The effect of benson's relaxation technique on anxiety and stress before cesarean delivery in primiparous women
Design
clinical trial with two intervention and control groups and a volume of 60 samples
Settings and conduct
Research environment is maternity ward in imam hossein educational therapy center, affiliated to shahid beheshti university tehran It consists of 40 active beds.After obtaining the necessary permissions first, to select patients from both groups From afternoon the day before the operation The list of patients undergoing cesarean section surgery The next day will be referred And after obtaining satisfaction from the samples,Samples are based on paired and individual dates Will be allocated to intervention and control groups.In the Benson relaxation group units How to use the relaxation method They are taught Repeat it at least twice before surgery And in the control group routine care No relaxation method is done.
Participants/Inclusion and exclusion criteria
Criteria for entering :The originality of the samples - Candidates for cesarean samples - Having reading and writing skills - Full consciousness - Not having a history of psychiatric problems, seizures or epilepsy and severe heart failure approved by the doctor - Desire to attend relaxation sessions.
Non-entry criteria:
Patient's personal desire for not participating in the study
Use of sedative and anxiety medications
The candidate for normal delivery
Emergency cesarean section (non-elective)
High-risk pregnancy
Intervention groups
The intervention group is a group whose benson relaxation method runs on them.In the control group, routine care is performed without a relaxation method.
Main outcome variables
Providing comfort and satisfaction for patients; Assisting clinical nursing tasks; The Importance of anxiety and stress control ; Increased satisfaction of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170819035775N2
Registration date:2018-05-16, 1397/02/26
Registration timing:registered_while_recruiting
Last update:2018-05-16, 1397/02/26
Update count:0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
akram salmanzade
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 212218008392
Email address
ak.salmanzade@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson's relaxation technique on anxiety and stress before Cesarean delivery in primiparous women
Public title
effect of relaxation on anxiety and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for entering the study: - The originality of the samples - Candidates for cesarean samples - Having reading and writing skills - Full consciousness - Not having a history of psychiatric problems, seizures or epilepsy and severe heart failure approved by the doctor - Desire to attend relaxation sessions
Exclusion criteria:
The patient's personal desire to not participate in the study from the beginning
Use of sedative and anti-anxiety medications by the patient
The candidate for normal delivery of the patient
Maternal delivery by emergency cesarean section (non-elective)
High-risk pregnancy to confirm doctors
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
ethics committee of University of Social Welfare and Rehabilitation Sciences Tehran
Street address
Childhood stalemate,Student Boulevard, Evin,Tehran Town
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
ir.uswr.rec.1396.280
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress Score in Kuhn's Perceived Stress Questionnaire
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Using Cohen's Perceived Stress Questionnaire
2
Description
Anxiety Scale in Spielberger's Clear Anxiety Inventory
Timepoint
Before the intervention and one day after the intervention
Method of measurement
Using Spielberger's Clear Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Samples are based on paired and individual dates,in both groups, they will intervene and control.The number of samples was divided into two intervention and control groups includes 60 people which was 30 in the intervention group and 30 people in the control group . Both in the intervention group and in the control group to measure the severity of anxiety and stress of patients at the beginning of hospitalization anxiety and stress questionnaires are given to the patient who are overwhelmed.Then after admission in the intervene group how to use benson's relaxation method they are taught repeat it at least twice before surgery.In this study, the benson relaxation is as follows the patient is in the best condition in which he feels calm in the bed, closes his eyes, in this case, choose the word that always reminds her of calm and begin to breathe deeply and regularly and he's done the nose and expelled exhale through the mouth and in every exhale repeats the word in mind. At the same time, the muscles are released from the tip of your toes and this continues to the upper muscles of the body so that all muscles can reach full expansion. The patient maintains this condition for 10 to 20 minutes. Then it is recommended to the patient that avoid changing mode and displacement immediately after the end of the technique. Intervention for each patient twice and every 15 minutes it takes place at intervals of 2 hours.The day of operation in the intervention group again anxiety and stress questionnaires is given to complete the samples half an hour before entering the operating room.
Category
Other
2
Description
Control group: In the control group, routine care wards will be taken without any additional care by researcher and on behalf of the medical staff which is related to research and without a relaxation technique. In the control group, only the samples which includes 30 people received anxiety and stress questionnaires twice, one time before admission and once upon a day, and they complete half an hour before going to the operating room.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Medical Center, Educational and Therapeutic Center
Full name of responsible person
Akram Salmanzadeh
Street address
Martyr Madani Street,Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
47857
Phone
+98 21 7343 2527
Email
info@ehmc.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Childhood Death,Student Blvd, Evin,University of Social Welfare and Rehabilitation Sciences Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
a.salmanzade94@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Salmanzadeh
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Binjerabadi Alley, Behtashsefat street, Masoodieh
City
Tehran
Province
Tehran
Postal code
1787744641
Phone
+98 21 3345 2736
Email
a.salmanzade94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Salmanzadeh
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Binjerabadi Alley, Behtashsefat Street, Masoodieh
City
Tehran
Province
Tehran
Postal code
1787744641
Phone
+98 21 3345 2736
Email
a.salmanzade94@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Salmanzadeh
Position
Master's student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Binjerabadi Alley, Behtashsefat Street, Masoodieh
City
Tehran
Province
Tehran
Postal code
1787744641
Phone
+98 21 3345 2736
Email
a.salmanzade94@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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
pdf file informed consent form participation in research project
When the data will become available and for how long
Start the access period one year after the print results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Allow full use of the form
From where data/document is obtainable
Refer to email: a.salmanzade94@gmail .com
What processes are involved for a request to access data/document
After receiving the request via email within one to two weeks the form is sent to them.