The Comparison of the Effect of Lavender Essence and Chamomile Essence on pain severity after cesarean section under spinal anesthesia: A blind placebo-controlled randomized clinical trial.
This study is conducted in order to compare the influence of Lavender Essence and Chamomile Essence on pain severity after cesarean section under general anesthesia. The study is a blind placebo-controlled randomized clinical trial. It would be done in Phase II clinical trials and single-center. The study population is cesarean section candidates in Besat Hospital in Sanandaj. Based on inclusion criteria, reduction samples probability and Purposeful sampling, 129 participants are selected; Then based on drawing a sealed envelopes from number one to three for each patient, the samples are allocated into three groups. Inclusion criteria included; surgical candidates; volunteered to participate in the study; lack of underlying chronic medical conditions; under spinal anesthetic with a specific drug, Get hundred mg diclofenac suppository in the recovery room, having more than three in the visual analog scale pain after surgery. Exclusion criteria included Patient’s withdrawal from the research, and unpredicted events after surgery such as cardiac arrest or patient’s death. As having pain more than 3 scales; In the first intervention group, two drops of lavender essence and In the second intervention group, two drops of Chamomile essence is poured on a cotton swab. In the control group, Two drops of placebo (normal saline) is poured on cotton swabs and the patient is asked to inhale it. Pain is measured by a second researcher. second researcher as pain scale evaluator is blind to placebo and kinds of interventions. Based on Visual Analog Scale (VAS); severity of pain is recorded from zero to ten. Demographic information, Severity of pain and uage of analgesics after intervention are recorded in the information sheet.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016081726861N2
Registration date:2016-09-27, 1395/07/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-27, 1395/07/06
Registrant information
Name
Jamal Seidi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3182 7464
Email address
jamal.seidi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Lavender Essence and Chamomile Essence on pain severity after cesarean section under spinal anesthesia: A blind placebo-controlled randomized clinical trial.
Public title
The Comparison of the Effect of Lavender Essence and Chamomile Essence on pain severity after cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: Cesarean section candidates (after surgery); being volunteer to participate in the study; lack of underlying medical conditions (diabetes, chronic respiratory disease, chronic heart disease, kidney or liver disorders and other acute or chronic disorders); surgery under spinal anesthesia; Get 100-mg diclofenac suppository in the recovery room; getting more than three scores of pain severity using the visual analog scale after surgery. Exclusion criteria included Patient’s unwillingness from continuing the study, and unpredicted events after surgery such as cardiac arrest or patient’s death.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random allocation is based on using the draw without placing a sealed envelope which contain number one, two or three. There are 129 sealed envelopes including 43 sealed envelopes contains number one for lavender essence group; 43 sealed envelopes contains number two for chamomile essence group and 43 sealed envelopes contains number three for placebo group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj, postal code:13446-66177
City
Sanandaj
Postal code
13446-66177
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.MUK.REC.94.122
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Pain
Timepoint
As having pain more than 3 scales; from discharging recovery till 6 hours after surgery
Method of measurement
Based on Visual Analog Scale (VAS); severity of pain is recorded from zero to ten
Secondary outcomes
1
Description
the rate of consumption of analgesic
Timepoint
after the intervention
Method of measurement
Based on the frequency of use and dose of medication in information sheet
Intervention groups
1
Description
Intervention group1: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of lavender essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.
Category
Treatment - Drugs
2
Description
Intervention group2: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of Chamomile essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.
Category
Treatment - Drugs
3
Description
Placebo group: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of normal saline are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Bbaharreh Najafi
Street address
Besat Hospital, Keshavarz Street, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaee
Street address
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446
City
Sanandaj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences