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Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis

Protocol summary

Study aim
Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis
Design
The clinical trial has 4 groups on 80 patients without blinding, and the days of the intervention are randomized.
Settings and conduct
This study was conducted in the dialysis department of Mehr Madar Hospital, Four groups of aromatherapy, virtual reality, combined group and control group. In the aromatherapy group, 3 drops of essential oil were dripped on the cloth and placed inside the mask, and in the virtual reality group, relaxing images were played using virtual reality glasses. And in the combined group, two interventions were performed together.
Participants/Inclusion and exclusion criteria
- Not having physical problems, mental illness, smell sensitivity, not taking sleeping pills - Allergy to essential oil, death
Intervention groups
Four groups of aromatherapy, virtual reality, combined group and control group. In the aromatherapy group, 3 drops of essential oil were dripped on the cloth and placed inside the mask, and in the virtual reality group, relaxing images were played using virtual reality glasses. And in the combined group, two interventions were performed together.
Main outcome variables
Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221225056922N1
Registration date: 2023-01-04, 1401/10/14
Registration timing: retrospective

Last update: 2023-01-04, 1401/10/14
Update count: 0
Registration date
2023-01-04, 1401/10/14
Registrant information
Name
Fahime Heyrati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5254 7480
Email address
heyratifahime1364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-03-30, 1401/01/10
Actual recruitment start date
2022-02-20, 1400/12/01
Actual recruitment end date
2022-03-30, 1401/01/10
Trial completion date
2022-03-30, 1401/01/10
Scientific title
Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis
Public title
Comparison of virtual reality and the effect of rose scent on onexiety , quality sleep and happiness hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- Satisfaction and willingness to participate in research- Having at least 3 months of hemodialysis experience- Not having hearing, vision and smell problems- No mental illness or accident in the past 6 years- Not having debilitating diseases (dementia and Parkinson's)- Not sensitive to smell- Not using sleeping and anti-anxiety drugs or other therapeutic measures such as using herbal essences during the intervention period
Exclusion criteria:
- Death or absence of a session in intervention sessions- Sensitization to essential oil- Refusal to continue participating in the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 73
Randomization (investigator's opinion)
Randomized
Randomization description
The selected community was divided into four groups: aroma therapy (B), virtual reality (C), combined group (aroma therapy and virtual reality) (D) and control group (A). Dialysis was randomized and an intervention was randomly performed every day.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study was done in 4 groups and comparing the groups with each other

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
third alley on the right , 39 Imam Khomeini Street
City
Torbat jam
Province
Razavi Khorasan
Postal code
9591783753
Approval date
2022-01-29, 1400/11/09
Ethics committee reference number
IR.BUMS.REC.1400.360

Health conditions studied

1

Description of health condition studied
Anxiety, happiness, sleep quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score in the Spielberger questionnaire
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Spielberger Anxiety Questionnaire

2

Description
Sleep quality score in the Pittsburgh Questionnaire
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Pittsburgh Questionnaire

3

Description
Happiness score in the Oxford Happiness Questionnaire
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Oxford Happiness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Aromatherapy group, 3 drops of rare rose essential oil (rose water) with a concentration of 25%, which is readily available in the market, was dripped on absorbent cloth with a dropper and placed inside the patient's mask (due to the conditions of Corona). and the patient was asked to breathe normally for 15 minutes due to the possibility of spreading the aroma on the mask and reducing the lasting effects of the aroma, after the duration of aromatherapy the patients' masks were changed. The intervention was done once a week for four weeks
Category
Rehabilitation

2

Description
Intervention group: Intervention group: virtual reality group, in the virtual reality group, using 3D glasses, calming images of the patients' favorite scenes were played for 15 minutes. This was done once a week for four weeks.
Category
Rehabilitation

3

Description
Intervention group: Intervention method: the combined group (aromatherapy and virtual reality) of the scent of rare rose essence (rose water) with a concentration of 25%, which is ready in the market, was dripped 3 drops with a dropper on an absorbable cloth and placed inside the patient's mask (to the reason for the condition of Corona) was placed and the patient was asked to breathe normally for 15 minutes and at the same time, using 3D glasses, soothing images of the patients' favorite scenes were played for 15 minutes. The intervention was once a week for four weeks. Done.
Category
Rehabilitation

4

Description
Control group: Control group: no intervention was performed during the study period, but after collecting the questionnaires at the end of the intervention, for ethical reasons, according to the wishes of the patients in this group, one of the interventions was performed in one session.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis Department of Mehr Madar Hospital in Torbat Jam
Full name of responsible person
Fahime Heyrati
Street address
the third alley on the right,Imam Khomeini 39
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9591783753
Phone
+98 51 5254 7480
Email
heyratifahime1364@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ahmad Nasiri
Street address
University of Medical Sciences,Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5700
Email
nasiriahmad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
1
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
Birjand University of Medical Sciences
Full name of responsible person
Fahime Heyrati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The third alley on the right,Imam Khomeini 39
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9591783753
Phone
+98 51 5254 7480
Email
heyratifahime1364@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahime Heyrati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The third alley on the right,Imam Khomeini 39
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9591783753
Phone
+98 51 5254 7480
Email
heyratifahime1364@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahime Heyrati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The third alley on the right,Imam Khomeini 39
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9591783753
Phone
+98 51 5254 7480
Email
heyratifahime1364@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 further information
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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