Determining the comparison of the effect of plantar reflexology with and without violet oil on fatigue and pain after cesarean section in patients referred to Tohid Jam Hospital in Bushehr, 2021
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 126 patients. Randomizer software was used for randomization.
Settings and conduct
From the patients referred to Tohid Jam hospital in Shiraz, based on the inclusion criteria, 126 samples were selected by convenience sampling method and randomly assigned to a control group and two intervention groups using Randomizer web-based software. One-way blinding and intervention and control groups are not aware of the type of intervention. Sealed consecutive matte envelopes were used to conceal the allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being 18-45 years old; Literacy; Perform cesarean section with spinal anesthesia; Complete pregnancy and healthy baby and high Apgar score of the first minute; No allergies to used oils; No skin problems in the massage area; Do not use narcotic sedatives in the last eight hours; Do not be under general anesthesia. Exclusion criteria: Having severe postoperative complications such as excessive bleeding, infection, eclampsia, hospitalization in intensive care units; Reluctance to continue cooperation during stages 2 and 3.
Intervention groups
Group 1: In the first group, the reflexology intervention of the sole of the foot will be performed with violet oil.
Second group: In the second group, the reflexology intervention of the sole of the foot will be performed without violet oil.
The third group: in this group are cesarean section patients who are not subjected to any intervention.
Main outcome variables
Fatigue, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211204053272N1
Registration date:2022-01-01, 1400/10/11
Registration timing:prospective
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Esmat Mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
esmatmardani6609@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
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
A Comparision Study of the Effect of foot reflexology with and without violet oil on fatigue, pain after cesarean section in patients
Public title
The effect of plantar reflexology on fatigue and pain after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being 18-45 years old
Literacy
Perform cesarean section with spinal anesthesia
Complete pregnancy and healthy baby and high Apgar score of the first minute
No allergies to used oils
No skin problems in the massage area
Do not use narcotic sedatives in the last eight hours
Do not be under general anesthesia
Exclusion criteria:
Having severe postoperative complications such as excessive bleeding, infection, eclampsia, hospitalization in intensive care units
Reluctance to cooperation during stages 2 and 3
Age
From 18 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple and individual way using Randomizer random allocation software. Individuals are listed according to the national code and then divided into groups 1 (reflexology with violet oil), group 2 (reflexology without oil) and group 3 (control) using random allocation software.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher knows which patient is in the control group and which is receiving reflexology with oil or without oil. Patients are not aware of their groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences, Shiraz,Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.036
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Fatigue
Timepoint
Before studying and one hour after studying
Method of measurement
Multidimensional Fatigue Inventory scale
2
Description
Pain
Timepoint
Before studying and one hour after studying
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The reflexology intervention of the sole of the foot will be performed with violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform a foot reflexology with 3-5 cc of violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.
Category
Treatment - Drugs
2
Description
Intervention group 2: The foot reflexology intervention will be performed without violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform foot reflexology without violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.
Category
Treatment - Other
3
Description
Control group: In this group are cesarean section patients who are not subjected to any intervention. Patients in this group are only monitored. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Jam Hospital in Bushehr
Full name of responsible person
Esmat Mardani
Street address
Jam city, Tohid town, Tohid Jam hospital, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
7558174946
Phone
+98 77 3762 3003
Email
Esmatmardani6609@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ghavi
Street address
Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
ghavi.fatemeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
65
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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ghavi
Position
Instructor of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3644 7254
Email
ghavi.fatemeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ghavi
Position
Instructor of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
ghavi.fatemeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ghavi
Position
Instructor of Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
ghavi.fatemeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Article
When the data will become available and for how long
2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
1- Reference in articles and dissertations 2- Having a code of ethics in your studies 3- Valid academic emails
From where data/document is obtainable
Esmat Mardani
Hazrat Fatemeh Shiraz School of Nursing and Midwifery
Esmatmardani6609@gmail.com
00989173894438
What processes are involved for a request to access data/document