Protocol summary
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Study aim
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Determination of the effect of reflection of mirrors (flat and convex) with and without adjustment phase on severity of pain due to needle insertion into the arterial fistula of the hemodialysis patients
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Design
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A Clinical trial with one group (before and after)
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Settings and conduct
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The study will be done in the hemodialysis unit of Mashhad montaseriye and Hefdah Shahrivar Hospital. 30 hemodialysis patients whose vascular access is through arterial venous fistula are selected according to the inclusion criteria by simple random sampling method.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Hemodialysis sessions three times a week; vascular access of arterial venous fistula; to be under hemodialysis through the current fistula for at least6 months; age range of 18-70; awareness of time, place and person; ability to speak and understand Persian
Exclusion criteria: fever of more than 37.5 degrees; oral or local intake of painkiller or sedation less than 6 hours before hemodialysis; use of psychoactive drugs 24 hours before hemodialysis; skin disorders at the injection site (ulcer, sensitivity, redness, secretion); problems with vision and myopia disturbances (30 cm or less)
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Intervention groups
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Each patient will be studied during 5 sessions. In the first session, as the control session, there is no intervention. During the next four sessions, one of two types of mirrors (flat and convex) will be used. Each mirror is used in 2 sessions.
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Main outcome variables
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pain
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:
IRCT20180412039277N1
Registration date:
2018-06-07, 1397/03/17
Registration timing:
registered_while_recruiting
Last update:
2018-12-31, 1397/10/10
Update count:
1
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Registration date
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2018-06-07, 1397/03/17
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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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2018-04-28, 1397/02/08
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Expected recruitment end date
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2018-06-19, 1397/03/29
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Actual recruitment start date
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2018-06-05, 1397/03/15
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Actual recruitment end date
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2018-08-14, 1397/05/23
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Trial completion date
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2018-08-14, 1397/05/23
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Scientific title
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The Effect of Various Mirror Reflection Visual Illusion on Pain Intensity due to Needle Insertion in Arterio-Venous Fistula Hemodialysis Patient's
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Public title
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The Effect of Mirror Reflection Visual Illusion on Pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having informed Consent to Participate in all Study Sessions
Hemodialysis Sessions should be three times a Week
Vascular Access to the Arterial Venous Fistula
Passing at least 6 Months from Hemodialysis via current Fistula
Being able to Speak and Understand Persian
Orientation to time, place and person
Exclusion criteria:
Visual Impairment and Disturbed Close Vision (30 cm or less)
Skin Disorders at the Injection Site (Wound, Sensitivity, Redness, Secretion)
using oral, topical or sedative drugs during 6 hours before Hemodialysis
using Psychoactive Drugs 24 hours before Hemodialysis
Fever Greater than 37.5 Celsius Degrees
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Age
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From 18 years old to 70 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:
15
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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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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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-07, 1397/01/18
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Ethics committee reference number
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IR.MUMS.REC.1397,9
Health conditions studied
1
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Description of health condition studied
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The pain caused by the insertion of fistula needles in hemodialysis patients
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ICD-10 code
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ICD-10 code description
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Primary outcomes
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Description
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Pain intensity
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Timepoint
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During the 5 sessions of hemodialysis (control and intervention sessions) immediately after the needle is inserted into the fistula
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Method of measurement
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Pain Visual Analogue Scale
Secondary outcomes
1
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Description
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The amount of visual illusion
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Timepoint
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During the 4 sessions of hemodialysis (intervention sessions), immediately after the needle is inserted into the fistula
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Method of measurement
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Longo Questionnaire
Intervention groups
1
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Description
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Control session (first sampling session): Needle entry to the fistula is performed by the nurse of the hemodialysis unit without any intervention. Intervention sessions (second and third sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put his both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, will be placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand will be in front of the mirror and the hand with the fistula will be behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror. Immediately, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit. Intervention sessions (fourth and fifth sampling sessions): The hospital bed's nightstand will be placed in front of the patient. We ask the patient to put both hands on the table. The mirror of that session, which has been randomly selected for that session in advance, is placed between the patient's hands at a distance of 30 cm from the forefinger of each hand, so that the healthy hand is in front of the mirror and the hand with the fistula is behind the mirror. We ask the patient to look at the picture of his healthy hand in the mirror for ten minutes. After ten minutes, the needle is inserted into the fistula of the hand behind the mirror by the nurse of the hemodialysis unit.
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Category
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N/A
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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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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I do not want to explain more
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available