Determining the effect of Benson relaxation and non-verbal music on mothers anxiety before cesarean surgery in selected hospitals in Karaj
Design
A clinical trial with a control group, with parallel groups, not blinded, with a sample size of 70 people that by simple randomization, they are divided into intervention and control groups.
Settings and conduct
The research environment is selected hospitals in Alborz province in which cesarean section is performed and includes Bahonar, Rajaei, Kamali, Sarollah and Alborz hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: full consciousness; ability to read and write; experience of first cesarean section; having a doctor's license.
Non- Inclusion criteria: unwillingness to cooperate; hearing impairment; mental and anxiety disorders; history of chronic pain and cancer; experience of stress in the last 3 months; Use of herbal or chemical sedatives.
Intervention groups
In the intervention group, one hour before the cesarean section, Benson's muscle relaxation recorded in tape will be played
through the Walkman and headphones for 20 minutes, and the subjects will be asked to perform relaxation according to the instructions in the tape. In the control group, non-verbal music will be played for 20 minutes via Walkman and the headphone
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190408043199N1
Registration date:2020-08-29, 1399/06/08
Registration timing:retrospective
Last update:2020-08-29, 1399/06/08
Update count:1
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
sedigheh nosrati Abarghoee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3434 9805
Email address
pajohesh3584@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Benson relaxation and non-verbal music on anxiety in pregnant mothers before cesarean section
Public title
Relaxation effect on anxiety in mothers before cesarean section
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Ability to read and write
Experience the first cesarean section
Have a doctor's license
Exclusion criteria:
Reluctance to cooperate
Hearing impairments
Mental and anxiety disorders
History of chronic pain and cancer
Experience stress in the last three months
Use of herbal or chemical sedatives
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into two groups of intervention and control by simple randomization method and with the help of random number table. The randomization unit is individual.
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 Alborz University of Medical Sciences
Street address
Deputy of Research and Technology-Alley Safariyan-45 meters Golshahr-Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
ABZUMS.REC.1397.163
Health conditions studied
1
Description of health condition studied
Scary anxiety before section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before surgery and immediately after the intervention
Method of measurement
Spielberger Situational Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the intervention group, one hour before cesarean section, the Benson muscle relaxation method will be recorded on a tape through a walkman and headphones for 20 minutes and people will be asked. Perform the relaxation procedure according to the instructions in the bar.
Category
Lifestyle
2
Description
In the control group, non-verbal music will be played for 20 minutes through a walkman and headphones.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
kamali hospital
Full name of responsible person
sedigheh nosrati abarghoee
Street address
Kamali Educational Center- Kamali St-Shohada Square-Shahid Beheshti Street- Karaj City
City
karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
pajohesh3584@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Deputy of Research and Technology-Alley Safariyan-45 meters Golshahr-Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3176
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Sedigheh Nosrati Abarghoee
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Sixth Golestan street; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3147734568
Phone
+98 26 3434 9807
Email
pajohesh3584@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Sedigheh Nosrati Abarghoee
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Sixth Golestan street; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3147734568
Phone
+98 26 3434 9805
Email
pajohesh3584@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Sedigheh Nosrati Abarghoee
Position
Non-faculty
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Sixth Golestan street; Baghestan boulevard
City
Karaj
Province
Alborz
Postal code
3147734568
Phone
+98 26 3434 9805
Email
pajohesh3584@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