The objective of this clinical trial is to compare the effects of bensone relaxation and rhythmic breathing on anxiety of patient candidates mastectomy.
The study population will be women undergoing mastectomy in the Emam Khomeini hospital. Ninety participants were randomly assigned to of Benson relaxation and rhythmic breathing, or control groups. In the Benson Relaxation group after providing quiet environment will be taught this relaxation to the patient and she will be asked to follow 2 times relaxation for 20 minutes in the supine position with an 2-hours intervals. in Rhythmic breathing group after training, participants will be asked as well as Benson relaxation follow 2 times Rhythmic breathing for 20 minutes Sitting in a comfortable position With an 2-hours interval. The control group will not receive any type of intervention but only like two Intervention groups, cognitive and somatic anxiety questionnaire will be completed by the participants at first meeting, in the night of intervention, tomorrow morning and post-operative.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042017350N1
Registration date:2014-05-05, 1393/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Fatemeh Sadeghiyan
Name of organization / entity
Tehran University of Medical Sciences,nursing and midwifery university
Country
Iran (Islamic Republic of)
Phone
+98 913 236 7544
Email address
f-sadeghiyan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology Tehran university of Medical Science.Ghods street. Keshavarz blvd.Tehran.Iran
Expected recruitment start date
2014-04-22, 1393/02/02
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Two Tecchniques of Anxiety Management for Mastectomy Candidates: Benson’s Relaxation and Rhythmic Breathing
Public title
Impact of relaxation on anxiety resulting from breast surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: female gender; age 20 to 60 years old; no trouble hearing; lack of mental illness known; not taking anti-anxiety drugs; not suffering from substance abuse; unfamiliarity with the same period of benson relaxation or rhythmic breathing in the intervention group; lack of musculoskeletal disorders; not suffering from respiratory disorders such as asthma; ability to communicate in Persian language.
Exclusion criterion: not wanting to continue working in the research study at any time.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Central building, Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Postal code
1417614411
Approval date
2013-05-25, 1392/03/04
Ethics committee reference number
92/د/130/341
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F48.0
ICD-10 code description
anxiety:stat
Primary outcomes
1
Description
Anxiety
Timepoint
Befor intervention, the night after intervention, tomorrow morning- after oprationan and after consciousness mastectomy surgery
Method of measurement
Cognitive Somatic Anxiety Questionnare
Secondary outcomes
empty
Intervention groups
1
Description
1-benson relaxation: the researcher to patient education that In the best situation in which to feel comfortable being in bed,Close her eyes,then It is a word that always reminds him peace select,Start breathing deep and regular,inspiration from Mouth and Expiration through the nose and During each exhale to repeat that's word.The tip of the toes, relax her muscles and continues this to upper body.Then twice with an interval of 2 hours each time, perform 10-20 minutes of besnson relaxation.
Category
Prevention
2
Description
2-rhythmic breathing:Patient sitting on a chair with closed eyes, neck and chest raised and puts her feet on the ground quite a stretch.then start to inspiration and expiration: in the inspiration the chest and abdomen fills of the air, After the deepest inspiration will be empty her chest.The same procedure is done with a focus on breathing in different positions.Then twice with an interval of 2 hours each time, perform 10-20 minutes of rhythmic breathing.
Category
Prevention
3
Description
3-control: receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital, Imam Khomeini Cancer Institute
Full name of responsible person
Dr. Zohreh Parsa Yekta, Associate of professor
Street address
Imam Khomeini hospital, End of Keshavarz Boulevard
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Yunesiyan
Street address
The Sixth Floor, Deputy of Research and Technology, Ghods street, Keshavarz blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?