Protocol summary
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Study aim
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The aim of this study was to determine the effect of mental imagery on anxiety in patients before abdominal surgery.
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Design
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This clinical trial study was conducted with parallel group, randomized design.
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Settings and conduct
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In this randomized clinical trial, 116 patients undergoing appendectomy and herniorrhaphy at Sabzevar Beheshti Hospital in 2014 will be randomly assigned to intervention and control groups.
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Participants/Inclusion and exclusion criteria
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Some of inclusion criteria included: patients 15 to 49 years old; abdominal surgery (appendicitis and hernia requiring surgical intervention); having full consciousness
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Intervention groups
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Intervention group: 18-minute mental imagery CD will be played through headphones, which include visualization of the beautiful scenery and pleasant (the beach) and positively associated with increased wellness is empathy. The control group received routine care.
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Main outcome variables
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anxiety
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:
IRCT2013122315905N1
Registration date:
2014-05-27, 1393/03/06
Registration timing:
retrospective
Last update:
2019-06-10, 1398/03/20
Update count:
1
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Registration date
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2014-05-27, 1393/03/06
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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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Sabzevar University of Medical Sciences
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Expected recruitment start date
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2013-11-22, 1392/09/01
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Expected recruitment end date
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2014-03-19, 1392/12/28
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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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The Effect of Mental Imagery on Preoperative Anxiety in Patients Undergoing Abdominal Surgery
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Public title
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The Effect of Mental Imagery on Anxiety
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients 15 to 49 years old
abdominal surgery (appendicitis and hernia requiring surgical intervention)
having full consciousness
loss of hearing
loss of hearing; having a stressful event (divorce, death of spouse or close relative, loss of a job, migration, severe accident) during the last 6 months
Exclusion criteria:
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Age
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From 15 years old to 49 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:
116
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment using random blocks
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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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Parallel
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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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2013-11-13, 1392/08/22
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Ethics committee reference number
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medsab.Rec.92.1
Health conditions studied
1
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Description of health condition studied
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Anxiety before abdominal surgery
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
Primary outcomes
1
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Description
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Preoperative Anxiety
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Timepoint
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Before surgery
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Method of measurement
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Spielberger Anxiety Inventory
Intervention groups
1
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Description
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In addition to routine care, interventional group listened to guided imagery audio CD, one hour before surgery for 18 minutes.
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Category
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Other
2
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Description
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Control group received only routine care.
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Category
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Treatment - 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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Sabzevar 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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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