Investigation of the effect of aromatherapy with lavender essential oil on the amount of odor, quality of sexual life and ostomy adjustment in patients with permanent colostomy
Determining the effect of ear acupressure on itching, dry mouth and fatigue of patients undergoing hemodialysis in centers affiliated to kerman university of medical sciences.
Design
This study is a clinical trial with two groups, no blinded and randomized, with 25 patients in each group. The randomization method will be simple and stratified, and a stratum will be formed based on gender.
Settings and conduct
This study will be conducted at the ostomy clinic of bahonar hospital in kerman. Aromatherapy intervention will be performed for a duration of one month in the intervention group. The amount of odor, quality of sexual life and ostomy adjustment will be measured before and after the intervention in both the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least 3 months have passed since colostomy insertion; Persons with over 18 years of age; Persons with Permanent colostomy; Living in Kerman city; Complaining about the unpleasant smell of the ostomy bag; Changing or washing the colostomy bag at least once a day; having a sexual partner
Non inclusion criteria: Using any product other than lavender essential oil in the ostomy bag؛ Staying in a city other than Kerman, having late ostomy complications, Patients with mental disorders, Treated with chemotherapy and radiation therapy, Allergy to lavender essential oil, Reluctance to cooperate
Intervention groups
The intervention involves using lavender essential oil for the intervention group by applying it inside the colostomy bag. Over one month, participants spray 3 puffs (0.5 mL) of lavender oil into the bag at each change or wash, thoroughly covering the internal surface. The control group continues their usual colostomy care and diet without any intervention.
Main outcome variables
Amount of Odor; Quality of Sexual Life; Colostomy Adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N19
Registration date:2024-06-05, 1403/03/16
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of aromatherapy with lavender essential oil on the amount of odor, quality of sexual life and ostomy adjustment in patients with permanent colostomy
Public title
Investigation of the effect of aromatherapy with lavender essential oil on the amount of odor, quality of sexual life and ostomy adjustment in patients with permanent colostomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 months have passed since colostomy insertion
Persons with over 18 years of age
Persons with Permanent colostomy
Living in Kerman city
Complaining about the unpleasant smell of the ostomy bag
Changing or washing the colostomy bag at least once a day
Having a sexual partner
Exclusion criteria:
Using any product other than lavender essential oil in the ostomy bag
Staying in a city other than Kerman
having late ostomy complications such as prolapse, parastomal hernia, stricture, obstruction, damage to the skin around the stoma, fistula, and metabolic complications
Patients with mental disorders
Treated with chemotherapy and radiation therapy
Allergy to lavender essential oil
Reluctance to cooperate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be based on the identifiable number of ostomized patients and their demographic information, which will be categorized in a simple and stratified manner. One stratum will be formed based on gender to ensure, to the extent possible, an equal number of men and women due to the potential differences in the quality of sexual life questionnaire between females and males.
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.KMU.REC.1403.054
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
Z93.3
ICD-10 code description
Colostomy status
Primary outcomes
1
Description
The Amount of Odor
Timepoint
It will be measured before the intervention, immediately after the intervention (at the end of the fourth week).
Method of measurement
General Labeled Magnitude Scale (GLMS)
2
Description
Quality of Sexual Life
Timepoint
It will be measured before the intervention, immediately after the intervention (at the end of the fourth week).
Method of measurement
Sectuality Quality of Life-Female (SQOL-F), Sextuality Quality of Life-Male (SQOL-M )
3
Description
Colostomy Adjustment
Timepoint
It will be measured before the intervention, immediately after the intervention (at the end of the fourth week).
Method of measurement
Ostomy Adjustment Inventory-23 (OAI-23)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment, 3 puffs (equivalent to 0.5 cc) of lavender essential oil will be sprayed into the bag at least three times a day, each time the colostomy bag is changed or washed.
Category
Other
2
Description
Control group: They will follow their routine colostomy care and diet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ostomy Clinic of Bahoner Hospital
Full name of responsible person
Batool Tirgari
Street address
Shahid Bahonar Hospital, Valiasr Blv
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
B_tirgari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research and Technology Kerman University of Medical Sciences
Full name of responsible person
DR Abedin Iranpour
Street address
No 2, Research and Technology Dept., Ibnsina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research and Technology Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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