Protocol summary

Study aim
Determining the effects of sound frequencies on pain, comfort, anxiety level and hemodynamic changes in the processes of venous-arterial blood sampling, intramuscular injection and intravenous access.
Design
This clinical trial study was conducted on 300 patients with control and intervention (parallel) groups in a randomized and double-blind manner and in phase 3. The software was used for randomization.
Settings and conduct
Patients referred to Imam Reza and Imam Khomeini Hospital in Kermanshah who needed blood sampling and intramuscular injection. Patients were randomly divided into intervention and control groups. Only in the intervention groups, sound frequency stimulation is performed by headphones on the ear for patients at the same time as the needle tip is inserted. In order to conduct a double-blind study, the patients and the colleague recording the results were not aware of the grouping and type of intervention.
Participants/Inclusion and exclusion criteria
Patients requiring blood sampling and intramuscular injection who experience acute pain.
Intervention groups
In a control group; during each of the procedures, the patients do not receive any stimulus or pain relief, and the procedure is performed according to the routine of the department and the noise level of the environment. In another control group; during each of the procedures, passive wireless headphones are placed on both ears of the patients so that the intensity of the ambient sound is less than 5 dB, and the patients in this group do not receive any sound stimuli. In intervention groups, sound stimulation with frequencies of 5, 10, 15, 20, 30, 40, 50 ,100Hz: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with different frequencies is performed from one minute before the procedure until its completion.
Main outcome variables
pain; stress; comfort

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240123060780N2
Registration date: 2024-02-19, 1402/11/30
Registration timing: prospective

Last update: 2024-02-19, 1402/11/30
Update count: 0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Rasoul Kavyannejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4618
Email address
r.kavyannejad@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2025-04-14, 1404/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating effects of sound frequencies on pain, comfort and anxiety levels in venous-arterial blood sampling, intramuscular injection, and venous intra-vascular access process
Public title
Effect of sound frequencies on pain level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness Literacy, reading, writing Verbal ability and healthy vision The skin of the study area should be healthy No peripheral edema in the intervention area .
Exclusion criteria:
Addiction Taking sedatives and anesthetic during the last 24 hours Having a pacemaker and implantable cardiac device and defibrillators History of diabetes Patient restlessness
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the samples in this study is done by computer software. By the software, a random sequence of letters A, B, C, D, E, F, G, H, I, G is assigned to the intervention and control groups. . In the output of the software, blocks are created with a sequence of 8 and 10 random letters (each letter is considered for a group). Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally, according to the sequence of letters, the patient is placed in one of the intervention or control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In control group 1; Headphones are placed on the patient's ear. But the headphones have no function, and the patient is able to hear the surrounding sounds naturally through the holes made on the ear part of the headphones. In control group 2; Healthy headphones but without sound function are placed on the patient's ear so that he cannot hear the surrounding sounds. In the intervention groups; Healthy headphones with sound function with a specific frequency are used. Due to the identical appearance of the interventions and the patient's lack of information about the grouping and type of stimulation intervention frequency, the patients were blinded to the intervention. Blood sampling and intramuscular injections are done by the co-colleague. Audio frequency was applied through headphones and audio frequency settings were done through Bluetooth headphones. The other colleague who registers the variables does not know how to group and the type of frequency received by the patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.KUMS.REC.1402.634

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
Pain
Timepoint
The pain level is measured immediately after the procedure and also in 1, 3 and 5 minutes after the procedure is completed.
Method of measurement
The visual analog scale

2

Description
Comfort level
Timepoint
It is measured in 5 minutes after each procedure (injection or blood sampling).
Method of measurement
The visual analog scale

3

Description
Stress level
Timepoint
5 minutes after each procedure
Method of measurement
The visual analog scale

Secondary outcomes

1

Description
Heart rate
Timepoint
The hear rate is measured before and after procedure (injection and blood sampling) and also in 1, 3 and 5 minutes after the procedure is completed.
Method of measurement
Using portable pulse oximetry

Intervention groups

1

Description
Control group: during each of the procedures, the patients do not receive any stimulation or analgesia, and the procedure is performed according to the routine of the department and the noise level of the environment.
Category
Placebo

2

Description
Control group: during each of the procedures, passive wireless headphones are placed on both ears of the patients so that the intensity of the ambient sound is less than 5 dB, and the patients in this group do not receive any sound stimuli.
Category
Placebo

3

Description
Intervention group: 5 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 5 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

4

Description
Intervention group: 10 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 10 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

5

Description
Intervention group: 15 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 15 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

6

Description
Intervention group: 20 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 20 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

7

Description
Intervention group: 30 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 30 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

8

Description
Intervention group: 40 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 40 Hz is performed from one minute before the procedure until its completion
Category
Treatment - Devices

9

Description
Intervention group: 50 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 50 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

10

Description
Intervention group: 100 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 100 Hz is performed from one minute before the procedure until its completion.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
said mohamadi
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6300
Email
dr.saidmohamadi@gmail.com

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Said mohamadi
Street address
Imam Khomeini ,Naghlye street, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3728 3602
Email
dr.saidmohamadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 6835
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Said mohamadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
dr.saidmohamadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Said mohamadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
dr.saidmohamadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Kavyannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 4618
Fax
Email
r.kavyannejad@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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