Protocol summary
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Study aim
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The effect of chamomile aromatherapy with and without oxygen on the severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia
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Design
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The study was a clinical trial with control group performed on 136 women who underwent cesarean section and randomly assigned to 3 intervention groups and one control group.
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Settings and conduct
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136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 12, 18 hours after cesarean section
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: No history of middle ear disease, no preeclampsia or eclampsia. No smoking or alcohol. No history of chamomile allergies. No history of olfactory problems. Cesarean section should be performed with spinal anesthesia
Change the anesthesia method
Exclusion criteria: Perform cesarean section other than cesarean section. Ill get ill and require more or less than the prescribed oxygen level. Patient needs intensive care
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Intervention groups
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.Intervention group received chamomile Essence oil with simple mask and small nebulizer, second group oxygenated with simple mask alone, third group received aromatherapy with nebulizer alone and control group received no intervention
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Main outcome variables
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Pain, bloating, nausea
General information
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Reason for update
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At the beginning of the study, changes were made in the intervention times and measurement times. These changes were recorded
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141222020401N7
Registration date:
2020-01-05, 1398/10/15
Registration timing:
registered_while_recruiting
Last update:
2022-12-15, 1401/09/24
Update count:
2
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Registration date
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2020-01-05, 1398/10/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-05, 1398/10/15
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Expected recruitment end date
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2020-03-18, 1398/12/28
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Actual recruitment start date
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2020-01-05, 1398/10/15
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Actual recruitment end date
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2020-03-18, 1398/12/28
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Trial completion date
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2020-03-19, 1398/12/29
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Scientific title
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The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
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Public title
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The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
no history of middle ear disease, preeclampsia or eclampsia, asthma and other acute and chronic diseases
No smoking or alcohol drinking
No history of allergy to chamomile
No history of olfactory problems
Cesarean section should be performed with spinal anesthesia
Exclusion criteria:
Change the anesthesia method
Other than cesarean section
The patient needs special care
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
136
Actual sample size reached:
136
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomized block allocation method with standard 4-person blocks was used and the subjects were divided into 3 intervention groups and one control group, with labels A, B, C, D on four sheets and and oxygen interventions. Aromatherapy, oxygen therapy, aromatherapy and control were also written on four separate sheets, and a colleague who was unaware of this was asked to randomly remove a label for each intervention. In this way we had four random groups and four factorial twenty-four blocks. The size of each block was four and their order was different. Then the blocks were randomly assigned by placement and the patients were sorted. Each block of patients was assigned randomly.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the smell of chamomile, it was not possible to blind the researcher and participants, but the analyst has no information about the type of intervention related to each data.
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-25, 1398/04/04
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Ethics committee reference number
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IR.YUMS.REC.1398.036
Health conditions studied
1
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Description of health condition studied
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pain, nausea and distention of women in post Cesarean section with spinal anesthesia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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bloating
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Timepoint
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6 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section
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Method of measurement
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visual analog scale
2
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Description
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pain
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Timepoint
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6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
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Method of measurement
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visual analog scale
3
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Description
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nausea
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Timepoint
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6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
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Method of measurement
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visual analog scale
Intervention groups
1
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Description
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Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
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Category
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Prevention
2
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Description
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Dual Oxygen Intervention alone, Double Intervention at the same time will receive 6 liters of oxygen per minute with simple face mask without aromatherapy chamomile
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Category
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Prevention
3
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Description
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Intervention group: Intervention third chamomile aromatherapy alone, Intervention group three will receive chamomile aromatherapy at the same time after sensitization test with oxygen nebulizer
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Category
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Prevention
4
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Description
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The control group did not receive oxygen and aromatherapy chamomile.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yasouj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable