Purpose of the study is to discuss the effect of aromatherapy on severity of pain and anxiety after cesarean section. This measurement would be done last to 48 hours after surgery by Spielberg-er standard questionnaire and visual analogue scale. Scent consumed in intervention group was Damask rose and Lavender aroma. Studied population are all women who referred to Motaharie hospital in Jahrom, being operated by cesarean method that achieve participation minimal. Sample size estimation is 90 person. Before surgery, patients divided into three groups by simple random allocation:
1) Instance 2) Intervention(with Lavender) 3) Intervention(with Damask rose)
At first group, after admitting patient into maternity ward, anxiety and pain level will be recorded without any further proceedings. At second group, after admission, researcher would dipped cotton with lavender aroma and attach it to patient clothing. At third group, researcher would dipped cotton with damask rose aroma and attach it to patient clothing as well. Then their level of anxiety and pain will be recorded.
After surgery and further entry to the ward, necessary interventions would be done beside pain and anxiety measurements every 30 minutes for duration of six hours. Patients suffering from chronic and cancer pains, psycho-social problems and those who are allergic to mentioned flavors will be excluded. All patients should be consciously involved in the study. It is expected that interventions cause anxiety and pain relief, beside satisfaction increase, from this non-pharmacological pain control method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092814049N7
Registration date:2017-11-18, 1396/08/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-18, 1396/08/27
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effectiveness of Damask rose and lavender scent on severity of pain and anxiety after Cesarean section, through women.
Public title
Post-surgery effect of aromatherapy on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: All patients who are about to undergo crusher surgery through the skin in Motahari Hospital affiliated with Jahrom University of Medical Sciences and spinal anesthesia can be done for them. Informed consent to participate in this study is among the main inclusion criteria. Exclusion criteria: Sensitivity to roses and Lavender; education lower that primary; developing chronic and cancerous pain; hearing or speech loss; lack of mental health; chronic use of drugs and sedatives; Unstable hemodynamic status; expressed dissatisfaction to continue research.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Double blind method has been used in this study so that the 1- The volunteer and 2- The person who records pain and anxiety are not aware of measurement methods in intervention and control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Approval date
2017-09-20, 1396/06/29
Ethics committee reference number
JUMS.REC.1396.056
Health conditions studied
1
Description of health condition studied
Severity of pain after Aroma Therapy
ICD-10 code
R52.0
ICD-10 code description
Acute pain
2
Description of health condition studied
The level of anxiety after Aroma Therapy
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders
Primary outcomes
1
Description
Pain in the Abdomen and Pelvis
Timepoint
Every 6 hours after surgery With in 24 hours(1 days)
Every 4 hours after intervention With in 24 hours(1 day)
Method of measurement
Spielberger questionnaire
Intervention groups
1
Description
After admitting patient into maternity ward, anxiety and pain level will be recorded without any further proceedings.
Category
N/A
2
Description
At firs intervened group, three drops of aromatherapy combination consist of lavender essence would be dipped on cotton; then the patient would be asked to smell it from 10 centimeters far for duration of 30 minutes.
Category
N/A
3
Description
At second intervened group, three drops of aromatherapy combination consist of damask rose essence would be dipped on cotton; then the patient would be asked to smell it from 10 centimeters far for duration of 30 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Vahid Zarean
Street address
Motahhari Blvd, Jahrom Jahrom Fars
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Solh Ju Kavos
Street address
Vice chancellor for research, Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom
City
Jahrom
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, Jahrom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Vahid Zarean
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 3743 8517
Fax
Email
vahidzaran13@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abbasi Jahromi Ali
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 7156474254600
Fax
Email
AbbasiJa@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom university of medical science
Full name of responsible person
Vahid Zarean
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)