The Combined Effect of Rhythmic Breathing and Aromatherapy on the Severity of Pain and the Level of Anxiety in Patients with unstable Angina
Design
This study will be a randomized clinical trial type, two groups (one intervention group and one control group) will be used to allocate the samples to the study groups randomly. Then to determine https://www.sealedenvelope.com: the required random blocks and its sequence from the website
will be used.
Settings and conduct
The research environment will be the CCU department of hospitals in Zanjan province
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 30 to 70 years old
Being fully conscious
Pain above 3.
Anxiety over 30.
Exit criteria : .
People who have previously undergone anginayogurt.
People who have diabetes.
People who have drug and psychoactive addiction
People with known mental health problems
Intervention groups
Group of rhythmic breathing and aromatherapy with rosemary essential oil (group A) - control group with distilled water (group B)
Main outcome variables
Anxiety, pain, vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061864N1
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Sahar Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 0832
Email address
s.nouri.zanjan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Combined Effect of Rhythmic Breathing and Aromatherapy on the Severity of Pain and the Level of Anxiety in Patients with unstable Angina
Public title
The Combined Effect of Rhythmic Breathing and Aromatherapy on the Severity of Pain and the Level of Anxiety in Patients with unstable Angina
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 70 years old
Being fully conscious
Having a Pain score above 3
Having a Anxiety score above 30
Exclusion criteria:
People who have previously undergone angiography
People who have diabetes
People who have drug and psychoactive addiction
People with known mental health problems
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
Random permutation block design of two groups with blocks of four will be used to randomly assign the samples to the study groups. Then to determine the required random https://www.sealedenvelope.com blocks and its sequence from the website
will be.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Unstable angina pectoris patients hospitalized in intensive care units
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
Anxiety level on the visual analogue scale of anxiety
Timepoint
The anxiety level will be measured immediately before the intervention, 60 minutes , 120 minutes, 180 minutes, and 240 minutes after the intervention.
Method of measurement
Visual analog scale of anxiety
2
Description
Pain intensity is on a visual analog scale
Timepoint
Pain intensity will be measured immediately before the intervention, 60 minutes, 120 minutes, 180 minutes, and 240 minutes after the intervention.
Method of measurement
Visual analog pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group are asked to perform rhythmic breathing for 20 minutes, once every 5 minutes and each time for 1 minute, a total of four times in 20 minutes according to the taught method. 10 by 10 is poured on simple gauze and it is attached to the collar of patients' shirts with plastic pins, and the patients are asked to inhale the scent for one hour, and after one hour, the same pads are recharged with three more drops and this is done. It is repeated for the next hour. In other words, the intervention was 3 hours, and the pads are charged every hour, that is, three drops per hour, and a total of three hours of intervention, 4 hours of total study time, and 9 drops of essential oil for each patient.It is used and the scent is purchased from a reputable company called Barij Essan
Category
Treatment - Drugs
2
Description
Control group: In terms of receiving painkillers and nitrates, the control group will be compared to the control and intervention groups, and in the control group, only the usual nursing care will be performed, and distilled water will be used as aromatherapy in the control group, and the patients will be asked to drink distilled water. inhale for one hour, and after one hour, the same pads are charged again with three more drops, and this is repeated for the next hour, in other words, the intervention is 3 hours, and the pads are charged every hour. That is, three drops per hour and a total of three hours of intervention and 4 hours of total study time and 9 drops of distilled water are used for each patient.