Efficacy of Expressive Writing in Mothers of Preterm Infants

February 20, 2020 updated by: Martha Isabel Camargo, Universidad Industrial de Santander

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • International
      • Bucaramanga, International, Colombia, 68
        • Hospital Universitario de Santander

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 at the hospital.
  • Nursing Diagnosis Readiness for enhanced parenting (00164)

Exclusion Criteria:

  • Limitations as hearing, motor and / or mental disability measured through the minimenta test.
  • Active consumption of psychoactive substances
  • Mothers who can not read or write,
  • Mothers of newborns with a confirmed diagnosis of severe diseases like congenital malformations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Writing Intervention Group
Expressive writing The participant will write four days about her deepest thoughts and feelings in relation to the experience of hospitalization of the premature newborn and how this experience is related to your current life and to your future.
Behavioral: Expressive writing
The emotional or expressive writing therapy developed by James Pennebaker has been used as a method of self-understanding in people with high levels of stress, chronic diseases, sexual and physical abuse, natural disasters and job loss, among others. Expressive writing allows and implies revealing the deepest thoughts and feelings of the person about a stressful or traumatic event in life translate emotions into words, and with that, reduce mental stress (decrease in levels of depression, stress and anxiety), strengthen self-esteem and even strengthen the immune system
ACTIVE_COMPARATOR: Control Group
Only Writing The participants will write about situations not related to the subjective human experience of their preterm birth, but about general aspects.
Other: Only Writing
Participants write about knowledge related to infant care during four days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Posttraumatic stress
Time Frame: fifth day
Decreased of stress in mothers. It will be measure using the Postnatal Perinatal Stress Scale, a 14-item questionnaire that examines maternal perinatal post-traumatic stress symptoms specific to childbirth. The scores range between 0 and 14; but a score of 6 would qualify for a diagnosis of PTSD
fifth day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coping and adaptation
Time Frame: fifth day
Improve coping and adaptacion in mothers of premature infants. Level of coping scale: It is the instrument that allows the identification of coping and adaptation strategies used by people to face difficult situations. It is a measurement scale that contains 33 indicators each with 4 Likert type response options from never to always. Each item is a short phrase that describes how a person responds when they have a critical or difficult situation
fifth day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Industrial de Santander

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martha Camargo, RN-MsC, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10620 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The publication of the results of this study will be carried out in an indexed journal and in scientific events.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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