The effect of expressive writing on posttraumatic stress disorder and hopelessness in mothers with premature neonate hospitalized in Neonatal Intensive Care Unit
The effect of expressive writing on PTSD and hopelessness in mothers with premature neonate
Design
A non-randomized clinical trial with control and intervention groups on 70 mothers with premature babies
Settings and conduct
Location: the NICU of Esfahan Shahid Beheshti Hospital. The demographic information questionnaire of the mother and the baby will be completed during the first week after delivery. Then during the fourth week using the PPQ and Beck hopelessness questionnaire; Mothers with a score higher than six from the PPQ and any score from the Beck Questionnaire (because it does not have a cutoff point) will be included in the study. The expressive writing and how to write it for the intervention group is explained and they are asked to write in a private and quiet place, regardless of grammar about their deepest feelings and thoughts regarding the birth and hospitalization of their baby in the NICU . Writing three times a week (every other day) and each time will be for at least 15 minutes. The control group will only receive routine care. Then, after two to four weeks , PPQ and Beck's questionnaire will be completed again by the mothers of the two groups and they will be compared with before the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-year-old,literate,with premature babies, a score higher than six in the PPQ
Exclusion criteria: history of suffering from PTSD, addiction and hospitalization of the baby for less than ten days
Intervention groups
In order to prevent the exchange of information, first all mothers who meet the entry criteria will be selected as the control group. After the discharge of the control group, sampling of the intervention group will begin. The control group does not receive any intervention and the intervention group will write expressive writing.
Main outcome variables
Posttraumatic stress disorder, Hopelessness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230305057623N1
Registration date:2023-04-15, 1402/01/26
Registration timing:prospective
Last update:2023-04-15, 1402/01/26
Update count:0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
Behnaz Soltanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 8095
Email address
b.soltanpour@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-04, 1402/02/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of expressive writing on posttraumatic stress disorder and hopelessness in mothers with premature neonate hospitalized in Neonatal Intensive Care Unit
Public title
The effect of expressive writing on stress and hopelessness in mothers with premature neonate
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers 18 years and older if they want to participate in the research
Being literate (having at least a high school education)
Iranian and fluent in Persian language
Mothers with premature neonate less than 37 weeks
Obtaining a score higher than six from the PPQ questionnaire
Not having a hearing problem
Exclusion criteria:
History of post-traumatic stress disorder
Drug addiction, use of anti-anxiety and depression or psychotropic drugs up to one month before sampling
Existence of acute stressful situations during the last six months
A history of being in the NICU and having a premature baby
Mothers' use of other stress reduction methods
Taking care of the baby by other family members other than the mother
Genetic disease in the baby
Hospitalization of the baby less than ten days
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
Professor Hesabi Boulevard, Safaeiye
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.SSU.REC.1401.103
Health conditions studied
1
Description of health condition studied
posttraumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
2
Description of health condition studied
Hopelesness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-traumatic stress disorder
Timepoint
During the fourth week after birth (first stage) and after two to four weeks of the first stage
During the fourth week after birth (first stage) and after two to four weeks of the first stage
Method of measurement
Beck Hopelessness Questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the mothers in the intervention group are asked to write in a private and quiet place, regardless of grammar about their deepest feelings and thoughts regarding the birth and hospitalization of their baby in the intensive care unit.
Category
Other
2
Description
Control group: There is no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Behnaz Soltanpour
Street address
Shahid Motahari Ave
City
Esfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3236 7001
Email
beheshti@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghuei
Street address
Shahid Docror Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
samat@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?