Determination The effect of provision of information by video and lecture before Extracorporeal Shock Wave Lithotripsy on patient anxiety and comfort
Design
clinical trial with a parallel group design of 122patients, Randomization by blocking method
Settings and conduct
This research is performed at Baharloo Hospital in Tehran First, the background and demographic information of the patients were collected and
Saliva samples taken and Physiological indicators including respiratory rate, pulse rate and blood pressure are collected before awareness and
Patients complete Spielberger Manifest Anxiety Questionnaire and Kolkaba General Comfort Questionnaire Then, in the intervention group, awareness is performed And again aliva samples taken and Physiological indicators collected and Patients complete Questionnaire.
The control group receives the information according to the previous routine of the ward.
Participants/Inclusion and exclusion criteria
Candidate patients for extracorporeal lithotripsy in Baharloo hospital with
Inclusion criteria
Any dissatisfaction with participating in the study
Intervention groups
To the intervention group in order to inform before the operation, in the morning of the operation Researcher With face-to-face speeches in groups of 3-4 in the conference room talks about Information included Introduction of urinary tract, how to create kidney stones and its types, symptoms, method of prevention, diagnosis and treatment, extracorporeal lithotripsy procedure, complications, care and postoperative follow-up and then play a video that shows Location, procedure, place of postoperative hospitalization This intervention takes 30 minutes Patients' questions are also answered for 30 minutes.
The control group receives the information according to the previous routine.
Main outcome variables
Possibility of reducing anxiety and increasing preoperative comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200827048546N1
Registration date:2020-09-06, 1399/06/16
Registration timing:prospective
Last update:2020-09-06, 1399/06/16
Update count:0
Registration date
2020-09-06, 1399/06/16
Registrant information
Name
saeedeh azizi mahkooyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3613 4292
Email address
saeedeh.azizi2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing The effect of provision of information by video and lecture before Extracorporeal Shock Wave Lithotripsy on patient anxiety and comfort
Public title
Assessing The effect of provision of information on patient anxiety and comfort in Extracorporeal Shock Wave Lithotripsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with urinary stone Disease and ESWL candidate
Willingness to cooperate in the project
Ages 18 to 65 years
The first experience of ESWL
Ability to read and write
No membership in the treatment team
Lack of vision and hearing problems
Do not take medications that reduce or increase cortisol like Corticosteroids, anticonvulsants, insulin
Do not use sedatives and anti-anxiety drugs before the intervention
Exclusion criteria:
Any patient dissatisfaction during the research
Any acute problems at the time of the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research is done in two stages.In the first step, the samples are selected by the Convenience Sampling method.
In the second stage, the allocation of samples to the two groups of intervention and control is done randomly and by blocking method;
The letter A is considered for the intervention group and the letter B for the control group.
Then we write all the combinations of the letters A, A,and B ,B, which are 6 different combinations, on 6 cards:
1. AABB
2. ABBA
3. ABAB
4. BAAB
5. BABA
6. BBAA
Then, from digits 1 to 6, a digit is randomly selected(
With the help of a table of random numbers or patient number one is asked to choose a card at random.)
For example, if the digit 2 is selected This means that the first person is in the intervention group and the next two people are in the control group and the fourth person is in the intervention group and This Process continues until the sample size reaches the quorum.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Nursing And Midwifery and Rehabilitation School, Tehran University Of Medical S
Street address
Tehran Province, Tehran, District 6, Nosrat St
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.088
Health conditions studied
1
Description of health condition studied
Urinary tract stones
ICD-10 code
N20.9
ICD-10 code description
Urinary calculus, unspecified
2
Description of health condition studied
Extracorporeal Shock Wave Lithotripsy
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
4
Description of health condition studied
Comfort
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Cortisol
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Physiological indicators
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Spielberger's anxiety questionnaire
Timepoint
Completion of the questionnaire before the intervention and after the awareness
Method of measurement
Spielberger Anxiety Questionnaire
2
Description
Measuring anxiety with salivary cortisol levels
Timepoint
Before the intervention and after the awareness
Method of measurement
Saliva sample in the amount of 3 to 5 cc
3
Description
Anxiety level by measuring the number of breaths, pulse rate and blood pressure
Timepoint
Before the intervention and after the awareness
Method of measurement
Count the number of breaths and pulses per minute And measuring blood pressure with a mercury sphygmomanometer
4
Description
Comfort score on the Kolkaba General Comfort Questionnaire
Timepoint
Before the intervention and after the awareness
Method of measurement
Kolkaba General Comfort Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To the intervention group in order to inform before the operation, in the morning of the operation Researcher With face-to-face speeches in groups of 3-4 in the conference room talks about Information included Introduction of urinary tract, how to create kidney stones and its types, symptoms, method of prevention, diagnosis and treatment, extracorporeal lithotripsy procedure, complications, care and postoperative follow-up and then play a video that shows Location, procedure, place of postoperative hospitalization This intervention takes 30 minutes Patients' questions are also answered for 30 minutes.
Category
Other
2
Description
Control group: The control group receives the information according to the previous routine.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Saeedeh Azizi Mahkooyeh
Street address
Tehran, Rahahan Square, Baharloo hospital
City
Tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Fax
+98 21 5564 8189
Email
baharloo@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojdeh Navidhamidi
Street address
Tehran Province, Tehran, District 6, Nosrat St
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Fax
+98 21 6642 7255
Email
fnm-researchdeputy@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?