Protocol summary
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Study aim
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Determining the Effect of Virtual Reality and Guided Imaging Technique on the Pain Caused by the Injection of Catheter in Hemodialysis Patients
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Design
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The clinical trial includes a group that initially receives intervention 1 (guided visualization technique) and then intervention 2 (virtual reality). The sample size is 60 people without randomization. The trial phase does not apply to this study.
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Settings and conduct
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This study will be carried out at Bhlul Hospital in Gonabad. The diversion of thought is guided by the technique of visualization and virtual reality technology, and its effect on the pain caused by cannulation will be measured.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Age of 18-60; Awareness of time, place and persons at the time of data collection; Minimal reading and writing skills
No entry Criteria: Lack of Diabetic neuropathy; history of mental illness; continues use of analgesics 24 hours before hemodialysis; damaged skin in the intended position; ; use of alcohol and drugs
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Intervention groups
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Intervention 1: Distraction with the guided visualization technique in two intermittent dialysis sessions
Intervention 2: Deviation of thought with virtual reality technology in two intermittent dialysis sessions
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Main outcome variables
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Pain intensity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171219037966N3
Registration date:
2018-06-13, 1397/03/23
Registration timing:
retrospective
Last update:
2018-09-06, 1397/06/15
Update count:
2
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Registration date
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2018-06-13, 1397/03/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-13, 1396/12/22
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Expected recruitment end date
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2018-06-10, 1397/03/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the effect of Distraction on two methods of virtual reality and guided visualization on pain caused by venous cannulation in hemodialysis patients
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Public title
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Comparison of the effect of two virtual reality methods and guided visualization on intravenous cannulation pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 60 years
Awareness of time, place and persons at the time of data collection
Minimal the reading and writing skills
Exclusion criteria:
history of mental illness
diabetic neuropathy
patient unwillingness to continue the study
continues use of analgesics 24 hours before hemodialysis
usevof alcohol and drugs
damaged skin in the intended position
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Due to intervention and outcome evaluation, the researcher, investigator and analyst assistant does not know the type of intervention performed during the sessions.
Ethics committees
1
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Ethics committee
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Approval date
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2018-03-12, 1396/12/21
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Ethics committee reference number
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IR.GMU.REC.1396.163
Health conditions studied
1
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Description of health condition studied
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chronic renal failure
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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pain
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Timepoint
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The beginning of the study; the first intervention session and 2, 9 and 11 days after the first intervention
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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Intervention group number 1: After receiving informed consent from the patient, the demographic questionnaire is filled in half an hour before the intervention. Then, 25 minutes before hemodialysis, the patients are in supine position, then a few deep abdominal cavities and a diaphragm with closed eyes and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low-light room, walking limits) into an audio file and focusing on the visualization of an illustration, a desirable scenario of listening to the stage-by-stage relaxation of the limbs will be listened without any muscle movement. Audio file The content of mental imagery is played back for 20 minutes, taking into account the sound level between 21 and 10 dB (calibrated by the audiometric expert) so that the person who narrates the text's speaker in the visualization state of the image is in the desired desirable landscape. Then the data will be collected by the researcher's assistant when the file passes for 15 minutes (5 minutes to complete the audio). During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
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Category
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Other
2
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Description
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Intervention group number 2: In the virtual reality group, 10 minutes before the dialysis, special glasses are placed on the head of the patient and they spend 20 minutes spelling pictures designed to reduce pain. After 15 minutes of playing the file, during the watch, the fistula placement and the pain score will be measured by the researcher's assistant. During cannulation, the patient determines the intensity of his pain by marking a 10-cm line. The assistant researcher measures and records the distance between the zero point and the location of the sign.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gonabad University of Medical Sciences
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Proportion provided by this source
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30
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available