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Completed

NCT Number: NCT04971057

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematuria Hemorrhage Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimedia information program of renal biopsy

Other

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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

The Effects of Multimedia Information for Patients With Renal Biopsy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2021
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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