Premature InfantNCT03423914
Efficacy of Expressive Writing in Mothers of Preterm Infants
A study testing Expressive writing and Only Writing in people with Premature Infant and Mothers, run by Universidad Industrial de Santander at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 49 years, women only
- Conditions the study is for
- Premature Infant, Mothers
- What is being tested?
- Expressive writing and Only Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteColombia
- Study dates
- 1 Oct 2017to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario de Santander
Bucaramanga, International, 68
About this study
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.
Read the 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
- Conditions
- Premature Infant, Mothers
- Being tested
- Expressive writing, Only Writing
- Keywords
- writing, postraumatic stress, coping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
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
Only WritingOther
Participants write about knowledge related to infant care during four days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Only Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: fifth day
Secondary outcomes (1)
Coping and adaptation
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
Measured: fifth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Oct 2017
- Primary completion30 Jul 2018
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Isabel Camargo, Universidad Industrial de Santander
- Investigators
- Martha Camargo, RN-MsC, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423914
- Sponsor's protocol ID
- 10620
- Status last verified
- Feb 2020
- First submitted
- 18 Jan 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The publication of the results of this study will be carried out in an indexed journal and in scientific events.
Publications
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.
PubMed 27502105Aftyka 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.
PubMed 28231614Yang 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.
PubMed 28234668Wormald 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.
PubMed 26172004
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Expressive Writing in Mothers of Hospitalized Preterm Infants
- ClinicalTrials.gov ID
- NCT03423914
- Acronym / sponsor ID
- 10620
- Conditions
- Premature Infant, Mothers
- Keywords
- writing, postraumatic stress, coping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Writing Intervention Group | Experimental | Behavioral: Expressive writingExpressive 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. |
| Control Group | Active comparator | Other: Only WritingOnly Writing The participants will write about situations not related to the subjective human experience of their preterm birth, but about general aspects. |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingThe 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 | Behavioural | Writing Intervention Group |
| Only WritingParticipants write about knowledge related to infant care during four days | Other | Control Group |
Primary outcome
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
1 secondary outcome
Coping and adaptation
Time frame: fifth day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Background: PubMed 27502105Hawes 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.
- Background: PubMed 28231614Aftyka 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.
- Background: PubMed 28234668Yang 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.
- Background: PubMed 26172004Wormald 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.
- Individual participant dataSharing planned: Undecided. The publication of the results of this study will be carried out in an indexed journal and in scientific events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha Camargo, RN-MsC principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing and Only Writing in people with Premature Infant and Mothers, run by Universidad Industrial de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic stress (time frame: fifth day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423914, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.