Multimedia Information for Patients With Renal Biopsy
Primary Purpose
Pain, Anxiety, Hematuria
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
multimedia information program of renal biopsy
Sponsored by
About this trial
This is an interventional health services research trial for Pain focused on measuring multimedia information, renal biopsy, self-efficacy, pain, anxiety, positive and negative affective, hematuria
Eligibility Criteria
Inclusion Criteria:
- patients are at least 20 years old
- patients need to undergo a renal biopsy
- patients can communicate in Chinese or Taiwanese
- patients agree to participate in the research and sign the consent form
- patients have family members accompanying
Exclusion Criteria:
- patients have undergone renal biopsy before
- patients have history of mental disorder
- patients use anticoagulants
Sites / Locations
- Chang Gung Memorial Hospital at Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Multimedia information Group
Arm Description
The control group received routine care
The experimental group received a multimedia information
Outcomes
Primary Outcome Measures
General Self-Efficacy Scale
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
General Self-Efficacy Scale
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Pain Visual Analogy Scale
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
Pain Visual Analogy Scale
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.
Pain Visual Analogy Scale
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.
Pain Visual Analogy Scale
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.
Visual Analogue Scale for Anxiety
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
Visual Analogue Scale for Anxiety
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
Visual Analogue Scale for Anxiety
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
Visual Analogue Scale for Anxiety
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
Positive and Negative Affective Scale
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
Positive and Negative Affective Scale
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
Full Information
NCT ID
NCT04971057
First Posted
July 12, 2021
Last Updated
August 3, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04971057
Brief Title
Multimedia Information for Patients With Renal Biopsy
Official Title
The Effects of Multimedia Information for Patients With Renal Biopsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2019 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Hematuria
Keywords
multimedia information, renal biopsy, self-efficacy, pain, anxiety, positive and negative affective, hematuria
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received routine care
Arm Title
Multimedia information Group
Arm Type
Experimental
Arm Description
The experimental group received a multimedia information
Intervention Type
Other
Intervention Name(s)
multimedia information program of renal biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
General Self-Efficacy Scale
Description
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Time Frame
pretest
Title
General Self-Efficacy Scale
Description
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Time Frame
post-operative day 9
Title
Pain Visual Analogy Scale
Description
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
Time Frame
pretest
Title
Pain Visual Analogy Scale
Description
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.
Time Frame
pre-operation
Title
Pain Visual Analogy Scale
Description
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.
Time Frame
post-operative day 1
Title
Pain Visual Analogy Scale
Description
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.
Time Frame
post-operative day 9
Title
Visual Analogue Scale for Anxiety
Description
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
Time Frame
pretest
Title
Visual Analogue Scale for Anxiety
Description
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
Time Frame
pre-operation
Title
Visual Analogue Scale for Anxiety
Description
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
Time Frame
post-operative day 1
Title
Visual Analogue Scale for Anxiety
Description
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
Time Frame
post-operative day 9
Secondary Outcome Measure Information:
Title
Positive and Negative Affective Scale
Description
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
Time Frame
pretest
Title
Positive and Negative Affective Scale
Description
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
Time Frame
post-operative day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients are at least 20 years old
patients need to undergo a renal biopsy
patients can communicate in Chinese or Taiwanese
patients agree to participate in the research and sign the consent form
patients have family members accompanying
Exclusion Criteria:
patients have undergone renal biopsy before
patients have history of mental disorder
patients use anticoagulants
Facility Information:
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32489494
Citation
Akca A, Yilmaz G, Esmer AC, Yuksel S, Koroglu N, Cetin BA. Use of video-based multimedia information to reduce anxiety before office hysteroscopy. Wideochir Inne Tech Maloinwazyjne. 2020 Jun;15(2):329-336. doi: 10.5114/wiitm.2019.89378. Epub 2019 Oct 28.
Results Reference
background
PubMed Identifier
24812709
Citation
Batuyong ED, Jowett AJ, Wickramasinghe N, Beischer AD. Using multimedia to enhance the consent process for bunion correction surgery. ANZ J Surg. 2014 Apr;84(4):249-54. doi: 10.1111/ans.12534.
Results Reference
background
PubMed Identifier
26464072
Citation
Bowers N, Eisenberg E, Montbriand J, Jaskolka J, Roche-Nagle G. Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures. Surgeon. 2017 Feb;15(1):7-11. doi: 10.1016/j.surge.2015.09.001. Epub 2015 Oct 14.
Results Reference
background
PubMed Identifier
25374824
Citation
Brachemi S, Bollee G. Renal biopsy practice: What is the gold standard? World J Nephrol. 2014 Nov 6;3(4):287-94. doi: 10.5527/wjn.v3.i4.287.
Results Reference
background
PubMed Identifier
24957046
Citation
Chung S, Koh ES, Kim SJ, Yoon HE, Park CW, Chang YS, Shin SJ. Safety and tissue yield for percutaneous native kidney biopsy according to practitioner and ultrasound technique. BMC Nephrol. 2014 Jun 23;15:96. doi: 10.1186/1471-2369-15-96.
Results Reference
background
PubMed Identifier
26856480
Citation
Demircelik MB, Cakmak M, Nazli Y, Sentepe E, Yigit D, Keklik M, Arslan M, Cetin M, Eryonucu B. Effects of multimedia nursing education on disease-related depression and anxiety in patients staying in a coronary intensive care unit. Appl Nurs Res. 2016 Feb;29:5-8. doi: 10.1016/j.apnr.2015.03.014. Epub 2015 Apr 7.
Results Reference
background
PubMed Identifier
26777257
Citation
D'Souza V, Blouin E, Zeitouni A, Muller K, Allison PJ. Multimedia information intervention and its benefits in partners of the head and neck cancer patients. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12440. Epub 2016 Jan 18.
Results Reference
background
PubMed Identifier
24462856
Citation
Ellett L, Villegas R, Beischer A, Ong N, Maher P. Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):602-11. doi: 10.1016/j.jmig.2014.01.002. Epub 2014 Jan 23.
Results Reference
background
PubMed Identifier
28352011
Citation
El-Reshaid K, El-Reshaid W, Al-Bader D, Varro J, Madda J, Sallam HT. Biopsy of small kidneys: A safe and a useful guide to potentially treatable kidney disease. Saudi J Kidney Dis Transpl. 2017 Mar-Apr;28(2):298-306. doi: 10.4103/1319-2442.202767.
Results Reference
background
PubMed Identifier
26379073
Citation
Hirsch JK, Sirois FM, Molnar D, Chang EC. Pain and Depressive Symptoms in Primary Care: Moderating Role of Positive and Negative Affect. Clin J Pain. 2016 Jul;32(7):562-7. doi: 10.1097/AJP.0000000000000292.
Results Reference
background
PubMed Identifier
26551213
Citation
Hsueh FC, Chen CM, Sun CA, Chou YC, Hsiao SM, Yang T. A Study on the Effects of a Health Education Intervention on Anxiety and Pain During Colonoscopy Procedures. J Nurs Res. 2016 Jun;24(2):181-9. doi: 10.1097/jnr.0000000000000112.
Results Reference
background
PubMed Identifier
27631225
Citation
Hu T, Liu Q, Xu Q, Liu H, Feng Y, Qiu W, Huang F, Lv Y. Absorption fever characteristics due to percutaneous renal biopsy-related hematoma. Medicine (Baltimore). 2016 Sep;95(37):e4754. doi: 10.1097/MD.0000000000004754.
Results Reference
background
PubMed Identifier
30825408
Citation
Karadag E. The effect of a self-management program on hand-washing/mask-wearing behaviours and self-efficacy level in peritoneal dialysis patients: a pilot study. J Ren Care. 2019 Jun;45(2):93-101. doi: 10.1111/jorc.12270. Epub 2019 Mar 2.
Results Reference
background
PubMed Identifier
27456461
Citation
Kauric-Klein Z, Peters RM, Yarandi HN. Self-Efficacy and Blood Pressure Self-Care Behaviors in Patients on Chronic Hemodialysis. West J Nurs Res. 2017 Jul;39(7):886-905. doi: 10.1177/0193945916661322. Epub 2016 Jul 24.
Results Reference
background
PubMed Identifier
25394450
Citation
Mohammed A, Manjanabil P, deTakats D. Retroperitoneum: a forgotten and fatal aspect of kidney biopsy. Saudi J Kidney Dis Transpl. 2014 Nov;25(6):1278-81. doi: 10.4103/1319-2442.144267.
Results Reference
background
Learn more about this trial
Multimedia Information for Patients With Renal Biopsy
We'll reach out to this number within 24 hrs