The aim of this study is to determine the effect of nature-based sounds on the level of anxiety and satisfaction of patient before undergoing gastrointestinal endoscopy.
This quasi- experimental study will be conducted in Mostafa Khomeini hospital in Tehran, Iran with the participation of 124 patients who are scheduled to undergo upper gastrointestinal endoscopy.
The patients are randomly allocated to the experiment and control groups (60 patients per each group).
Random allocation will be conducted by using the randomization list. The patients in the experiment group will receive the intervention of nature- based sounds such as birds’ song, soothing rain sounds, and river stream using an audiotape via fixed earphones. The intervention will be conducted in a quiet room that will last for 15 minutes, between 25 - 50 decibel (dB) before the procedure , while the control group will wear the foam-lined headphone
without sounds for a similar time frame as the intervention group.
The level of anxiety (measured by using spielburger questionnaire) and vital signs (recorded in a checklist) are used in both groups before the intervention, before the endoscopy (immediately before the procedure) and after endoscopy. Finally, the level of satisfaction of patients is measured by using the visual analogue scale after endoscopy.
The researchers and data monitoring committee will not become aware of what sort of intervention the patients receive.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304137529N4
Registration date:2014-01-25, 1392/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-25, 1392/11/05
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research , Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way,Tehran, Iran.
Expected recruitment start date
2013-04-15, 1392/01/26
Expected recruitment end date
2014-03-17, 1392/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of implementing nature based sounds with placebo on anxiety patients undergoing gastrointestinal endoscopy
Public title
Effect of nature-based sounds on the level of anxiety and satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having the order of upper gastrointestinal endoscopy at least one day before the procedure; age over 18 years old; ability to speak and understand Persian language;
having no visual and hearing disorders;
Having no previous history of endoscopy;
Having no order of emergency endoscopy;
Having no history of psychological diseases or anxiety disorders;
no consuming opium or sedative drugs;
not experiencing severe pain due to nature of disease;
not receiving hypertension or anti hypertensive drugs.
Exclusion criteria: Cancellation of endoscopy due to any reason except patient’s anxiety; Not willingness to participate in this study
Age
From 60 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express
City
Tehran
Postal code
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
41/166426
Health conditions studied
1
Description of health condition studied
Upper Gastrointestinal Endoscopy
ICD-10 code
K20, K31
ICD-10 code description
Diseases of Oesophagus, Stomach and Duodenum
Primary outcomes
1
Description
Anxiety
Timepoint
Before nature-based sounds therapy , before endoscopy , and after endoscopy
Method of measurement
Spielberger questionnaire
2
Description
Blood pressure
Timepoint
Before nature-based sounds therapy , before endoscopy , and after endoscopy
Method of measurement
Sphygmomanometer
3
Description
Respiratory rate
Timepoint
Before nature-based sounds therapy , before endoscopy , and after endoscopy
Method of measurement
Checklist
4
Description
Pulse rate
Timepoint
before nature based sounds therapy , before endoscopy , and after endoscopy
Method of measurement
Checklist
5
Description
Patient's satisfaction
Timepoint
After endoscopy
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the control group, except for listening to nature-based sounds, all routine activities will be performed before endoscopy
Category
Other
2
Description
The patients are randomly allocated to the experiment and control groups (60 patients per each group).
Random allocation will be conducted by using the randomization list. The patients in the experiment group will receive the intervention of nature- based sounds such as birds’ song, soothing rain sounds, and river stream using an audiotape via fixed earphones. The intervention will be conducted in a quiet room that will last for 15 minutes, between 25 - 50 decibel (dB) before the procedure , while the control group will wear the foam-lined headphone without sounds for a similar time frame as the intervention group.
The level of anxiety (measured by using spielburger questionnaire) and vital signs (recorded in a checklist) are used in both groups before the intervention, before the endoscopy (immediately before the procedure) and after endoscopy.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endoscopy Unit in Mostafa Khomeini Hospital, Tehran, Iran.
Full name of responsible person
Ms. Ali Mohammadi
Street address
Mostafa Khomeini Hospital , Italia Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Shahed University Vice chancellor for research : Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way ,Shahed University Vice chancellor for research : Dr. Zahra Kiasalari
City
Tehran
Postal code
15917153140
Phone
+98 21 6641 8592
Fax
+98 21 6641 8580
Email
reje@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing Faculty, No.3, Rahimzadeh Street , Valie Asre Street
City
Tehran
Postal code
15917153140
Phone
+98 21 51210
Fax
+98 21 6641 8580
Email
reje@shahed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Ph.D
Other areas of specialty/work
Street address
Nursing Faculty, No.3, Rahimzadeh Street , Valie Asre Street
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8592
Fax
+98 21 6641 8580
Email
reje@shahed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)