NCT03423914

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 mother's interaction with her infant.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

January 18, 2018

Last Update Submit

February 20, 2020

Conditions

Keywords

writingpostraumatic stresscoping

Outcome Measures

Primary Outcomes (1)

  • Posttraumatic stress

    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 Outcomes (1)

  • Coping and adaptation

    fifth day

Study Arms (2)

Writing Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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

Writing Intervention Group

Participants write about knowledge related to infant care during four days

Control Group

Eligibility Criteria

Age14 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Santander

Bucaramanga, International, 68, Colombia

Location

Related Publications (4)

  • Hawes K, McGowan E, O'Donnell M, Tucker R, Vohr B. Social Emotional Factors Increase Risk of Postpartum Depression in Mothers of Preterm Infants. J Pediatr. 2016 Dec;179:61-67. doi: 10.1016/j.jpeds.2016.07.008. Epub 2016 Aug 5.

    PMID: 27502105BACKGROUND
  • Aftyka A, Rybojad B, Rosa W, Wrobel A, Karakula-Juchnowicz H. Risk factors for the development of post-traumatic stress disorder and coping strategies in mothers and fathers following infant hospitalisation in the neonatal intensive care unit. J Clin Nurs. 2017 Dec;26(23-24):4436-4445. doi: 10.1111/jocn.13773. Epub 2017 Apr 20.

    PMID: 28231614BACKGROUND
  • Yang YY, He HG, Lee SY, Holroyd E, Shorey S, Koh SSL. Perceptions of Parents With Preterm Infants Hospitalized in Singaporean Neonatal Intensive Care Unit. J Perinat Neonatal Nurs. 2017 Jul/Sep;31(3):263-273. doi: 10.1097/JPN.0000000000000239.

    PMID: 28234668BACKGROUND
  • Wormald F, Tapia JL, Torres G, Canepa P, Gonzalez MA, Rodriguez D, Escobar M, Reyes B, Capelli C, Menendez L, Delgado P, Treuer S, Ramirez R, Borja N, Dominguez A; Neocosur Neonatal Network (Red Neonatal Neocosur). Stress in parents of very low birth weight preterm infants hospitalized in neonatal intensive care units. A multicenter study. Arch Argent Pediatr. 2015 Aug;113(4):303-9. doi: 10.5546/aap.2015.eng.303. English, Spanish.

    PMID: 26172004BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Martha Camargo, RN-MsC

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
random allocation of the mother to the control or intervention group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Mixed study, where the quantitative and qualitative. From the quantitative is an experimental study type controlled clinical trial. From the qualitative it will be interpretive phenomenological
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Nursing Professor

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 6, 2018

Study Start

October 1, 2017

Primary Completion

July 30, 2018

Study Completion

November 30, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations