Comparitive study on the effects of simulation and demonstration-return demonstration methods in ostomy care training on self-efficacy and adjustment in patients with an intestinal stoma
This study is a single-blind randomized trial with two groups of pre- and post-test. The aim of study is Comparison the effects of simulation and demonstration-return demonstration methods in ostomy care training on self-efficacy and adjustment in patients with an intestinal stoma. The study population included patients with intestinal ostomy (colostomy or ileostomy). Inclusion criteria Includes having healthy vision and hearing and having no disability, psychological disorders and dependence for their cares. Exclusion criteria include complication and Unwillingness to continue to participate in the study. The total sample size is 23 patients per group so 46 patients in both group were considered. In this study, the intervention will be carried out in separate groups, one group educate with simulation method and another group educate with demonstration- return demonstration. For each group 4 training at the clinic will be held at approximately 0.5 hours (3 sessions as individual theory and practice training and the last session as a meeting group about ostomy care). Simulation group Practice ostomy cares on designed simulator based on simulation methods and demonstration- return demonstration group display Cares on their own ostomy based on demonstration- return demonstration method. Outcomes of study are self-efficacy and ostomy adjustment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014113020162N1
Registration date:2015-04-04, 1394/01/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
Zohre Pouresmail
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3662 9069
Email address
pouresmailz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-05, 1394/01/16
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparitive study on the effects of simulation and demonstration-return demonstration methods in ostomy care training on self-efficacy and adjustment in patients with an intestinal stoma
Public title
Ostomy care education to patients with intestinal ostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for patients recently have ostomy surgery: Between 18 and 65 years old; Patient that Singed Consent Knowingly; Having healthy vision and hearing and having no disability; Have no psychological disease, movement disability and balance disorders; Have no experience of having intestinal ostomy in family members; Do not receive any regular and documented ostomy training.
Inclusion criteria for patients who already have ostomy surgery: Between 18 and 65 years old; Patient that Singed Consent Knowingly. Exclusion criteria: Willingness to continue participation in the study; Complications that commonly affect the Regular care and need to hospitalization; Patient death
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
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
Mashhad University of Medical Sciences
Street address
Vice Chancellor for research, Ghoraishy Building, University St, Mashhad
City
Mashhad
Postal code
9177899191
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
930866
Health conditions studied
1
Description of health condition studied
Ineffective training
ICD-10 code
Z55.8
ICD-10 code description
other problems related to education and literacy
Primary outcomes
1
Description
Self efficacy
Timepoint
Before the intervention, after the intervention, 1.5 month after intervention
Method of measurement
self efficacy questionnaire
Secondary outcomes
1
Description
adjustment
Timepoint
Before the intervention,After the intervention, 1.5 month after intervention.
Method of measurement
Ostomy adjusment inventory 23 questionnaire
Intervention groups
1
Description
Intervention1: The demonstration- return demonstration ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration and The importance of leakage prevention. In the second session, patient educated about how to change the ostomy pouch and care of skin that around the ostomy with demonstration method and patient practice cutting ostomy bag by return demonstration. This session held 1-3 days after the first session. In third session, patient change ostomy pouch and skin care around the ostomy without nurse aid by return demonstration. Researcher completes teaching flow sheet. The session will be held one week after the second session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The group members discuss and respond to each other’s questions. The meeting will be held one week after the third session.
Category
Other
2
Description
intervention2: The simulation ostomy care training is done in 4 sessions, in the first session teach about the types of ostomy, diet, bathing, authorized and unauthorized activities and warning signs, gas and odor control in colostomy, signs and symptoms of dehydration The importance of leakage prevention leakage. Then video will be witch contains ostomy bag substitute teaching and patient practice how to cut the adhesive ostomy bag. In the second session patient learning how to change the ostomy pouch and skin care around the ostomy. Patient participates in Skin care with the physical simulators. The session will be held 1-3 days after the first session. In the fourth session common complication of ostomy and how to prevent them educated by PowerPoint software. The meeting will be held one week after the third session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Quaem hospital
Full name of responsible person
Ghasem Rahmanian
Street address
Ahmad abad St, Dr Shariati Square, Mashhad.
City
Mashhad
2
Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Fatemeh Kavousi
Street address
Alandasht Square, Kuhsangi St, Mashhad.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice Chancellor for research, Ghoraishy Building, University St, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Name of organization / entity
Mashhad University of Medical Sience
Full name of responsible person
Zohre Pouresmail
Position
Master Student
Other areas of specialty/work
Street address
Number 69,South Adibe 1 St, Ghasem abad, Mashhad.
City
Mashhad
Postal code
9189633798
Phone
+98 935 539 2288
Fax
Email
pouresmailz921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sience
Full name of responsible person
Fateme Heshmati Nabavi
Position
Phd in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Doctora Crossroads, Mashhad.
City
Mashhad
Postal code
9137913199
Phone
+98 915 500 2213
Fax
+98 985138591511
Email
heshmatinf@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sience
Full name of responsible person
Zohre Pouresmail
Position
Master Student
Other areas of specialty/work
Street address
Number 69,South Adibe 1 St, Ghasem abad, Mashhad.
City
Mashhad
Postal code
9189633798
Phone
+98 935 539 2288
Fax
Email
pouresmailz921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)