Effect of inhalation aromatherapy with lavender essence versus placebo on physiological indicators and intensity of venipuncture pain in hospitalized preschool children in pediatric unit: a single blinded non randomized clinical trial
Objective: effect of inhalation aromatherapy with lavender essence on physiological indicators and intensity of venipuncture pain in hospitalized preschool children in pediatric unit. Design: single blinded non randomized clinical trial. Setting and conduct: the children with following criteria will be enrolled into the study; a) Age 3 to 6 years; b) Having normal children's mental, verbal, visual and auditory abilities; c) Absence of any acute or chronic pain before venipuncture; d) Absence of diseases such as asthma, allergies, dermatitis and rhinitis according to the discretion of the physician. Exclusion criteria included: a) Incidence any kind of allergy to lavender essence during aromatherapy according to the discretion of the physician; b) Existence any problem to continue participating in the study. Intervention1: the physiological indicators of children will be measured in half an hour before entering into the venipuncture room and the children inhale 5 drops of lavender essence 2% which was poured onto 10×10 cm gauze attached to collar of children shirt in 20 minutes. Then, physiological indicators will be measured immediately after fixation of catheter and in minutes of 5 and 10 after exiting of venipuncture room. Intensity of pain will be measured in times of immediately, 5 and 10 after exiting of venipuncture room. Intervention2: The physiological indicators of children will be measured in half an hour before entering into the venipuncture room and the children inhale 5 drops of distilled water (placebo) which was poured onto 10×10 cm gauze attached to collar of children shirt in 20 minutes. Then, physiological indicators will be measured immediately after fixation of catheter and in minutes of 5 and 10 after exiting of venipuncture room. Intensity of pain will be measured in times of immediately, 5 and 10 after exiting of venipuncture room. Blinding: both lavender essence and distilled water (placebo) are prepared in dark and similar containers so children will not be aware of the kind of inhaler. Main outcome measures: heart rate and percent of arterial oxygen saturation will be measured by pulse-oximetry, respiratory rate by counting in one minute. Intensity of pain will be measured by Oucher pain scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503089759N6
Registration date:2015-06-14, 1394/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-14, 1394/03/24
Registrant information
Name
Ali Bikmoradi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0439
Email address
bikmoradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-07-01, 1394/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inhalation aromatherapy with lavender essence versus placebo on physiological indicators and intensity of venipuncture pain in hospitalized preschool children in pediatric unit: a single blinded non randomized clinical trial
Public title
Effect of aromatherapy on physiological indicators and intensity of pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: a) Age 3 to 6 years; b) Having normal children's mental, verbal, visual and auditory abilities; c) Absence of any acute or chronic pain before venipuncture; d) Absence of diseases such as asthma, allergies, dermatitis and rhinitis according to the discretion of the physician. Exclusion criteria: a) Incidence any kind of allergy to lavender essence during aromatherapy according to the discretion of the physician; b) Existence any problem to continue participating in the study.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sampling is conventional and eligible children to enter the study in two separate stages on two experimental and control groups will be entered in the study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
30 min before entering into the venipuncture room, immediately after fixation of catheter and 5 and 10 minutes after leaving the venipuncture room.
Method of measurement
Heart rate and percent of arterial oxygen saturation will be measured by pulse oximetry, respiratory rate by count researcher in one minute
Secondary outcomes
1
Description
Intensity of pain
Timepoint
Immediately, 5 and 10 minutes after leaving the venipuncture room
Method of measurement
Oucher pain scale
Intervention groups
1
Description
Intervention1: the physiological indicators of children will be measured in half an hour before entering into the venipuncture room and the children inhale 5 drops of lavender essence 2% which was poured onto 10×10 cm gauze attached to collar of children shirt in 20 minutes. Then, physiological indicators will be measured immediately after fixation of catheter and in minutes of 5 and 10 after exiting of venipuncture room. Intensity of pain will be measured in times of immediately, 5 and 10 after exiting of venipuncture room.
Category
Treatment - Drugs
2
Description
Intervention2: The physiological indicators of children will be measured in half an hour before entering into the venipuncture room and the children inhale 5 drops of distilled water (placebo) which was poured onto 10×10 cm gauze attached to collar of children shirt in 20 minutes. Then, physiological indicators will be measured immediately after fixation of catheter and in minutes of 5 and 10 after exiting of venipuncture room. Intensity of pain will be measured in times of immediately, 5 and 10 after exiting of venipuncture room.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Educational and Therapeutic Center
Full name of responsible person
Masoome Khaleghverdi
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
vice chancellor for research Hamadan University of Medical Sciences, Hamadan University of Medical Sciences, Shahid Fahmide Street, Hamadan
City
Hamadan
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, Hamadan 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
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shahid Fahmideh, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
Dr. Ali Bikmoradi
Position
Medical Education Management
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Street, Hamadan
City
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
bikmoradi@umsha.ac.ir; abeikmoradi@yahoo.com
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)