NCT04971057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

July 12, 2021

Last Update Submit

August 3, 2023

Conditions

Keywords

multimedia informationrenal biopsyself-efficacypainanxietypositive and negative affectivehematuria

Outcome Measures

Primary Outcomes (10)

  • General Self-Efficacy Scale

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Positive and Negative Affective Scale

    pretest

  • Positive and Negative Affective Scale

    post-operative day 9

Study Arms (2)

Control Group

NO INTERVENTION

The control group received routine care

Multimedia information Group

EXPERIMENTAL

The experimental group received a multimedia information

Other: multimedia information program of renal biopsy

Interventions

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.

Multimedia information Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients have undergone renal biopsy before
  • patients have history of mental disorder
  • patients use anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital at Linkou

Taoyuan District, Taiwan

Location

Related Publications (15)

  • 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.

    PMID: 32489494BACKGROUND
  • 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.

    PMID: 24812709BACKGROUND
  • 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.

    PMID: 26464072BACKGROUND
  • 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.

    PMID: 25374824BACKGROUND
  • 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.

    PMID: 24957046BACKGROUND
  • 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.

    PMID: 26856480BACKGROUND
  • 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.

    PMID: 26777257BACKGROUND
  • 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.

    PMID: 24462856BACKGROUND
  • 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.

    PMID: 28352011BACKGROUND
  • 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.

    PMID: 26379073BACKGROUND
  • 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.

    PMID: 26551213BACKGROUND
  • 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.

    PMID: 27631225BACKGROUND
  • 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.

    PMID: 30825408BACKGROUND
  • 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.

    PMID: 27456461BACKGROUND
  • 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.

    PMID: 25394450BACKGROUND

MeSH Terms

Conditions

PainAnxiety DisordersHematuria

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 21, 2021

Study Start

December 14, 2019

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations