PainNCT04971057

Multimedia Information for Patients With Renal Biopsy

A study testing multimedia information program of renal biopsy in people with Pain and Anxiety, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Pain, Anxiety, Hematuria
What is being tested?: multimedia information program of renal biopsy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteTaiwan
Study dates: 14 Dec 2019to 5 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chang Gung Memorial Hospital at Linkou
Taoyuan

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions: Pain, Anxiety, Hematuria
Being tested: multimedia information program of renal biopsy
Keywords: multimedia information, renal biopsy, self-efficacy, pain, anxiety, positive and negative affective, hematuria
Medical subject headings: Pain, Anxiety Disorders, Hematuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

multimedia information program of renal biopsyOther
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.

Study groups in NCT04971057
Study group	Role	What they receive
Control Group	No intervention	The control group received routine care
Multimedia information Group	Experimental	The experimental group received a multimedia information Receives: Other: multimedia information program of renal biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

General Self-Efficacy Scale
A total of 10 items. A 4-point(1-4) scoring method was adopted. Higher scores indicate higher self-efficacy
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: post-operative day 9

Secondary outcomes (2)

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
Measured: pretest
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
Measured: post-operative day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20195 Jan 2021

First posted21 Jul 2021
Study start14 Dec 2019
Primary completion5 Jan 2021
Study completion5 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04971057
Sponsor's protocol ID: 201900682B0C
Status last verified: Aug 2023
First submitted: 12 Jul 2021
Last updated: 7 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32489494
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.
PubMed 24812709
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.
PubMed 26464072
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.
PubMed 25374824
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.
PubMed 24957046
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.
PubMed 26856480
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.
PubMed 26777257
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.
PubMed 24462856
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.
PubMed 28352011
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.
PubMed 26379073
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.
PubMed 26551213
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.
PubMed 27631225
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.
PubMed 30825408
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.
PubMed 27456461
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.
PubMed 25394450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Multimedia Information for Patients With Renal Biopsy
ClinicalTrials.gov ID: NCT04971057
Acronym / sponsor ID: 201900682B0C
Conditions: Pain, Anxiety, Hematuria
Keywords: multimedia information, renal biopsy, self-efficacy, pain, anxiety, positive and negative affective, hematuria
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: National Taipei University of Nursing and Health SciencesUniversity, hospital or other
Collaborators: Chang Gung Memorial Hospital
Study start: 14 Dec 2019 (actual)
Primary completion: 5 Jan 2021 (actual)
Study completion: 5 Jan 2021 (actual)
First posted: 21 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Control Group	No intervention	–The control group received routine care
Multimedia information Group	Experimental	Other: multimedia information program of renal biopsyThe experimental group received a multimedia information

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
multimedia information program of renal biopsyMultimedia 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.	Other	Multimedia information Group

Primary outcome

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
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
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
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.
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.
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.
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
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
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
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

2 secondary outcomes

Positive and Negative Affective Scale
Time frame: pretest
Positive and Negative Affective Scale
Time frame: post-operative day 9

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Background: PubMed 32489494Akca 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.
Background: PubMed 24812709Batuyong 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.
Background: PubMed 26464072Bowers 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.
Background: PubMed 25374824Brachemi 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.
Background: PubMed 24957046Chung 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.
Background: PubMed 26856480Demircelik 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.
Background: PubMed 26777257D'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.
Background: PubMed 24462856Ellett 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.
Background: PubMed 28352011El-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.
Background: PubMed 26379073Hirsch 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.
Background: PubMed 26551213Hsueh 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.
Background: PubMed 27631225Hu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing multimedia information program of renal biopsy in people with Pain and Anxiety, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Self-Efficacy Scale (time frame: pretest). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04971057, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.