randomized pre- and post-test controlled trial was conducted to determined the effect of planned educational and supportive nursing interventions given to mothers with infants in the NICU on the stress anxiety and beliefs of mothers in the NICU of Women and Pediatrics Training and Research Hospital This study was conducted at a state hospitals NICU in the east part of Turkey According to the criteria of the TR Ministry of Health the unit in which the study was performed was a Level I NICU The unit had 10 incubators and 10 nurses were employed in the NICU The nurses in the NICU worked in groups of three in two shifts providing care and treatment of the newborns in the unit This part of Turkey is geographically located in a rural area in the east The mothers with infants in the NICU were informed by the physicians and nurses on certain days of the week about the hours at which they were allowed to visit their infants
Power analysis of the sample number used the GPower v 3192 program and was based on previous studies According to Jacob Cohens effect size coefficients assuming large effect size in assessments between two independent groups d040 with α005 and 1-β095 90 power each group was required to contain at least 39 people Considering data loss each group included 50 mothers As saliva samples were insufficient in 10 mothers in the experiment group and 5 mothers in the control group this data was excluded from the study The research was completed with 85 mothers comprising 40 subjects and 45 controls chosen at random Fig 1
23 Randomization sequence generation type allocation concealment mechanism and implementation Randomization was performed using a computer program The participants were randomised and assigned by a researcher into two groups using the Integer Generator free software wwwrandomorg which produces random numbers in configurable intervals 40 in intervention group and 45 in control group
Data collection used the Mother and Neonate Descriptive Information Form Parental Stressor Scale Neonatal Intensive Care Unit PSSNICU NICU Parent Belief Scale NICU PBS State-Trait Anxiety Inventory STAI TX-2 and saliva cortisol analysis
Before the mothers first visits to their infants the mother and neonate descriptive information form PSS NICU STAI TX-2 and NICU Parent Belief scale were completed by the researcher during face-to-face interviews with the mother and first saliva samples were taken from mothers Mothers in the group with supportive nursing interventions completed the PSSNICU NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken when their infants were discharged from the NICU
Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following the NICU was physically described to mothers on the first day they visited their infants mothers were introduced to team members and given information about how to obtain information about their baby visiting hours and conditions Special tools and devices required for care like respiratory devices and monitors were described and information was given about treatment of the neonate and general status Mothers of neonates with appropriate clinical status were encouraged to touch their baby and hold their hand Within the rules of the unit mothers were allowed to touch and hold their baby Introduction to the NICU informing about the baby and contact between mother and baby was completed within 30-45 minutes duration As a guide to training a 35-page Care of your Baby in the Neonatal Intensive Care Unit training booklet prepared by the researcher based on stress among families in the intensive care unit was given to mothers and included topics like the NICU environment features of neonates born prematurely and at term care feeding diseases treatment methods stress in the NICU breastfeeding preparation for discharge and baby care at home
After the information session on the first visiting day for mothers and babies seven interactive trainings were held each lasting nearly 90 minutes during the neonates admission to hospital During interactive training power point presentations prepared by the researcher were presented on a large screen in the education salon in the hospital and arranged in two 45-minute sessions allowing mothers to share their experiences excitement sadness and worries Planned nursing interventions were standardised for each mother with a check-list Mothers were given information training about the NICU environment features of babies born prematurely and at term care feeding disease treatment methods stress in the NICU breastfeeding preparation for discharge and baby care at home The relevant topics were chosen after relevant literature search by the researcher Konukbay Arslan 2011 Lonio et al 2016 Uludağ Ünlüoğlu 2012 and the second authors personal experience with parents of infants in the NICU In the second session the researchers gave training about positive thinking healthy lifestyle knowing yourself stress management and relaxation techniques developed in the context of the literature within the scope of supportive nursing interventions for mothers Nasiri et al 2018 Nasiri et al 2018 Mothers were taught the simple but powerful relaxation technique which is easy and can be performed nearly everywhere of deep breathing diaphragmatic respiration Each session began with this exercise and they were encouraged to perform it throughout the day
During mothers first visits to their infants mothers in this group had the mother and neonate descriptive information form PSS NICU STAI TX-2 and NICU Parent Belief scale applied and first saliva samples were taken from mothers Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit When their infants were discharged from the NICU mothers completed the PSSNICU NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken
This was a randomized pre- and post-test controlled trial was conducted to determined the effect of planned educational and supportive nursing interventions given to mothers with infants in the NICU on the stress anxiety and beliefs of mothers in the NICU of Women and Pediatrics Training and Research Hospital This study was conducted at a state hospitals NICU in the east part of Turkey According to the criteria of the TR Ministry of Health the unit in which the study was performed was a Level I NICU The unit had 10 incubators and 10 nurses were employed in the NICU The nurses in the NICU worked in groups of three in two shifts providing care and treatment of the newborns in the unit This part of Turkey is geographically located in a rural area in the east The mothers with infants in the NICU were informed by the physicians and nurses on certain days of the week about the hours at which they were allowed to visit their infants
Power analysis of the sample number used the GPower v 3192 program and was based on previous studies According to Jacob Cohens effect size coefficients assuming large effect size in assessments between two independent groups d040 with α005 and 1-β095 90 power each group was required to contain at least 39 people Considering data loss each group included 50 mothers As saliva samples were insufficient in 10 mothers in the experiment group and 5 mothers in the control group this data was excluded from the study The research was completed with 85 mothers comprising 40 subjects and 45 controls chosen at random Fig 1
23 Randomization sequence generation type allocation concealment mechanism and implementation Randomization was performed using a computer program The participants were randomised and assigned by a researcher into two groups using the Integer Generator free software wwwrandomorg which produces random numbers in configurable intervals 40 in intervention group and 45 in control group
Data collection used the Mother and Neonate Descriptive Information Form Parental Stressor Scale Neonatal Intensive Care Unit PSSNICU NICU Parent Belief Scale NICU PBS State-Trait Anxiety Inventory STAI TX-2 and saliva cortisol analysis
Before the mothers first visits to their infants the mother and neonate descriptive information form PSS NICU STAI TX-2 and NICU Parent Belief scale were completed by the researcher during face-to-face interviews with the mother and first saliva samples were taken from mothers Mothers in the group with supportive nursing interventions completed the PSSNICU NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken when their infants were discharged from the NICU
Supportive and educational nursing interventions about reducing maternal stress levels in the experimental group included the following the NICU was physically described to mothers on the first day they visited their infants mothers were introduced to team members and given information about how to obtain information about their baby visiting hours and conditions Special tools and devices required for care like respiratory devices and monitors were described and information was given about treatment of the neonate and general status Mothers of neonates with appropriate clinical status were encouraged to touch their baby and hold their hand Within the rules of the unit mothers were allowed to touch and hold their baby Introduction to the NICU informing about the baby and contact between mother and baby was completed within 30-45 minutes duration As a guide to training a 35-page Care of your Baby in the Neonatal Intensive Care Unit training booklet prepared by the researcher based on stress among families in the intensive care unit was given to mothers and included topics like the NICU environment features of neonates born prematurely and at term care feeding diseases treatment methods stress in the NICU breastfeeding preparation for discharge and baby care at home
After the information session on the first visiting day for mothers and babies seven interactive trainings were held each lasting nearly 90 minutes during the neonates admission to hospital During interactive training power point presentations prepared by the researcher were presented on a large screen in the education salon in the hospital and arranged in two 45-minute sessions allowing mothers to share their experiences excitement sadness and worries Planned nursing interventions were standardised for each mother with a check-list Mothers were given information training about the NICU environment features of babies born prematurely and at term care feeding disease treatment methods stress in the NICU breastfeeding preparation for discharge and baby care at home The relevant topics were chosen after relevant literature search by the researcher Konukbay Arslan 2011 Lonio et al 2016 Uludağ Ünlüoğlu 2012 and the second authors personal experience with parents of infants in the NICU In the second session the researchers gave training about positive thinking healthy lifestyle knowing yourself stress management and relaxation techniques developed in the context of the literature within the scope of supportive nursing interventions for mothers Nasiri et al 2018 Nasiri et al 2018 Mothers were taught the simple but powerful relaxation technique which is easy and can be performed nearly everywhere of deep breathing diaphragmatic respiration Each session began with this exercise and they were encouraged to perform it throughout the day
During mothers first visits to their infants mothers in this group had the mother and neonate descriptive information form PSS NICU STAI TX-2 and NICU Parent Belief scale applied and first saliva samples were taken from mothers Mothers did not have any other intervention applied by the researchers during routine operation while their infants were in the unit When their infants were discharged from the NICU mothers completed the PSSNICU NICU-Parent Belief Scale and STAI-TX-2 again and had the post-test saliva sample taken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None