Objective: provide the simple, cheap and available solution to reduce anxiety in patients undergoing endoscopy and reduction of statistically significant in refusing to do (high stress).
Design: randomized, triple blind, single-center, one phase of clinical trial.
Study population: The inpatient and outpatient endoscopy candidates in Modarres hospital in saveh city.
The main criteria for inclusion: desire of participate for taking part in the study; having ordered endoscopy; lack of experience in educational courses (skills, problem solving, critical thinking, emotional intelligence, stress management techniques and yoga) in the last 6 months; not something new crisis like the death of first-degree relative; divorce in the past 6 months; no history of psychological problems or anxiety disorders diagnosed; having undergone previous endoscopy; no addiction drugs, alcohol; lack of sedation drugs consumption during the study.
Exclusion criteria: diagnosis of mental illness in person during the study; lack of cooperation necessary to complete a questionnaire; Dissuasion of participate in research.
Sample size: One hundred six, with risk of samples loss.
Intervention or interventions: the presence of family members at the bedside, during endoscopy and completed the questionair by all patients.
Intervention time: During endoscopy (and the individual patient's bedside).
The main outcome: to reduce fear and anxiety related to endoscopy and decrease significant statistics in relation to the refusal to do so.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017011931522N2
Registration date:2017-02-18, 1395/11/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-18, 1395/11/30
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Saveh University of Medical Science
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family members presence on anxiety of patients that candidates for endoscopy
Public title
The presence of family members in reducing anxiety of endoscopic procedure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness of participate; the ability to read and write; having ordered endoscopy; endoscopy appropriate diagnosis by a specialist; lack of educational experience in problem solving, critical thinking, emotional intelligence methods stress management and yoga in the past 6 months; not something new crisis like the death of first-degree relative; divorce in the past 6 months; no history of psychological problems or anxiety disorders diagnosed; having undergone previous endoscopy; no addiction drugs, alcohol; lack of sedation drugs consumption during the study.
Exclusion criteria: diagnosis of mental illness in person during the study; lack of cooperation necessary to complete a questionnaire; Dissuasion of participate in research
Age
From 19 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The first patient in the intervention group and randomly assigned one-to-one (one of) the control and intervention groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Saveh University of Medical Sciences
Street address
Saveh, SHariati st, Madar Sq, Saveh University of Medical Sciences
City
Saveh City
Postal code
3918698786
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.SAVEHUMS.REC139429
Health conditions studied
1
Description of health condition studied
Endoscopy
ICD-10 code
Y60.4, Y61
ICD-10 code description
During endoscopic examination
Primary outcomes
1
Description
The anxiety of endoscopy
Timepoint
The hidden anxiety questionaire (Two days after the intervention in two groups) / The revealed anxiety (Immediately During the endoscopy room and in the presence of a family members)
Method of measurement
State and Trait Anxiety Inventory (STAI)
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention Group1: The intervention group during endoscopy, one of the family members of the patient's presence in bedside and the patients immediately before endoscopy complete the spielberger anxiety questionnaire
Category
Prevention
2
Description
Control group: In the control group, the plain Spiel Berger anxiety questionnaire during the endoscopy after entrance to room and without the presence of family members of the patient's bedside is completed by the patients. The hidden Spiel Berger anxiety questionnaire two days after treatment is completed by two group's samples
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Endoscopy Unit of Moddares Hospital, Saveh University of Medical Sciences
Full name of responsible person
vahid naseri salahshour, MSc of Nursing Education (Medical - Surgical Field)