Protocol summary
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Study aim
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Determining the effect of Benson relaxation and non-verbal music on mothers anxiety before cesarean surgery in selected hospitals in Karaj
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Design
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A clinical trial with a control group, with parallel groups, one-blind, with a sample size of 105 people, which are divided into three groups of Benson relaxation, non-verbal music and control by simple random assignment
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Settings and conduct
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The research environment is selected hospitals in Alborz province in which cesarean section is performed and includes Bahonar, Rajaei, Kamali, Sarollah and Alborz hospital.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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 non-verbal music will be played for 20 minutes via Walkman and the headphone. Control group participants receive only routine nursing care
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Main outcome variables
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Anxiety
General information
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Reason for update
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Add control group
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190408043199N1
Registration date:
2020-08-29, 1399/06/08
Registration timing:
prospective
Last update:
2022-01-01, 1400/10/11
Update count:
1
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Registration date
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2020-08-29, 1399/06/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-20, 1400/10/30
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Expected recruitment end date
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2022-04-19, 1401/01/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effect of Benson relaxation and non-verbal music on anxiety in pregnant mothers before cesarean section
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Public title
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Relaxation effect on anxiety in mothers before cesarean section
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
105
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants are randomly divided into three groups: Benson Relaxation, Music Therapy, and Control, using the card shuffle method. First, code A is given to the Benson group, code B to the music group, and code C to the control group. The letters A, B or C are then written on the cards and placed in the envelope. Each participant is then asked to choose one of the envelopes. Participants who choose A, B, or C enter the Benson, Music, and Control groups, respectively.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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A statistician who is blinded by a group assignment will perform the analysis using SPSS software
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-12, 1397/10/22
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Ethics committee reference number
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ABZUMS.REC.1397.163
Health conditions studied
1
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Description of health condition studied
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Scary anxiety before section
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Anxiety
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Timepoint
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Before surgery and immediately after the intervention
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Method of measurement
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Spielberger Situational Anxiety Inventory
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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In the non-verbal music group will be played for 20 minutes through a walkman and headphones.
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Category
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Lifestyle
3
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Description
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Control group: Participants in the control group only receive routine nursing care.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Karaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available