Comparison of the Effect of Progressive Muscle Relaxation Technique and Aromatherapy with Damask Rose on Anxiety, Stress and Depression in General Surgical Candidates
Compare the effect of relaxation and aromatherapy on the mental health of candidates for surgery
Design
Clinical trials with community based and pragmatic control group, with parallel groups, randomized
Settings and conduct
This intervention will be carried out in the surgery department of Kashani Hospital in Shahrekord. In the relaxation group, the questionnaire was completed by the researcher first. Then, on the day of the practice, the researcher selected his samples by referring to the general surgery department and trained the relaxation by transferring the patient to the place intended for training progressive muscle relaxation. . Then, one hour before the patient goes to the operating room, the patient listens with a handsfree audio file in the presence of the researcher.
In the scent group, the questionnaire is first completed by the researcher. Then on the day of surgery one hour before going to the operating room, 3 drops of essential oil from the flower of Mohammadi are poured onto a tissue and pinned on the pillow of patients. There is no intervention in the control group.
Participants/Inclusion and exclusion criteria
The criteria for entering:
1. Patient of elective surgery
2- At least 18 and up to 60 years old.
3. Not having surgery history
4. The desire to cooperate
5- Hospitalization in the surgery section of the day before surgery
Exit criteria :
1. Acute pain
2. Use of benzodiazepines
3. History of allergy
4- Death
Intervention groups
Progressive Muscle Relaxation Group
Scent Therapy Group
control group
Main outcome variables
Depression
Anxiety
Stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181122041720N1
Registration date:2018-12-06, 1397/09/15
Registration timing:prospective
Last update:2018-12-06, 1397/09/15
Update count:0
Registration date
2018-12-06, 1397/09/15
Registrant information
Name
Shirin Madadkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2382
Email address
shirinmadadkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Progressive Muscle Relaxation Technique and Aromatherapy with Damask Rose on Anxiety, Stress and Depression in General Surgical Candidates
Public title
Comparison of the Effect of Progressive Muscle Relaxation Technique and Aromatherapy with Damask Rose on Anxiety, Stress and Depression in General Surgical Candidates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. The patient is on the list of elective general surgery (hernia and cholecystectomy).
2- Having at least 18 and up to 60 years old.
3- No history of surgery.
4- The desire to cooperate in research
5- Hospitalization in the surgery part of the day before surgery
Exclusion criteria:
1. Acute pain at the time of completing the questionnaire
2. Use of benzodiazepines and tranquillizers and opiates
3. History of allergy to plants
4. Death of the sick
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, the participants were randomly assigned to three groups using computer software using three blocks. To hide the assignment, the type of intervention was determined based on the blocking on the paper and placed inside the opaque packs of the sequential numbering. Envelopes were opened in the order of participation of the participants, and the specified intervention was implemented for the participants.
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 Shahrekord University of Medical Sciences
Street address
Rahmatieh Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2018-03-02, 1396/12/11
Ethics committee reference number
SKUMS.REC.IR.1396.264
Health conditions studied
1
Description of health condition studied
Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Depression
Timepoint
Before intervention and immediately after intervention
Method of measurement
DASS questionnaire
2
Description
Anxiety
Timepoint
Before intervention and immediately after intervention
Method of measurement
DASS questionnaire
3
Description
Stress
Timepoint
Before intervention and immediately after intervention
Method of measurement
DASS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the progressive muscle relaxant group, the questionnaire was completed by the researcher and the patient's vital signs were recorded by the researcher and recorded in the form. The intervention is done so that on the day of the work of the researcher, referring to the general surgery department of Kashani Hospital in Shahrekord, and reviewing the surgical list, select the samples and transferring the patient to the place intended for training progressive muscle relaxation, He teaches every person face-to-face and practical relaxation. Then, one hour before the patient goes to the operating room, by providing a completely quiet environment and minimizing environmental stimuli, such as low light of the room, and limiting travel to the patient's room, the patient through the hands-free program of progressive muscle relaxation audio in the presence of The researcher listens.In this method, the patient is placed in a comfortable comfortable bed. Closes his eyes and, as far as possible, stays in a state of relaxation and concentrates all his attention on his breathing. 5 times deep breath and each time the lungs completely fill the air and gently empty. Meanwhile, in his mind, he thinks relaxed and relaxed. After this stage, the patient should have muscle contraction and expansion for 14 muscle groups, including facial muscles (forehead, eyelids, jaws and lips), neck muscles, fingers and palms, forearm, arm, shoulder, back, Lumbar, chest, abdomen, seat, thighs, legs and legs. Each muscle contraction is 5 seconds and its expansion lasts 10 seconds. During the procedure, the patient should focus on the muscles that rigidify and relax. At the end, the patient relaxes his entire body, breathes deeply and lets his eyes slowly open and return to normal. The patient does this technique for 20 minutes (1). Then, the DASS questionnaire and the vital signs registration form are completed by the researcher.In the scent group, the questionnaires are first completed by the researcher and the patient's vital signs are recorded by the researcher and recorded in the relevant form. The intervention is then done on the day of operation one hour before going to the operating room, three drops of 10% essential oil from the flower of Mohammadi (made in Barij Essen, Kashan) will be poured onto a tissue paper and pinned on the pillow of the patients. And patients are asked to smell it for 20 minutes. According to previous studies, a tissue paper impregnated with three drops of essential oil of 10% may be produced for 12 hours (8 and 1). After the intervention, the DASS questionnaire and the vital signs registration form are completed by the researcher.Sampling in groups is done simultaneously.
Category
Other
2
Description
Control group: Control group: There is no intervention in the control group and all routine nursing care before the operation includes the patient's NPO, the location of the operation and the completion of the patient's case. In this group, the questionnaires were completed only one hour prior to going to the operating room and vital signs are recorded
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Shirin Madadkar
Street address
Nursing Street, Ayatollah Kashani Hospital
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816778915
Phone
+98 38 3226 4825
Email
Kashani@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Shahrekord University of Medical Sciences
Full name of responsible person
dr.Kamal Solati
Street address
Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Street, Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
Shirinmadadkar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Street, Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Email
shirinmadadkar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Research Deputy of Shahrekord University of Medical Sciences
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Street, Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816759815
Phone
+98 38 3226 4825
Email
shirinmadadkar@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
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