Protocol summary

Study aim
Determining the effect of aromatherapy with rose water and peppermint on pain and anxiety caused by abdominal surgery in children aged 6 to 12 years.
Design
The clinical trial has fragrance groups with rose water, peppermint and control group. The sample size was estimated to be 32 people in each group. Taking into account the 10% loss of the studied samples, the final volume in each group will be 36 people. Allocation of samples in groups is done using random block method. It is used in order to equalize the distribution of confounding variables of gender and level of anxiety before the intervention.
Settings and conduct
Ali Asghar Children's Center in Tehran, data collection tools in this research include the demographic information collection form, FLACC pain behavioral response checklist, and Hamilton's anxiety questionnaire. The children will be placed in one of the groups with the scent of rose water, scent with peppermint and the control group. Allocation of the samples in the groups is done using random block method. In the intervention groups, 2 drops of rose oil or peppermint essence will be poured on the pad soaked in normal saline and will be attached to the collar of the child's clothes for half an hour immediately after removing the pad. , the child's pain and anxiety will be measured, in the control group, a pad soaked in normal saline without fragrance will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child is 12-6 years old; performing elective abdominal surgery
Intervention groups
Rose scent, peppermint scent and control group
Main outcome variables
Heart rate, breathing and blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230409057861N1
Registration date: 2023-11-08, 1402/08/17
Registration timing: prospective

Last update: 2023-11-08, 1402/08/17
Update count: 0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Zahra Nadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 5828 2618
Email address
pr.lums@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rosa and peppermint scents on postoperative pain and anxiety in 6-12 years children with abdominal surgery
Public title
Comparison of rosa and peppermint scents on postoperative pain and anxiety in children with abdominal surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having both parents Children should be 6 to 12 years old The child should be awake before the surgery Always accompany the child and only the mother Verbal consent of the child to participate in the stud Ability of child and mother to communicate verbally Performing elective abdominal surgery in children Presence of the child and mother at least 12 hours before and 18 hours after the operation in the ward
Exclusion criteria:
Prolonging surgery in the operating room Having complications during surgery and complications of anesthesia (severe hypothermia) The occurrence of unwanted complications after surgery such as bleeding, opening of the surgical site, etc. Need for ICU after surgery Child's and mother's unwillingness to continue the research Moving the child to another department/hospital Discharge of children from the hospital with personal consent the impossibility of the parent being with the child during the entire period of hospitalization for any reason (illness, personal problems, etc Disruption in completing the anxiety questionnaire by the mother Occurrence of symptoms of allergy to scents in the child or mother during the study Patients with acute problems and undergoing emergency surgeries The child has multiple surgical incisions Performing major abdominal surgeries (volvulus, laparotomy obstruction) and multiple incisions History of surgery or hospitalization in the child Physical and metabolic diseases such as diabetes and phenylketonuria in children History of allergic rhinitis in child and mother History of respiratory, skin and dermatitis sensitivity in child and mother The presence of chronic pain in children Taking painkillers or sedatives during 24 hours before abdominal surgery by the child Taking nerve medication or suffering from nerve diseases such as anxiety and depression, hyperactivity and autism Use of hypnotics, sedatives or benzodiazepines by the child within a week before the start of the intervention. Use of systemic painkillers such as ibuprofen and acetaminophen before surgery in children Use of complementary medicine methods (aromatherapy, etc.) for the child and parents for a week before the intervention. A child suffering from mental retardation Obvious cognitive, psychological or physical problems in parents and children
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in groups is done using random block method. In order to equalize the distribution of gender confounding variables and the level of anxiety before the intervention, first classes based on these variables as described by girl/boy and mild (≥17)/moderate (18-24)/severe (25-30)/very severe anxiety (<30) are created and then they are balanced in the studied groups by random block method
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is one-sided blind and the statistical consultant is blind. After collecting the data without identifying the intervention and control groups, descriptive statistics are used to describe the data, calculating central and dispersion indices for quantitative variables and frequency and percentage for qualitative variables.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Moalem ave
City
Khoram Abad
Province
Lorestan
Postal code
6813833946
Approval date
2023-02-04, 1401/11/15
Ethics committee reference number
IR.LUMS.REC.‪1401.302

Health conditions studied

1

Description of health condition studied
Abdominal surgery
ICD-10 code
Z40.8
ICD-10 code description
Encounter for other prophylactic surgery

Primary outcomes

1

Description
Percentage of children candidates for abdominal surgery
Timepoint
Hospitalization time in the ward and before aromatherapy, immediately after the operation and at half an hour, 3, 6, 9, 12 and 16 hours after the operation
Method of measurement
Data collection tools in this research include the demographic information collection form, FLACC pain behavioral reaction checklist, and Hamilton's anxiety questionnaire.

Secondary outcomes

1

Description
Blood oxygen saturation percentage
Timepoint
at the time of entering the ward and before aromatherapy, and at half, 3, 6, 9, 12 and 16 hours after the operation
Method of measurement
Pulse oximetry device

Intervention groups

1

Description
Intervention group: In the intervention groups, 2 drops of rose essential oil or peppermint will be poured on a pad soaked in normal saline and will be attached to the collar of the child's clothes for half an hour. Immediately after removing the pad, the child's pain and anxiety will be measured. In the control group, A pad soaked in unscented normal saline will be used. The anxiety of the units studied by the researcher and assistant researchers one hour after the child's hospitalization before receiving the scent and 8 hours after hospitalization, 9, 12 and 16 hours after the operation and receiving the scent half an hour before the above hours with the Hamilton tool through an interview with the mother by the researchers will be measured. Also, children's pain will be measured using Flak tool upon entering from the operating room to the ward before giving the aroma at half, three, six, nine, twelve and sixteen hours after the operation and receiving the aroma for half an hour by the researcher and assistant researchers.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Childrens Hospital
Full name of responsible person
Fatemeh ghasemi
Street address
Zafar Ave, Modares Highway
City
Tehran
Province
Tehran
Postal code
1411863887
Phone
+98 21 2222 2041
Email
aliasghar@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh ghasemi
Street address
Lorestan univercity of medica scieces, anvoshirvan rezaei square, moalem ave
City
Khoram abad
Province
Lorestan
Postal code
6895113132
Phone
+98 66 3312 0169
Email
ghasemi2211156@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
50
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra nadri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam khomeyni
City
Aleshtar
Province
Lorestan
Postal code
6895113435
Phone
0098 58282618
Email
Z.nadri77@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Nadri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Golshan Alley 7, Yadgar Imam Square, Imam Khomeini Ave
City
Aleshtar
Province
Lorestan
Postal code
6895113435
Phone
0098 58282618
Email
Z.nadri7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Zahra Nadri
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golshan Alley 7, Yadgar Imam Square, Imam Khomeini Ave
City
Aleshtar
Province
Lorestan
Postal code
6895113132
Phone
+98 66 2858 2618
Email
Z.nadri77@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
The result was unclear due to the reason
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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