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Comparison of the effect of foot reflexology massage with and without black seed oil on pain, nausea and vomiting, hemodynamic indicators and recovery quality of elective caesarean section patients under spinal anesthesia.

Protocol summary

Study aim
The effectiveness of these non-pharmacological methods in controlling pain, nausea and vomiting, hemodynamic indicators and the quality of recovery after surgery
Design
A parallel randomized clinical trial with a control group, on 102 patients, used Block randomization for randomization.
Settings and conduct
Place of performance: Imam Ali (a.s.) educational and therapeutic hospital in the surgical and operating room departments. Intervention group with black seed oil: pressure on three sensitive points the solar plexus, pituitary gland and heart with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. Intervention group with baby oil: same as the previous group with the difference in the use of baby oil Control group, touch without pressure in the form of gentle superficial massage at the same point Blinding patients, to separate patients in a private environment from screens, to isolate patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:Pregnancy term - 18-45 years old - no touch - no sensitivity to touch - no drug addiction - no problems in speech, hearing and vision - elective caesarean sectionExclusion criteria: spinal contraindications - preeclampsia - emergency cesarean
Intervention groups
Intervention group with black seed oil pressure on three sensitive points, solar plexus, pituitary gland, and heart, with the thumb. intervention group with baby oil: pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. Control group, touch without pressure
Main outcome variables
pain, severity of nausea and vomiting, hemodynamic indicators, quality of recovery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230208057364N1
Registration date: 2023-03-10, 1401/12/19
Registration timing: registered_while_recruiting

Last update: 2023-03-10, 1401/12/19
Update count: 0
Registration date
2023-03-10, 1401/12/19
Registrant information
Name
Maryam Pouramanyanhir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4415 1828
Email address
pouramanyanmaryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of foot reflexology massage with and without black seed oil on pain, nausea and vomiting, hemodynamic indicators and recovery quality of elective caesarean section patients under spinal anesthesia.
Public title
Comparison of the effect of massage with and without black seed oil on pain, nausea and vomiting of caesarean section patients using lumbar anesthesia.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Term of pregnancy Being 18-45 years old Not having a lesion at the place of application of touch Insensitivity to touch or massage No drug addiction Having no problems in speech, hearing and vision Not having known mental disorders Elective caesarean section Not having spinal restrictions No medical problems and no midwifery problems after surgery such as heavy bleeding Not having crises such as a history of divorce, loss of loved ones and immigration in the last 6 months
Exclusion criteria:
The presence of spinal contraindications Presence of preeclampsia Emergency caesarean section Conversion of spinal anesthesia to general anesthesia for any reason Hemodynamic instability Lack of consent to participate in the research Migration Divorce
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Parallel randomized clinical trial - patients are continuously referred and then entered into the study based on the type of random allocation. This research will be allocated to three groups of foot reflex massage with oil (O), foot reflex massage without oil (W), control (C) or routine before starting the study by block randomization method. The blocks of this research are 6 (OO, WW, CC) and 27 states will be created. First, the possible states of these 6 letters inside the blocks will be determined, and then the numbers of the blocks will be determined in a simple random manner using a table of random numbers. In this way, the type of intervention based on the desired letters will be determined with the number of each patient and will be kept in a master sheet, and finally, the intervention number of each patient will be inserted on a sheet when visiting and the type of intervention will be known at that moment (entry number The patient records are entered on the envelope and the type of intervention or control is specified inside the envelope. Gradually, according to the presence of eligible patients, the corresponding envelope is returned, and the type of intervention that is inside the non-transparent envelope is specified, and the desired technique will be done.)
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 Mazandaran University of Medical Sciences
Street address
Serah Joibar, the beginning of Vali Asr Highway (AJ), the headquarters of Mazandaran University of Medical Sciences and Health Services
City
Amol
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.MAZUMS.REC.1401.500

Health conditions studied

1

Description of health condition studied
Nausea and vomiting - pain - duration of discharge from recovery - hemodynamic indicators - digestive index (constipation) - shaving - urinary output - reflex massage - cesarean section - spinal anesthesia - black seed
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determining the postoperative pain level of patients at the time of discharge from recovery, 24 and 48 hours after surgery in caesarean section patients in the reflex massage groups with and without black seed oil and their control group, this scale was a ten-centimeter horizontal ruler ranging from zero to It was graded ten. The number zero indicated the absence of pain symptoms and the number ten meant the maximum intensity of the desired symptoms.
Timepoint
Post-operative pain level, recovery time, 24 and 48 hours after the operation and after reflexology massage with and without black seed oil.
Method of measurement
Visual analogue scale is used to measure the pain of the operation site

2

Description
Determining the severity of nausea in patients during surgery, after surgery and 24 hours after surgery in caesarean section patients of reflexology massage groups with and without black seed oil and their control group, the visual scale for registering the severity of nausea is a self-report scale. Nausea with a grade above 7 is classified as severe, between 3.5 and 7 as moderate, and less than 3.5 as mild.
Timepoint
Determining the severity of nausea in patients during surgery, after surgery and 24 hours after surgery and after reflexology massage with and without black seed oil.
Method of measurement
Visual scale

3

Description
To evaluate the amount of vomiting, counting the number of times vomiting is used. Vomiting more than 5 times is defined as severe, between 3-5 times as moderate and less than 3 times as mild.
Timepoint
The amount of nausea and vomiting is measured after the intervention, during the operation, after the operation and 24 hours after the operation.
Method of measurement
Visual scale

4

Description
Measurement of hemodynamic indicators (systolic and diastolic blood pressure, pulse and spo2)
Timepoint
Before the operation, after the birth of the baby and after the last suture in the cesarean section
Method of measurement
Monitoring device

5

Description
Measuring the duration of recovery in two time periods
Timepoint
The moment of entering recovery and the time of discharge from recovery after applying massage
Method of measurement
It is recorded in minutes

Secondary outcomes

1

Description
Determining postoperative headache in patients
Timepoint
Recovery time, 24 and 48 hours after the operation
Method of measurement
The measurement of headache is a visual analogue scale, this scale was a ten-centimeter horizontal ruler graded from zero to ten. The number zero indicates the absence of pain symptoms and the number ten means the maximum intensity of the symptoms

2

Description
2. Determining shivering of patients
Timepoint
During recovery
Method of measurement
By observing the patient during recovery and at four levels, the absence of muscle tremors is scored as zero, straightening of hair, peripheral cyanosis: 1, visible muscle tremors in one muscle group: 2, visible muscle tremors in more than one muscle group: 3 and muscle tremors. Visible in all the muscles of the body: 4

3

Description
6. Digestive index (constipation)
Timepoint
24 and 48 hours after the operation
Method of measurement
The checklist of digestive complications is constipation. Constipation by asking the patient and the information entered in the patient's file in terms of passing gas, straining, flatulence, abdominal pain, firm consistency, lack of defecation.

4

Description
Determination of urinary output of patients
Timepoint
During operation, exit from recovery and 12 hours later in patients
Method of measurement
Urinary output is measured by a questionnaire. After the implementation of foot reflex massage interventions with and without black seed oil through the inserted urinary catheter, he will do it by observing the urine bag and the patient's file.

Intervention groups

1

Description
Intervention group: The first intervention group: The intervention group (reflex massage of the soles of the feet): pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular clockwise and continuously on the reflective points without breaking the contact with the skin and will be done with black seed oil (Barij company).Before the intervention, in order for the researcher's hand to have more contact with the massage area, the patient's feet were first cleaned using a wet towel, then the researcher performed reflex foot massage without using cream or emollient with black seed oil in the intervention group for 20 minutes (10 minutes for each foot) and it is done first on the left foot and then on the right foot. If there is edema in the client's leg, more pressure is applied to perform the techniques.
Category
Prevention

2

Description
Intervention group: The second intervention group: reflex massage of the soles of the feet: pressure on three sensitive points, which are the solar plexus, pituitary gland, and heart, with the thumb. This pressure is to the extent that the upper third of the researcher's thumb turns white, and then massage is given to all the soles of the feet in a circular manner. The meaning of massage in this study is a 20-minute foot massage (10 minutes after the patient is stabilized on the operating bed and 10 minutes during recovery and 3 seconds of rest for every 2 minutes of direct pressure). The movement of the thumb or other fingers is circular in the clockwise direction and continuously on the reflex points without breaking the contact with the skin and will be done with baby oil (Firooz Company). First, the patient's feet were cleaned using a wet towel, then the researcher performed a reflex foot massage without using cream or softener with black seed oil in the intervention group for 20 minutes (10 minutes on each foot, first on the left foot and then on the right foot). will be If there is edema in the client's leg, more pressure is applied to perform the techniques.
Category
Prevention

3

Description
Control group: The touch without pressure will be applied with the same pattern as the sole reflex massage groups as a superficial and gentle massage at the same point.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali (AS) Hospital
Full name of responsible person
Dr. Alireza Yahyai Shahandashti
Street address
Sheikh Fazlullah Nouri Street, km 2, Chamestan Road, Imam Ali Hospital
City
Amol
Province
Mazandaran
Postal code
46171 41497
Phone
+98 11 4426 4661
Email
EmamAlihospital@yahoo.com
Web page address
https://bankpezeshkan.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
No.2, Third Floor,Mazandaran University of Medical Sciences and Health Services Building,Research and Technology Vice-Chancellor,Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817893134
Phone
+98 11 3448 4874
Email
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
Dr. Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Kilometer 17 of Farah Abad Road, Prophet Azam University Complex, Faculty of Paramedicine
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 2469
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
Dr. Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Prophet Azam University Complex, Paramedical FacultyKm 17 Khazar Abad Road,Khazar Square
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 2469
Email
rezanf2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Khazar Square, Km 17 Khazar Abad Road, Prophet Azam University Complex, Paramedical Faculty
City
Sari
Province
Mazandaran
Postal code
7771
Phone
+98 11 3354 2469
Email
rezanf2002@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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