Study objective: To determine the impact of the empowerment program on stress, anxiety and depression in mothers of infants with Colostomy
- Design study: a double-blind study, selected hospitals were randomly assigned to intervention and control groups
- the main criteria to enter the study:the willingness of women to participate in training sessions; ranging in age from newborn to age is 28-0 days; any disease of the digestive system that needs to be treated as a temporary colostomy may be
- the main criteria to Exclusion the study: The baby died; refused to continue working mother of; Failure to attend at least two training sessions for the intervention group
Sample size: 21 single mothers in the intervention group and control group
Intervention Study: Empowering intervention the day after surgical by the researcher and the teaching of verbal and face to face with the mother in the NICU is done. The intervention included training sessions for 30 to 45 minutes depending on the number of sessions required will be determined by participants. Session One: Introduction to the gastrointestinal tract and fecal excretion route and need colostomy surgery and its potential problems (inflammation, infection, necrosis and decay and peeled the skin around the colostomy prolapse, retraction, dehydration and possible bleeding), the second session of practical care Practical care of the baby and about how colostomy bag or diaper refill and use, eliminating the smell of feces and skin care practices, infant bath, stool consistency according to the method of feeding and dressing and infection control and monitoring three session: the role of maternal and infant care by the mother.
-Intervention from the day after surgery until discharge
-primary out come variable: stress, anxiety and depression in mothers
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060417972N1
Registration date:2014-07-19, 1393/04/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Zahra Godarzi
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4407
Email address
godarziz@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tehran University of Medical Sciences
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2014-09-20, 1393/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Empowerment program on stress, anxiety and depression in mothers of infants with colostomy
Public title
Effect of Empowerment program on stress, anxiety and depression in mothers of infants with colostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the willingness of women to participate in training sessions; ranging in age from newborn to age is 28-0 days; any disease of the digestive system that needs to be treated as a temporary colostomy may be. Exclusion criteria: The baby died; refused to continue working mother of; Failure to attend at least two training sessions for the intervention group
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd Tehran Research Office, 7th Floor
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93121781633633
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
k91.4
ICD-10 code description
Abcess, malfuntoin, prolaps, complication
Primary outcomes
1
Description
Stress
Timepoint
Before the intervention and one month after intervention
Method of measurement
Questionnaire dass 21
2
Description
Anexiety
Timepoint
Before the intervention and one month after intervention
Method of measurement
Did you mean: پرسشنامه dass 21
3
Description
Depresion
Timepoint
Before the intervention and one month after intervention
Method of measurement
Did you mean: پرسشنامه dass 21
Secondary outcomes
empty
Intervention groups
1
Description
The intervention training is include review digestion system and defecation route and need colostomy surgery and possible problems it (Inflammation, infection, necrosis and decay and peeled the skin around the colostomy, colostomy prolapse, retraction colostomy, dehydration and possible bleeding) and training on how to refill and use baby care and colostomy bags, diapers, eliminate the odor of feces and skin care, to infant bath, attention stool consistency, the method of feeding and dressing(colostomy how to keep children from accessing it), and infection control and monitoring development and family travel and mother's role. At the end a booklet based on a review of literature, infants have a colostomy is given.
Category
Other
2
Description
The group control will take routing care include changing diaper and care of skin around colostomy only oral education by a nurse at the time of discharge from NICU without practical education and booklet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal intensive care unit of Children's Hospital Medical Center
Full name of responsible person
Ms.goldost, headnurse
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Ali Asghar Hospital neonatal intensive care unit
Full name of responsible person
Ms.shojaee,Master of Nursing,haed nurse
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Bahrami Children's Hospital neonatal intensive care unit
Full name of responsible person
Ms.nori,head nurse
Street address
City
tehran
4
Recruitment center
Name of recruitment center
mofid hospital neonatal intensive care unit of beneficial
Full name of responsible person
Ms.ghafari,head nurse
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Research Office
Full name of responsible person
Tehran University Research Office
Street address
Keshavarz Blvd, over six floors, ghods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University Research Office
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra godarzi
Position
Master of nursing
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6105 4432
Fax
Email
godarziz@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran
Full name of responsible person
Zahra godarzi
Position
Master of Nursing faculty
Other areas of specialty/work
Street address
Tohid Square, Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6105 4432
Fax
Email
godarziz@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)