Mothers experience many physiological, mental and social changes at postpartum period. In early stage of postpartum deal with some issues such as after pain, preneal pain and fatigue. Aromatherapy is one of the fastest growing therapies in the world today. Lavender has long been involved in traditional medicine. This study examined the effect of lavender aromatherapy on maternal somatic pain, fatigue and mood in the early hours after delivery.
Method: This randomized clinical trial study on nullipar women after natural vaginal delivery. Essential oil of lavender (1%) based on sesame oil was used in case group. Five drop of essence squeezed on three layers of kleenex and participants hold it in 20 cm of their noses for 15 minutes and do respiration. Then in two group of case and control the intervention repeated 6 hours after first intervention and before sleep. After 24 hours of first intervention all of variants remeasured. In the control group used sesame oil of oila company. Severity of fatigue is determined by three domains such as mental, cognitive and psychological, severity of preneal pain and severity of physical pain is measured by visual analog scale (MCGill). Used as the experimental group. Mood is measured with Positive And Negative Affect Scale (PANAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060910327N7
Registration date:2014-07-01, 1393/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-01, 1393/04/10
Registrant information
Name
Farideh Vaziri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9131
Email address
vazirif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-06, 1393/01/17
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on maternal somatic pain, fatigue and mood in the early hours after delivery
Public title
The effect of lavender aromatherapy on maternal somatic pain, fatigue and mood in the early hours after delivery admitted
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous; natural vaginal delivery; Age between 18 to 35 years; by episiotomy
Exclusion criteria: allergic to Lavender
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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
Central building Shiraz University of Medical Sciences, Zand Ave, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2014-03-19, 1392/12/28
Ethics committee reference number
92-6943
Health conditions studied
1
Description of health condition studied
Relationship of lavender aromatherapy on maternal somatic pain, fatigue and mood in the early hours after delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Prineal pain
Timepoint
One to four hours after delivery
Method of measurement
Visual Analog Scale for pain
2
Description
Fatigue
Timepoint
One to four hours after delivery
Method of measurement
Visual Analog Scale for fatigue
3
Description
Physical pain
Timepoint
One to four hours after delivery
Method of measurement
Visual Analog Scale
4
Description
Mood
Timepoint
One to four hours after delivery
Method of measurement
Positive And Negative Affect Scale (PANAS)
Secondary outcomes
1
Description
Prineal pain
Timepoint
Before, One hours after the first intervention, In the morning after the intervention
Method of measurement
Visual Analog Scale
2
Description
Fatigue
Timepoint
Before, One hours after the first intervention, In the morning after the intervention
Method of measurement
Visual Analog Scale for fatigue
3
Description
Physical pain
Timepoint
Before, One hours after the first intervention, In the morning after the intervention
Method of measurement
Visual Analog Scale
4
Description
Mood
Timepoint
Before, One hours after the first intervention, In the morning after the intervention
Method of measurement
Positive And Negative Affect Scale (PANAS)
Intervention groups
1
Description
Intervention group: Essential oil of lavender (1%) based on sesame oil was used in case group. Five drop of essence squeezed on 3 layers of kleenex and participants hold it in 20 cm of their noses for 15 minutes and do respiration.The intervention repeated 6 hours after first intervention and before sleep. After 24 hours of first intervention all of variants remeasured.
Category
Treatment - Drugs
2
Description
control group: In the control group used sesame oil. Five drop of essence squeezed on 3 layers of kleenex and participants hold it in 20 cm of their noses for 15 minutes and do respiration. Then in two group of case and control the intervention repeated 6 hours after first intervention and before sleep. After 24 hours of first intervention all of variants remeasured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shiraz Hafez Hospital
Full name of responsible person
Miss Zeinali
Street address
The beginning of Chamran Blv, Shiraz, Fars
City
Shiraz
2
Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Miss Gholami
Street address
Defa Moqadas Square, Shiraz, Fars
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President for research of Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
7th Floor, Shiraz University of Medical Sciences, Central building, Zand Ave, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President for research of Shiraz 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
Faculty of Nursing and Midwifery
Full name of responsible person
Farideh Vaziri
Position
Master of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 1647 4252
Fax
Email
Vazirif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty OF Medical
Full name of responsible person
Zahra Najib
Position
Gynecologist
Other areas of specialty/work
Street address
Faculty of Medical , Zand Ave, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
Email
Vazirif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Of Nursing And Midwifery
Full name of responsible person
Mahsa Shiravani
Position
Master oF Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing And Midwifery, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
Shiravani_m@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)