Comparison of the effect of rhythmic breathing with subjective imaging on pain intensity during spinal needle insertion in patients undergoing spinal anesthesia
Comparison of the effect of rhythmic breathing with subjective imaging on pain during spinal needle insertion in patients undergoing spinal anesthesia
Design
The present study is a three-group clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3on 120 patients. In this study, R software will be used for randomization.
Settings and conduct
This study will be performed in the operating room of Bu Ali Sina Hospital in Hamadan. Patients who are candidates for surgery and the use of spinal anesthesia will be selected for this study. The spinal anesthesia technique is performed by a skilled anesthesiologist and the measurement of pain is recorded by the researcher based on the patients' statements.
Participants/Inclusion and exclusion criteria
- Age between 18 and 75
- No anatomical abnormalities in the lumbar region
- Do not use painkillers
- Do not use opium
Intervention groups
Patients are randomly divided into three groups: control, rhythmic breathing and mental imagery.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210828052307N1
Registration date:2021-09-19, 1400/06/28
Registration timing:prospective
Last update:2021-09-19, 1400/06/28
Update count:0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Elham Shakibanezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 8899
Email address
elhamshakiba09@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rhythmic breathing with subjective imaging on pain intensity during spinal needle insertion in patients undergoing spinal anesthesia
Public title
Comparison of the effect of rhythmic breathing with subjective imaging on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate verbally
No specific disease
No anatomical problems in the lumbar area and skin
No neurological disorders, plagia and paresis in the area of the lower thoracic vertebrae
Exclusion criteria:
Need to try to insert the needle more than once
Lack of patient cooperation during spinal needle insertion
Use of other methods to reduce pain
Use of sedatives and hypnotics
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to one of three groups in order of entry. In order to be randomized, sixth blocks (ABABCC-ACABBC-BAACCB-ACCBAB-CBCABA-AABBCC - CCBAAB-CABABC-BCABCA, etc.) will be prepared according to the number of participants and placed in envelopes. Then, when the patients enter the study, one of the envelopes is removed from the bag by one of the nurses who has no role in the study and is sampled without permutation.
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 Hamadan University of Medical Sciences
Street address
Hamadan, Shariati Crossroads, Ayatollah Kashani Blvd., Hamadan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.UMSHA.REC.1400.351
Health conditions studied
1
Description of health condition studied
Pain when inserting a spinal needle
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain when inserting a spinal needle
Timepoint
Pain will be measured immediately after spinal anesthesia.
Method of measurement
using a Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In first intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the rhythmic breathing group, patients are asked to perform rhythmic breathing before inserting a spinal needle as follows: close their eyes and do a deep, long breath through the nose with three numbers, then breathe in the lungs. Hold and count to 3, and then exhale slowly through the mouth with 3 numbers.
Category
Other
2
Description
In second intervention group, patients are given training individually by the researcher on the morning of the operation and in the surgery ward. In the mental imaging group, after the patients are placed on the operating table just before and during the insertion of the spinal needle, a sea sound is played to the patient by a headphone and he is asked to visualize the images in his mind at the same time.
Category
Prevention
3
Description
Control group: The patient is placed on a surgical bed, spinal anesthesia is performed by an anesthesiologist, and one minute after the procedure and the patient's hemodynamic status is confirmed, the patient is ask to indicate the severity of pain when the needle was inserted. .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Hospital
Full name of responsible person
Dr. Mohammad Mohsen Yeganeh
Street address
Mahdieh Street - next to the People's Park
City
Hamedan
Province
Hamadan
Postal code
6717225708
Phone
+98 81 3838 1025
Fax
+98 81 3262 1515
Email
booali@ac.ir
Web page address
http://192.168.20.42/hospw
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza borzou
Street address
Hamedan - Shahid Fahmideh Street - in front of People's Park
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3252 0184
Fax
+98 81 3252 0188
Email
Webda@umsha.ac.ir
Web page address
https://www.umsha.ac.ir/
Grant name
No
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza Borzou
Position
Associate Professor Hamadan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Hamedan - Shahid Fahmideh Street - in front of People's Park
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3252 0182
Fax
+98 81 3252 0184
Email
borzou@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza borzou
Position
Associate Professor Hamadan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing education
Street address
Hamedan - Shahid Fahmideh Street - in front of People's Park
City
Hamedan
Province
Hamadan
Postal code
38698 65178
Phone
+98 81 3838 0545
Fax
+98 81 3838 0447
Email
borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyed Reza borzou
Position
Associate Professor Hamadan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursing Education
Street address
Hamedan - Shahid Fahmideh Street - in front of People's Park
City
Hamedan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0545
Fax
+98 81 3838 0447
Email
borzou@umsha.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available