Determination of the effect of nature audio-visual clip on anxiety level and physiologic parameters of patients referred for gastric endoscopy
Design
The intervention consists of a collection of Nature sounds and landscapes related to the sounds of Nature that are observed and listened to by a patient using a tablet and headphones for 5 minutes. The control group is seated on a chair for 5 minutes and receives routine care.
Settings and conduct
The study will be conducted at Kowsar Hospital affiliated to Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
The participants of this study are patients referred to Kowsar Hospital of Semnan for gastric endoscopy.Inclusion criteria included being over 30 years of age, minimum education at the end of elementary school, lack of hearing and vision problems, no previous endoscopy and no emergency endoscopy.
Intervention groups
Each of the intervention and control groups have 32 participants.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140721018550N7
Registration date:2019-10-11, 1398/07/19
Registration timing:prospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of audio-visual nature Clip on level of anxiety and physiologic parameters of patients under gastric endoscopy
Public title
The effect of nature Clip on level of anxiety and physiologic parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age of 30 years
Minimum elementary education
No deafness and no visual impairment
Lack of history of previous endoscopy
Lack of emergency endoscopy order
Exclusion criteria:
Patients' unwillingness to continue cooperation
Severe changes in the patient's physical condition
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
We first assign four subgroups (stratum): 1 - Women 30 to 45 years 2 - Men 30 to 45 years 3 - Women over 45 years 4 - Men over 45 years old. Each patient enrolled in the study is placed in one of these four groups. Then, using the randomized random list for each stratum (4 predefined lists), that person is in the intervention group A or control B. To create the desired list of 6 possible blocks, we assign quadrants to each numerical block (from I to VI): According to the random numbers table, numbers 1 through 6 correspond to the above blocks and do not count numbers 7 to 9 and 0. Random numbers are generated with Excel. Then the assignment list (from left to right) is determined for each stratum.
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 Semnan University of Medical Sciences
Street address
Nursing and Midwifery colledge, Semnan University of Medical Sciences, Kilometer5 Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.SEMUMS.REC.1398.113
Health conditions studied
1
Description of health condition studied
Gastric endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Immediately before the intervention and immediately after end of intervention
Method of measurement
6- item Spillberger inventory
Secondary outcomes
1
Description
ُSystolic and diastolic Blood pressure
Timepoint
Immediately before intervention and immediately after end of intervention
Method of measurement
Digital Sphygmomanometer
2
Description
Pulse rate
Timepoint
Immediately before intervention and immediately after end of intervention
Method of measurement
Digital Sphygmomanometer
Intervention groups
1
Description
Intervention group: َAt first,the demographic information questionnaire was completed and then anxiety measured by a six-item Spielberger inventory by the subjects and their physiological parameters (blood pressure and pulse rate) were measured and recorded in a sitting position with the same digital device. Then audio - video clip of nature music including sea, birds and forest sound was played for 5 minutes via tablet connected to headphones and immediately afterwards, Spielberger anxiety questionnaire and their physiological parameters (blood pressure and pulse rate) will be measured and recorded in sitting position.
Category
Other
2
Description
Control group:At first,the demographic information questionnaire was completed and then anxiety measured by a six-item Spielberger inventory by the subjects and their physiological parameters (blood pressure and pulse rate) were measured and recorded in a sitting position with the same digital device. Then control group receive routine care in a sitting position equivalent to intervention time in intervention group and immediately afterwards, Spielberger anxiety questionnaire and their physiological parameters (blood pressure and pulse rate) will be measured and recorded in sitting position.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital,Semnan
Full name of responsible person
ِDr.Mohammad Memarian
Street address
Iran,Semnan, Amin Bolevard, Kosar hospital
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3104 3200
Fax
+98 23 3343 7837
Email
draria2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz kokhaei
Street address
Semnan -Semnan University of Medical Sciences- Deputy Minister for Research and Technology
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
kokhaei@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Faculty memeber(Assisstant professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Faculty member(Assisstant professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th Kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nr_dana@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
ّFaculty memeber(Assisstant professor)
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nr_dana@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available