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The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04966286
Collaborator
(none)
108
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: multimedia education
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effectiveness of Applying Multimedia on Self-Care and Quality of Life in Patient With Enterostomy
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Mar 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: conventional education service program

received only standard enterostomy care brochure

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
Experimental: multimedia education service program

received multimedia education service program introduction

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

Outcome Measures

Primary Outcome Measures

  1. self-care ability [One and a half years]

    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

Secondary Outcome Measures

  1. Promote quality of life [One and a half years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age ≧ 20

  • Operation with ostomy

Exclusion Criteria:

  • Dementia, mental illness, and central nervous system diseases

  • Unable self-care

  • Visual or hearing impairs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hsing Fang Ko Kaohsiung Taiwan

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04966286
Other Study ID Numbers:
  • 7425
First Posted:
Jul 19, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2021