Effect of Guided Imagery with music (GIM) on Sexual Satisfaction and Sexual Function of Women with Sexual Dysfunction
Design
Three-stage clinical trial in two groups of control and intervention.
Settings and conduct
Comprehensive health care centers
Participants/Inclusion and exclusion criteria
Married women aged 19-49 years with sexual dysfunction; No history of surgery in participants and their husbands; Having mental and physical health
NO Premature menopause; Having a diploma and higher education; Having Iranian citizenship for couples; Women who do not live separately from their husbands at the time of the interview; Not having any known diseases that affect sexual function in participants or their husbands; Not consuming drugs that affect sexual function in participants or their husbands; Women who do not remarry; No history of sexual abuse in any life period based on what they say; At least one year has passed since their marriage; Not receiving any other treatment; Not participating in another clinical trial study similar to the present study; The consent of both couples to participate in the research; Not having experience of severe stress in any couple in recent years; Not being addicted to alcohol, cigarettes, and opioids in participants and their husbands; Not being pregnant and first trimester after delivery
Exclusion criteria: Occurrence of psychological and physical problems during the study; Unwillingness to continue collaborating during the study; Doing exercises less than half of the conducted sessions; Oral and anal sex
Intervention groups
Intervention is an audio file based on guided imagery with music (GIM) technique, in 30-minutes sessions twice a week for 6 weeks in women of reproductive age with sexual dysfunction. There will be no intervention for the control group and they will receive routine care.
Main outcome variables
Sexual Satisfaction and Sexual Function
General information
Reason for update
Acronym
GIM
IRCT registration information
IRCT registration number:IRCT20190806044460N1
Registration date:2020-01-09, 1398/10/19
Registration timing:prospective
Last update:2020-01-09, 1398/10/19
Update count:0
Registration date
2020-01-09, 1398/10/19
Registrant information
Name
Elahe Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3743 4144
Email address
elahe13mohammadi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Guided Imagery with Music (GIM) on sexual satisfaction and function of women with sexual dysfunction
Public title
Evaluating the effect of Guided Imagery with Music (GIM) on sexual satisfaction and function of women with sexual dysfunction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 19-49 years with sexual dysfunction
No history of surgery in participants and their husbands
Having mental and physical health
NO Premature menopause
Having a diploma or higher education
Having Iranian citizenship for couples
Women who do not live separately from their husbands at the time of the interview
Not having any known diseases that affect sexual function in participants or their husbands
Not consuming drugs that affect sexual function in participants or their husbands
Women who do not remarry
No history of sexual abuse in any life period based on what they say
At least one year has passed since their marriage
Not receiving any other treatment
Not participating in another clinical trial study similar to the present study
The consent of both couples to participate in the research
Not having experience of severe stress in any couples in recent years
Not being addicted to alcohol, cigarettes, and opioids in the participants and their husbands
Not being pregnant and first trimester after delivery
Exclusion criteria:
Occurrence of psychological and physical problems for women during the study
Unwillingness to continue collaborating during the study
Doing exercises less than half of the conducted sessions
Oral and anal sex
Age
From 19 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Selected samples randomly divide into intervention and control groups. In this way, two health centers are randomly selected for intervention group and two centers for control group.
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 in Research Vice chancellor for research - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.505
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function score
Timepoint
Before, immediately after the intervention, and one month after the intervention
Method of measurement
The Female Sexual Function Index (FSFI)
2
Description
Sexual satisfaction score
Timepoint
Before, immediately after the intervention, and one month after the intervention
Method of measurement
Larson' s Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention in the present study will be based on the Guided Imagery with Music (GIM) technique. The intervention will be performed in 30 minutes sessions twice a week for 6 weeks. The first session will be 45-90 minutes in community health center and 11 sessions at home with researcher-made GIM audio file.
Category
Treatment - Other
2
Description
Control group: There will be no intervention for the control group and they will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Care Centers of Isfahan
Full name of responsible person
Dr Reza Khadivi
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۳۷۴
Phone
+98 31 1677 5199
Email
Health@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱ -۸۱۷۴۶
Phone
+98 31 1677 5199
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahshid Abdi Shahshahani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street, Azadi square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 1677 5199
Email
m_abdi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahshid AbdiShahshahani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street, Azadi square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 913 167 7519
Email
m_abdi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Mohammadi
Position
MSc Student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 82 , Dead end 6, Vahdat alley,Imam street
City
Falavarjan
Province
Isfehan
Postal code
8451814313
Phone
+98 31 3742 0362
Email
elahe13mohammadi@nm.mui.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Protocol of study and reporting of study in the form of articles and theses
When the data will become available and for how long
since it released forever
To whom data/document is available
everyone
Under which criteria data/document could be used
No more information
From where data/document is obtainable
Library or magazine site where the article is published
What processes are involved for a request to access data/document