This study will aim to compare the effectiveness of aromatherapy and music on sleep quality in hemodialysis patients.
Design
Unblinded, parallel-group, randomized, crossover clinical trial on 60 patients undergoing hemodialysis. Simple randomization using sealed envelopes will be used for randomization.
Settings and conduct
For patients in the music group, silent music will be played for 10 minutes right when the patient is in bed, using a smartphone without headphones or a headset for one month. For patients in the aromatherapy group, lavender scent will be inhaled in the form of a small gauze soaked in lavender essential oil, which will be pinned to the patient's collar right at the beginning of going to bed, for one month. Then, both groups will have a washout for one month, and then the intervention used by the patients will be changed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18, history of at least 3 months of hemodialysis, score of 5 or higher on the Pittsburgh Sleep Quality Questionnaire, and having a smartphone (yours or a partner living with you) to transfer the desired music file.
Exclusion criteria: Having a smell problem (olfactory health test with lemon juice), having a known allergy to lavender, having a history of addiction or dependence on sleeping/tranquilizing drugs, and having a history of alcohol or drug addiction
Intervention groups
The one intervention group received aromatherapy (pure lavender essential oil; 100%). The latter intervention group received selected music (Baran Eshghe by Naser ChashmAzar) in accordance with Iranian culture.
Main outcome variables
Patients' sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N17
Registration date:2025-08-12, 1404/05/21
Registration timing:prospective
Last update:2025-08-12, 1404/05/21
Update count:0
Registration date
2025-08-12, 1404/05/21
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-16, 1404/05/25
Expected recruitment end date
2025-11-16, 1404/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Aromatherapy and Music on the sleep quality in hemodialysis patients
Public title
Comparison of the effects of Aromatherapy and Music on the sleep quality in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
History of at least 3 months of hemodialysis
Score of 5 or higher on the Pittsburgh Sleep Quality Questionnaire
Having a smartphone (yours or someone you live with) to transfer the desired music file
Exclusion criteria:
Having a smell problem (olfactory health test with lemon juice)
Having a known allergy to lavender
Having a history of addiction or dependence on sleeping/tranquilizing drugs
Having a history of alcohol or drug addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples (to two experimental groups) will be done by simple random method using sealed envelopes. 60 envelopes with one of the letters A or M in them (30 envelopes each) will be prepared, and the selection of the envelope will be done randomly by the patients. In this method, the letter A represents the aromatherapy group, and the letter M represents the music group. In this way, the number of samples of both groups will be random and equal.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2025-07-21, 1404/04/30
Ethics committee reference number
IR.SEMUMS.REC.1404.110
Health conditions studied
1
Description of health condition studied
Sleep quality in hemodialysis patients
ICD-10 code
F 51.0
ICD-10 code description
بیخوابی غیر ارگانیک
Primary outcomes
1
Description
Sleep quality
Timepoint
In four stages: at the beginning of the study, one month after the initial intervention, after the washout period, and at the end of the study.
Method of measurement
Sleep quality will be measured using the Pittsburgh Sleep Quality Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For patients in the music group, the intervention includes playing a wordless piece of music (Rain of Love by Naser Chashm Azar) for 10 minutes every night for a month, right when the patient has just gone to bed and is ready for their night's sleep. This will be done using a smartphone and without the use of headphones or hands-free devices, in the form of direct audio streaming into the space.
Category
Prevention
2
Description
Intervention group: For patients in the aromatherapy group, the intervention includes the use of pure (100%) lavender essential oil provided by Zardband Company along with medical gauze and a pin that will be provided to the patients. Patients are asked to pour 3 drops of the essential oil on a small piece of medical gauze (2 x 2 cm) every night before going to bed for a month, then pin the gauze soaked in the essential oil to their collar, breathe normally throughout the night, and remove it from their collar in the morning after waking up.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شهید دکتر رهنمون یزد
Full name of responsible person
Hassan Babamohamadi
Street address
Shahid Dr. Rahnemoon Hospital, Farrokhi Street, Yazd
City
Yazd
Province
Yazd
Postal code
3513138111
Phone
+98 35 3626 0001
Email
babamohammady2007@gmail.com
Web page address
https://rahnemoon.ssu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Vafaei
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
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
Not applicable
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