Determining the effect of music on the self-efficacy and the severity of violence expressed of women under domestic violence
Design
The number of samples determined in each group is 57 people, considering the 10% drop, the number of samples in each group should be considered 63 people. Random allocator software will be used for random allocation.
Settings and conduct
Sampling in health centers and family physician bases in Sari and intervention at home and virtual.
Participants/Inclusion and exclusion criteria
The study population includes women who are married, have at least one year of experience living with their sexual partner, and are subjected to any form of sexual violence that causes (or is likely to cause) physical, sexual, or psychological harm to women. It is very painful for them or leads to forced deprivation of individual or social liberty, as well as being literate and willing to participate in the study.
Intervention groups
In the intervention group, first, a list of non-verbal music with the necessary characteristics to create relaxation is prepared with the opinion of a music expert and is presented to the participants of this group. After the participant selects their favorite music, they will receive 7 sessions of 45-minute (2 sessions per week) individually according to the Covid-19 pandemic conditions at home. Phone calls will be made twice a week and the researcher will monitor the intervention and homework. The interventions will be performed by a master's degree student in midwifery counseling under the direct supervision of a research team consisting of a reproductive health specialist, a doctorate in nursing, and a master's degree in music.
Main outcome variables
Self-efficacy; severity of expressed violence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N10
Registration date:2021-08-31, 1400/06/09
Registration timing:prospective
Last update:2021-08-31, 1400/06/09
Update count:0
Registration date
2021-08-31, 1400/06/09
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-16, 1400/07/24
Expected recruitment end date
2022-01-13, 1400/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of music on self-efficacy and the severity of violence expressed in women under domestic violence with control group
Public title
Music on self-efficacy and severity of expressed violence of women under domestic violence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married middle-aged and young women with experience of living with their husbands for at least a year and under domestic violence (according to the Parsa system)
Be able to read and write.
Have no habit of listening to music
No pregnancy
No chronic psychiatric disorders And major at the time of the study
No history of schizophrenia and bipolar disorder
No substance abuse
No participation in psychological intervention sessions related to domestic violence in the last 6 months
No use of antipsychotic drugs, antidepressants or mood stabilizers in Time of the study
No history of suicide attempt,
No history of hospitalization in the psychiatric ward (based on self-declaration)
Consent of the wife and her husband to participate in the study.
Exclusion criteria:
The patient's desire to leave the study
Occurrence of significant stressful events during the study (loss of a family member, job loss, bankruptcy, etc.)
Age
To 54 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign, use Random allocator software and (according to the number of 126 samples) two groups of numbers will be obtained randomly. Individuals will then be placed in intervention or control groups. For example, the numbers in group A will be women receiving the intervention and group B will be in control. Then, by referring to each of the women, we look at the table of numbers in which group they are and according to the table, they will be in the intervention or control group. This will be done for all participants. For example, the number one is in group B, which means that the first client is in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Research participants and staff of health centers.
While explaining the work, we only ask the health staff of the centers to provide us with the contact numbers of women who have been abused if these women agree, and we do not explicitly say, for example, that Ms. X is going to be in the control group or to intervene. We will explain the work process in general. Outcomes will be assessed by health centers' midwife that will not aware of participants' group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vicce chancellor for research of Mazandaran University of Medical Sciences, Moalem square
City
sari
Province
Mazandaran
Postal code
48178-57344
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.MAZUMS.REC.1400.272
Health conditions studied
1
Description of health condition studied
Women under domestic violence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy
Timepoint
At the time of enrollment - immediately after the intervention and one month after the intervention
Method of measurement
Schwartzer and Jurosalem General Self-Efficacy Questionnaire ( General Self- Efficacy Scale)
Secondary outcomes
1
Description
The severity of the violence expressed
Timepoint
At the time of enrollment - immediately after the intervention and one month after the intervention
Method of measurement
Domestic Violence Questionnaire against Women Mohseni Tabrizi et al
Intervention groups
1
Description
In the intervention group, they will receive 7 sessions of 45 minutes (2 sessions per week) individually according to the coronary pandemic conditions at home. Phone calls will be made twice a week and the researcher will monitor the intervention and homework. The interventions will be performed by a counseling master student in midwifery, under the direct supervision of a research team consisting of a reproductive health specialist, a doctoral nurse, and a music master. In this study, the meaning of music is non-verbal songs with the sound of nature such as wind and the sound of the sea wave and piano pieces that are uplifting and refreshing. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that inspires vitality and vitality away from excitement and impatience and is accompanied by stability and calmness, which is used by Standley music therapy through Mp3 player in each The meeting will be broadcast. In the first session, a folder containing non-verbal music will be played to the participant and based on their choice, it will be used until the end of the intervention. It should be noted that all non-verbal songs in the file will have the same theme and rhythm. In this study, the first, second and third methods of stand-up music therapy will be used for the intervention group. Passive music is a joy to listen to non-verbal pieces. A special melody to create joy in patients should have a refreshing musical theme. Invigorating themes (rhythmic) rhythmic pieces with a relatively sharp melody that induces vitality and vivacity away from excitement and impatience and is accompanied by stability and calm. Active Musical Activities in Music Therapy Sessions This study will include a discussion of musical emotions, singing, and speaking along with the piano.
Category
Treatment - Other
2
Description
Control group: Routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari health centers and Sari family doctors base
Full name of responsible person
Dr Aghil Barzegar
Street address
Amir Mazandarani St. - Kargar Square - Sari Health Center
City
sari
Province
Mazandaran
Postal code
4816711447
Phone
+98 11 3339 8913
Fax
+98 11 3339 8046
Email
purbarar.fatemeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr akbar hedayatizade omran
Street address
Research Center of Mazandaran University of Medical Sciences, Moallem Street - Moallem Square
City
sari
Province
Mazandaran
Postal code
4816717887
Phone
+98 11 3339 8330
Email
purbara.fatemeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
Associate Professor, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.,
City
sari
Province
Mazandaran
Postal code
481111111
Phone
+98 11 3336 8915
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Soghra khani
Position
Associate Professor, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh School of Nursing and Midwifery, Vesal Alley, Amir Mazandarani St.,
City
Sari
Province
Mazandaran
Postal code
48178-57344
Phone
+98 11 3336 8915
Email
s.khani@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Soghra Khani
Position
Modarator (owner) of [project/ PhD]
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Sexual and reproductive health research center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
48178-57345
Phone
+98 11 3336 8918
Fax
Email
s.khani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Research-related information is shared with the aim of keeping individuals' names and identities confidential and adhering to the 31 Code of Ethics.
When the data will become available and for how long
2022
To whom data/document is available
All researchers and research enthusiasts
Under which criteria data/document could be used
For review and supplementary research
From where data/document is obtainable
Author in charge of Dr. Soghar Khani
What processes are involved for a request to access data/document
She/He must first send an email to the author of the article and submit her request, and if the author and the research team deem it appropriate, the documents and files will be provided in a short time