Multimedia Information for Patients With Renal Biopsy

• Sponsor: National Taipei University of Nursing and Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04971057
• Collaborator: Chang Gung Memorial Hospital (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Anxiety; Hematuria	Other: multimedia information program of renal biopsy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Health Services Research
• Official Title: The Effects of Multimedia Information for Patients With Renal Biopsy
• Actual Study Start Date: Dec 14, 2019
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. General Self-Efficacy Scale [pretest]

   A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy

2. General Self-Efficacy Scale [post-operative day 9]

   A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy

3. Pain Visual Analogy Scale [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

4. Pain Visual Analogy Scale [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.

5. Pain Visual Analogy Scale [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.

6. Pain Visual Analogy Scale [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.

7. Visual Analogue Scale for Anxiety [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

8. Visual Analogue Scale for Anxiety [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

9. Visual Analogue Scale for Anxiety [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

10. Visual Analogue Scale for Anxiety [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

Secondary Outcome Measures

1. Positive and Negative Affective Scale [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

2. Positive and Negative Affective Scale [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital at Linkou	Taoyuan		Taiwan

Sponsors and Collaborators

• National Taipei University of Nursing and Health Sciences
• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ching-Hui Chien, Associate Professor, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT04971057
• Other Study ID Numbers: 201900682B0C
• First Posted: Jul 21, 2021
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 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
• Keywords provided by Ching-Hui Chien, Associate Professor, National Taipei University of Nursing and Health Sciences: multimedia information; renal biopsy; self-efficacy; pain; anxiety; positive and negative affective; hematuria
• Additional relevant MeSH terms: Hematuria

Study Results

No Results Posted as of Jul 28, 2021