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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966286
Other study ID # 7425
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date March 31, 2019

Study information

Verified date June 2021
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This report was an effective evaluation of using multimedia educational program for self-care and quality of life in patients with a stoma at postoperative and established a simple threshold for enterostomy self-care skills.


Description:

In a systematic review, evaluated the effectiveness of multimedia education program (MLEP) and confirmed that MLEP reduced cost significantly and improved patient participation in enterostomy care and self-care ability. However, research was insufficient for whether a multimedia education program (MLEP) interventions can improve patient self-care and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - Age ? 20 - Operation with ostomy Exclusion Criteria: - Dementia, mental illness, and central nervous system diseases - Unable self-care - Visual or hearing impairs

Study Design


Related Conditions & MeSH terms


Intervention

Other:
multimedia education
The MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes

Locations

Country Name City State
Taiwan Hsing Fang Ko Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary self-care ability Assessment scale of self-care ability of enterostomy care was a quantitative scale for nursing staff to evaluate self-care skills in patients with enterostomy. It consisted of 7 items related to: Prepare items, removing the pouching system, measuring the enterostomy diameter, adjusting the size of the enterostomy diameter in a new stoma appliance, skin care, fitting a new enterostomy appliance, and emptying procedure. Each skill was rated on a 4-point scale: Likert scale (1: not at all, 2: some, 3: quite a lot, 4: very much).
Higher scores indicated that patient had a higher level of self-care skills for changing enterostomy pouching system
One and a half years
Secondary Promote quality of life The Enterostomy quality of life was comprised of 30 questionnaires, it covered seven domains: relations with family and friends, Sleep, activity, sexual activity, social relationship, physiology and psychology. The responses rated on a4-point scale Likert scale (1: extremely, 2: quite a lot, 3: somewhat, 4: not at all). The possible scores range was from 37 to 148. Higher scores indicated that patient had a higher level of quality of life One and a half years
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