Premature Infant Clinical Trial
Official title:
Efficacy of Expressive Writing in Mothers of Hospitalized Preterm Infants
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 mother's interaction with her infant.
Background: The literature has shown the application of expressive writing therapy after
traumatic events, and the measurement of its impact on people´s 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 mother's 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 2.5 in the PST scale to achieve a decrease in the
levels of post-traumatic stress. This study will randomly allocate 60 premature infant´s
mothers, 30 for each group, with a power of 80% and an alpha of 0.05. 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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02550054 -
Erythropoietin in Premature Infants to Prevent Encephalopathy
|
Phase 2 | |
Completed |
NCT03827252 -
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
|
||
Active, not recruiting |
NCT03345069 -
Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
|
||
Completed |
NCT04067206 -
The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
|
N/A | |
Completed |
NCT03911674 -
Effects of Oral Stimulation in Preterm Infants
|
Phase 3 | |
Completed |
NCT03324126 -
Individualized Fortification of Breast Milk
|
N/A | |
Completed |
NCT03704012 -
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
|
N/A | |
Active, not recruiting |
NCT03241082 -
Ultrasound Assessment of BC in the NICU
|
||
Completed |
NCT03701906 -
Effect of a Mixture of New Probiotic Strains in Preterm Infants
|
N/A | |
Completed |
NCT02133716 -
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
|
Phase 4 | |
Not yet recruiting |
NCT05543005 -
Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
|
N/A | |
Recruiting |
NCT03852641 -
Feeding Premature Infants During Non-invasive Respiratory Support
|
N/A | |
Recruiting |
NCT04648787 -
A Study of Family-integrated Care for Reducing Uncertainty
|
N/A | |
Recruiting |
NCT04866342 -
Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor
|
N/A | |
Not yet recruiting |
NCT02601872 -
Erythropoietin in Premature Infants to Prevent Encephalopathy
|
Phase 2 | |
Not yet recruiting |
NCT02534090 -
Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy
|
N/A | |
Recruiting |
NCT06212427 -
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
|
N/A | |
Suspended |
NCT03939169 -
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
|
N/A | |
Completed |
NCT03726697 -
Effect of Tahneek on Hypoglycemia in Newborn Infants
|
N/A | |
Completed |
NCT03683316 -
Work of Breathing and Kangaroo Mother Care
|