Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03423914
Status:
UNKNOWN
Last Update Posted:
2020-02-21
First Post:
2018-01-18
Brief Title:
Efficacy of Expressive Writing in Mothers of Preterm Infants
Sponsor:
Universidad Industrial de Santander
Organization:
Universidad Industrial de Santander
Study Overview
Official Title:
Efficacy of Expressive Writing in Mothers of Hospitalized Preterm Infants
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Premature birth can lead the mother to lose control of herself and be a contributor to the psychological stress experienced due to the sudden breakdown of the interaction with her infant because of hospitalization in a neonatal care unit This is a mixed method study the aim is establish the effectiveness of expressive writing in the experience of mothers of hospitalized preterm infants The intervention Expressive writing therapy could contribute to reduce the level of stress and anxiety improving coping and the mothers interaction with her infant
Detailed Description:
Background The literature has shown the application of expressive writing therapy after traumatic events and the measurement of its impact on peoples health through the application of quantitative instruments However no studies have been carried out in which this therapeutic activity has been measured with quantitative methods and at the same moment to measure the experience using qualitative analysis that allows to understand in depth the human experience Expressive writing therapy could contribute to reducing the level of stress and anxiety improving coping and the interaction of the mother with her premature newborn PNTBs In this sense it is necessary to have a scientific research in this area from a qualitative-quantitative approach allows demonstrating the reach of positive effects in the emotional health status of mothers with PTNBs hospitalized in a neonatal care unit NICU
General purpose To establish the effectiveness of expressive writing in the experience of mothers of hospitalized preterm infants
Specific objectives
Establish the coping capacity of the mothers of the premature Infants before and after the intervention
Determine the level of post-traumatic stress of the mothers of the premature Infants before and after the intervention
Establish the performance of the maternal role of the mothers of the premature Infants before and after the intervention
Describe how mothers of RNPT experience the experience of having their child hospitalized
Understand the meaning of the mothers experience in the transition to the maternal role of a premature
Design Mixed study where the quantitative and qualitative method is used Which allows to combine the two paradigms to approach in a more integral way to the research problematic In this sense the research will be strengthened to be able to incorporate data from the writing of the participants to give greater meaning to the numerical data From the quantitative is an experimental study type controlled clinical trial From the qualitative it will be interpretative phenomenological philosophical methodology that allows to discover and understand the meaning of human experience around a phenomenon
For the measurement of the results before and after the intervention the Nursing Outcome -NOC Performance of the maternal role 2211 will be applied to both groups In the experimental group the Nursing Intervention will be applied- NIC Journalist 4740
Population of study Mothers with premature newborns hospitalized in the neonatal care unit at third level Hospital in Bucaramanga Colombia
Sample Size For the quantitative design the sample size was calculated taking into account according to previous studies the change of 25 in the PST scale to achieve a decrease in the levels of post-traumatic stress This study will randomly allocate 60 premature infants mothers 30 for each group with a power of 80 and an alpha of 005 For the qualitative design convenience sampling will be taken into account from the writings made by the mothers of the intervention group
Inclusion Criteria Mothers with
Age of 14 or more years old
Preterm newborns with a gestational age of less than 34 weeks
Preterm newborns who are hospitalized in the NICU of the Third level Hospital of Santander
Preterm newborns alive at the time of assignment to the control group or intervention group
The time of hospitalization of the newborn must be at least one week in the hospital institution
Nursing Diagnosis Readiness of enhanced parenting 00164
Exclusion Criteria
Mother with
Limitations like as hearing motor and or mental disability - measured through the minimental test
Consumption of psychoactive substances
Mothers who can not read or write
Newborns with a confirmed diagnosis of severe diseases as a congenital malformations
Instruments Coping level scale Perinatal posttraumatic stress scale maternal role performance scale Minimental test
General purpose To establish the effectiveness of expressive writing in the experience of mothers of hospitalized preterm infants
Specific objectives
Establish the coping capacity of the mothers of the premature Infants before and after the intervention
Determine the level of post-traumatic stress of the mothers of the premature Infants before and after the intervention
Establish the performance of the maternal role of the mothers of the premature Infants before and after the intervention
Describe how mothers of RNPT experience the experience of having their child hospitalized
Understand the meaning of the mothers experience in the transition to the maternal role of a premature
Design Mixed study where the quantitative and qualitative method is used Which allows to combine the two paradigms to approach in a more integral way to the research problematic In this sense the research will be strengthened to be able to incorporate data from the writing of the participants to give greater meaning to the numerical data From the quantitative is an experimental study type controlled clinical trial From the qualitative it will be interpretative phenomenological philosophical methodology that allows to discover and understand the meaning of human experience around a phenomenon
For the measurement of the results before and after the intervention the Nursing Outcome -NOC Performance of the maternal role 2211 will be applied to both groups In the experimental group the Nursing Intervention will be applied- NIC Journalist 4740
Population of study Mothers with premature newborns hospitalized in the neonatal care unit at third level Hospital in Bucaramanga Colombia
Sample Size For the quantitative design the sample size was calculated taking into account according to previous studies the change of 25 in the PST scale to achieve a decrease in the levels of post-traumatic stress This study will randomly allocate 60 premature infants mothers 30 for each group with a power of 80 and an alpha of 005 For the qualitative design convenience sampling will be taken into account from the writings made by the mothers of the intervention group
Inclusion Criteria Mothers with
Age of 14 or more years old
Preterm newborns with a gestational age of less than 34 weeks
Preterm newborns who are hospitalized in the NICU of the Third level Hospital of Santander
Preterm newborns alive at the time of assignment to the control group or intervention group
The time of hospitalization of the newborn must be at least one week in the hospital institution
Nursing Diagnosis Readiness of enhanced parenting 00164
Exclusion Criteria
Mother with
Limitations like as hearing motor and or mental disability - measured through the minimental test
Consumption of psychoactive substances
Mothers who can not read or write
Newborns with a confirmed diagnosis of severe diseases as a congenital malformations
Instruments Coping level scale Perinatal posttraumatic stress scale maternal role performance scale Minimental test
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