Protocol summary

Study aim
Determining the effect of deep breathing with and without rosemary on pain, sleep quality and hemodynamic indicators during and after orthopedic surgery of the upper limb in reference to 17 Shahrivar Amol Hospital in 2023
Design
It is a three-arm parallel randomized clinical trial with a sample size of 102 people in a continuous, accessible and random allocation manner.
Settings and conduct
In the hospital on 17th Shahrivar Amol, the breathing group with and without rosemary will perform deep breathing 12 times in the morning and 12 times in the evening for 7 days. The insert envelope and the type of intervention or control are specified inside the envelope.
Participants/Inclusion and exclusion criteria
Admission: over 18 years old, ability to read and write and communicate in Persian language; presence of any fractures and tears in the upper limbs (surgery time 30 minutes to 3 hours); full alertness; not suffering from respiratory diseases such as asthma, bronchitis and emphysema, not smoking; no pregnancy and breastfeeding; no allergy to rosemary; ASA1 and ASA2 anesthesia class one and two. Withdrawal: refusal to continue the study; creating an unwanted cardio-respiratory complication during anesthesia and surgery; suffering from compartment syndrome.
Intervention groups
Breathing group with rosemary while the necklace containing rosemary essential oil is poured on cotton and placed at a distance of 20 cm from the person's nose, deep breathing is done lying down and sitting. The deep breathing group without rosemary is similar to deep breathing with rosemary and only from Normal saline will be used and routine procedures will be performed and recorded in the control group
Main outcome variables
Pain at the operation site; pain at the tourniquet site; sleep quality; hemodynamic indices; awareness and recall of events during anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230209057374N1
Registration date: 2023-04-13, 1402/01/24
Registration timing: registered_while_recruiting

Last update: 2023-04-13, 1402/01/24
Update count: 0
Registration date
2023-04-13, 1402/01/24
Registrant information
Name
Bahare Rozgard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4415 5676
Email address
bahare.rozgard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-07-20, 1402/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of deep breathing with and without rosemary on pain, sleep quality and hemodynamic indicators during and after upper limb orthopedic surgery
Public title
Comparison of the effect of deep breathing with and without rosemary on pain, sleep quality and hemodynamic indicators in upper limb orthopedic surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age The ability to read and write and communicate in Persian The presence of any fractures and tears in the upper limbs (which will take approximately 30 minutes to 3 hours for surgery) Being fully alert Not suffering from any disease have respiratory problems such as asthma, bronchitis and emphysema Not smoking Not pregnant or breastfeeding Not allergic to rosemary Class one and two anesthesia ASA1 and ASA2
Exclusion criteria:
Discontinuing the study Unwanted cardiovascular and respiratory complications during anesthesia and surgery Suffering from compartment syndrome
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
For this research, before the start of the study, after obtaining informed consent before the operation, the patients are referred continuously and available, and with the block randomization method, they are divided into three groups: deep breathing without rosemary (B), deep breathing with rosemary (R). , control (C) or routine will be assigned. The blocks of this study are 6 (BB, RR, CC) and 27 states will be created, first determine the possible states of these 6 letters inside the blocks and then randomly and using the table of random numbers number 17 from the block. which will be the completion of the number of samples will be determined (1-27) and in this way the type of intervention will be determined based on the desired letters with the number of each patient and will be kept in a master sheet and the continuous entry number of the patients will be inserted on the envelope respectively And the type of intervention or control is specified inside the envelope. Gradually, according to the presence of eligible patients, the relevant envelope is returned, and the type of intervention that is inside the non-transparent envelope is determined and the desired technique is performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patients, the same cotton necklace is used for all patients, although the cotton impregnated with rosemary essential oil contains perfume, an effort is made to ensure that there is no communication between the patients during the study period. And to blind the researchers, the opening of the envelope was done by the secretary of the department, who has no role in the evaluation of the groups, and the person who measures the variables is not aware of the type of intervention. Considering the different forms of providing services to the study groups, the behaviors in dealing with the three groups are tried to be similar in terms of having a cotton necklace dipped in rosemary oil or normal saline and without these items. However, it is not possible to completely blind due to the smell of rosemary.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Journal Office - Research and Technology Deputy - Third Floor - Building No. 2, Mazandaran University of Medical Sciences and Healthcare Services - Moalem Square - Sari
City
Sari
Province
Mazandaran
Postal code
1295498972
Approval date
2023-01-16, 1401/10/26
Ethics committee reference number
IR.MAZUMS.REC.1401.501

Health conditions studied

1

Description of health condition studied
Any tear or fracture in the upper limbs
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Pain score
Timepoint
Recording the pain score of the operation site at the time of discharge from recovery and 24 hours, 48 hours, 4 days and 7 days after surgery
Method of measurement
Visual Analog Scale

2

Description
Tourniquet site pain score
Timepoint
Discharge from recovery and 24 hours after the operation
Method of measurement
Visual Analog Scale

3

Description
Evaluation of sleep quality
Timepoint
Evaluation of sleep quality the night before and the first night after surgery, as well as 48 hours, 4 days and 7 days after surgery.
Method of measurement
Pittsburgh Sleep Quality Questionnaire

4

Description
Examining waking up during anesthesia, symptoms include: dizziness, rapid meiosis in response to light, tears, targeted movements of facial muscles and limbs, sweating, tachycardia, and increased blood pressure in response to painful stimulation (skin incision)
Timepoint
The beginning of surgery (skin incision) and the end of surgery (skin suture)
Method of measurement
Dizziness, rapid meiosis in response to light, tears, targeted movements of facial muscles and limbs, sweating, tachycardia, and increased blood pressure in response to painful stimulation (skin incision)

5

Description
Examining recall of events during anesthesia with questions: hearing the sounds during the operation, feeling the stretch of the viscera and feeling the pain
Timepoint
In 24 hours and 7 days after anesthesia
Method of measurement
Hearing the sounds during the operation, feeling the stretch of the viscera and feeling the pain

6

Description
Registration of hemodynamic indicators including: systolic and diastolic blood pressure, heart rate and arterial blood oxygen
Timepoint
Entering the operating room, during the operation and at the time of discharge from recovery
Method of measurement
Monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: Deep breathing with rosemary while the necklace containing three drops of 4% rosemary essential oil from the essential plant company is poured on cotton and is placed at a distance of 20 cm from the person's nose and the person inhales its aroma, at first there are explanations about Breathing skills, deep breathing and its effects on physical and mental health are given, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the researcher's guidance by the patients, so that in terms of learning and the correct execution of the technique will be controlled and this training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling.
Category
Treatment - Other

2

Description
The second intervention group: deep breathing without rosemary while the necklace containing normal saline is poured on cotton and placed at a distance of 20 cm from the person's nose and the person inhales it, at first explanations about breathing skills, deep breathing and its effects It is given on physical and mental health, then deep breathing training is first done lying down and then sitting up, before the surgery with the help of educational notes and the guidance of the researcher, the patients will be controlled in terms of learning and doing the technique correctly, and this Training will be face-to-face. On the first day, they will do this exercise 12 times at the beginning of the day and 12 times in the evening before dinner, for 15 minutes. To perform abdominal breathing, the patient is taught to lie on his back on the floor and to bend his legs slightly apart from the hip width so that the lower back rests comfortably on the floor. Place the healthy hand on your stomach. Take a slow and deep breath through the nose while slowly expanding the abdominal muscles up and to the side and the belly expands, hold your breath for 5 seconds and then exhale slowly and smoothly through the nose. Exhale all the air from your lungs. The patient looks and pays attention to the abdominal muscles while inhaling and exhaling.
Category
Treatment - Other

3

Description
Control group: the routine procedures of the ward and operating room will be performed and recorded, and they will use a cotton necklace without rosemary and normal saline.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Shahram Kashani
Street address
17 Shahrivar Hospital, 17 Shahrivar Square, Amol, Mazandaran
City
Amol
Province
Mazandaran
Postal code
4615747845
Phone
+98 11 4422 4001
Fax
+98 11 4422 4043
Email
rayane17sh@live.com
Web page address
http://h-17shahrivar.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Sari Research and Technology Vice-Chancellor, 3rd Floor, Moalem Square, Building No. 2, Mazandaran University of Medical Sciences and Healthcare Services
City
Sari
Province
Mazandaran
Postal code
1234568952
Phone
+98 11 3448 4874
Email
jmums@mazums.ac.ir
Web page address
http://jmums.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri Formi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Paramedical Faculty of Sari - University Complex of the Great Prophet - 17 km of Khazarabad Road - Khazar Square - Sari
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 3246
Fax
+98 11 3354 2469
Email
rezanf2002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri Formi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Paramedical Faculty of Sari - University Complex of the Great Prophet - 17 km of Khazarabad Road - Khazar Square - Sari
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 3246
Fax
+98 11 3354 2469
Email
rezanf2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri Formi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Paramedical Faculty of Sari - University Complex of the Great Prophet - 17 km of Khazarabad Road - Khazar Square - Sari
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 3246
Fax
+98 11 3354 2469
Email
rezanf@yahoo.com

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
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