Multimedia Information for Patients With Renal Biopsy

August 3, 2023 updated by: Ching-Hui Chien, National Taipei University of Nursing and Health Sciences

The Effects of Multimedia Information for Patients With Renal Biopsy

This study takes place in the Divisions of Nephrology. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study takes place in the Divisions of Nephrology at Chang Gung Memorial Hospitals. Patients undergoing renal biopsy were randomized to control group or multimedia information intervention group. The control group received routine care, and the multimedia information intervention group received a multimedia information. Multimedia information intervention is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies. In addition, the investigator also provide face-to-face consultations on answers and clarifications for the content of the videos and telephone consultations to understand the self-care situation of patients on the third day after discharge. After the pre-test, the two groups performed the 1 to 3 post-tests on pre-operation, post-operative day 1 and post-operative day 9. This study used questionnaires that including General Self-Efficacy Scale, Pain Visual Analogy Scale, Visual Analogue Scale for Anxiety, and Positive and Negative Affective Scale. Generalized Estimating Equations (GEEs) will be used to o analyze data.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital at Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients are at least 20 years old
  2. patients need to undergo a renal biopsy
  3. patients can communicate in Chinese or Taiwanese
  4. patients agree to participate in the research and sign the consent form
  5. patients have family members accompanying

Exclusion Criteria:

  1. patients have undergone renal biopsy before
  2. patients have history of mental disorder
  3. patients use anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group received routine care
Experimental: Multimedia information Group
The experimental group received a multimedia information
Other: multimedia information program of renal biopsy
Multimedia information program is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Self-Efficacy Scale
Time Frame: pretest
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
pretest
General Self-Efficacy Scale
Time Frame: post-operative day 9
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
post-operative day 9
Pain Visual Analogy Scale
Time Frame: pretest
It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity
pretest
Pain Visual Analogy Scale
Time Frame: pre-operation
It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.
pre-operation
Pain Visual Analogy Scale
Time Frame: post-operative day 1
It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.
post-operative day 1
Pain Visual Analogy Scale
Time Frame: post-operative day 9
It is an actual straight line of 100 mm, of which 0 mm means no pain at all and 100 mm means extreme pain. A higher score indicates greater pain intensity.
post-operative day 9
Visual Analogue Scale for Anxiety
Time Frame: pretest
It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety
pretest
Visual Analogue Scale for Anxiety
Time Frame: pre-operation
It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety
pre-operation
Visual Analogue Scale for Anxiety
Time Frame: post-operative day 1
It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety
post-operative day 1
Visual Analogue Scale for Anxiety
Time Frame: post-operative day 9
It is an actual straight line of 100 mm, of which 0 mm means no anxiety at all and 100 mm means extreme anxiety. A higher score indicates greater severity of anxiety
post-operative day 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Affective Scale
Time Frame: pretest
It contains a total of 20 items with two subscales including positive affective subscale and negative affective subscale. A 4-point (1-4) scoring method is used. Higher scores represent higher levels of positive and negative affect
pretest
Positive and Negative Affective Scale
Time Frame: post-operative day 9
It contains a total of 20 items with two subscales including positive affective subscale and negative affective subscale. A 4-point (1-4) scoring method is used. Higher scores represent higher levels of positive and negative affect
post-operative day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2019

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 21, 2021

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900682B0C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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