Evaluation and comparison of the effect of aromatherapy and distraction on the Pain Caused by Venipuncture in children admitted to the pediatric ward of Ali ebne Abitaleb Hospital in Zahedan in 1398
Design
Clinical trial with two control groups and one intervention group, community-based and pragmatic, with parallel groups without blinding, randomized, on 90 patients, permutation of permutation modes A, 2 and 3 is used for randomization.
Settings and conduct
Children aged 3-8 years admitted to the pediatric ward of Ali ebne Abitaleb Hospital are randomly divided into three groups (two intervention groups and a control group). In the distraction group, the researcher uses a red hat puppet to talk and play with the child 3 minutes before the venipuncture begins (puppetry). In the aromatherapy group, the child inhales a handkerchief soaked in lavender essential oil attached to the collar of his shirt 20 minutes before the start of the vein. In the control group, only the severity of the child's pain after venipuncture was measured and no intervention was performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range 3 to 8 years
Family and child consent to participate in the study
Non-Inclusion criteria:
Children with asthma or allergies to aromatherapy
Suffering from mental retardation
Take painkillers before venipuncture
Inability to communicate or lack of full consciousness
Intervention groups
In the distraction group, the researcher moves the red hat with the doll's hand and speaks and plays with the child in the language of the doll.
In the aromatherapy group, the child inhales the lavender essential oil poured on a napkin attached to the collar of his shirt.
In the control group, only pain was measured and no intervention was performed.
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041960N2
Registration date:2020-09-20, 1399/06/30
Registration timing:retrospective
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Fateme Avizhgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4487 3295
Email address
avizhgan_f@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Aromatherapy and Distraction on the Pain Caused by Venipuncture in Hospitalized Children
Public title
Comparison of the effect of aromatherapy and distraction on pediatric venipuncture pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 3 to 8 years
Family and child consent to participate in the study
Exclusion criteria:
Children with asthma or allergies to aromatherapy
Suffering from mental retardation
Receive painkillers before venipuncture
Inability to communicate or lack of full consciousness
Age
From 3 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples with non-probability method available (easy) are selected from the pediatric ward of Ali Ibn Abitaleb Hospital in 1398 and meet the inclusion criteria. The samples are also assigned to the groups by permutation-class randomization method so that in addition to randomization of individuals between groups, they are also matched in terms of gender and age. There are three groups in this intervention. One control group, 2 aromatherapy groups and 3 doll groups. There are 6 permutations for numbers 1 to 3. Each case is assigned a number from 1 to 6, and by using the lottery until the sample size is completed, different permutation modes are selected and classified into groups based on being a boy or a girl and age under 5 years or over 5 years.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences and Health Services
Street address
Zahedan University of Medical Sciences, Janat Blvd
Intervention group 1: Diverting using a red hat doll, the intervention will be performed for 3 minutes before the venous catheter is placed in the venipuncture room, and the distraction will continue until the end of the venous catheter placement, so that the researcher with the doll's hand Move the red hat and talk to the child in the language of the doll and play with him (puppetry).
Category
Other
2
Description
Intervention group 2: Aromatherapy with lavender, in this method, children for 20 minutes, 5 drops of 2% lavender essential oil prepared by Barij Essential Oil Pharmaceutical Company with ISO 9001 quality certificate and ISO / IEC 117025 standard poured on a 10 * 10 napkin They inhale the straps attached to the collar of their shirts and are then transported to a venipuncture room.
Category
Other
3
Description
Control group: In the control group, only pain was measured 10 minutes after venipuncture and no distraction and aromatherapy were performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Abne Abitaleb Hospital affiliated to Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Shiva Karimi Afshar
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
shivakarimiafshar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Normohammad Bakhshany
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
shivakarimiafshar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shiva Karimi Afshar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
shivakarimiafshar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shiva Karimi Afshar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
shivakarimiafshar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shiva Karimi Afshar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
shivakarimiafshar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available