Protocol summary
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Study aim
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Determination of the effect of acupressure on sexual function of women taking antidepressants in comparison with placebo
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Design
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This study is a randomized clinical trial study that will be performed on 120 patients taking antidepressants medical office of project's physician Yasuj, Iran in 2020.
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Settings and conduct
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In intervention group, acupressure at point PC6 and sp6 for ten minutes at each point, twice a week for two month and in control group, acupressure at placebo point P1 and P2 for ten minutes at each point, twice a week for two months. Female sexual function index questionnaire will be completed before and two months after the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Desire to participate in the study, Age 18-45 years
Literacy for reading and writing, Score less than 20 and diagnose mild to moderate depression on the Hamilton scale,2 hours after the last meal
At least 4 weeks of treatment with antidepressant drugs affect sexual function
Married and having a sexual partner who is present at least 50% of the month. Exclusion criteria:Unwillingness to participate in the study, Presence of infectious and skin diseases, acute rheumatoid arthritis, wounds or skin infections at the site of acupressure intervention, Existence of speech or hearing problems, Addiction and alcohol using in person or his partner
Sexual problems before taking antidepressants, Loss of relatives or friends in the last six months, Chronic diseases such as cardiovascular, thyroid, arthritis, diabetes, epilepsy, kidney disorders
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Intervention groups
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Intervention group: Acupressure at point PC6 and sp6 for ten minutes at each point, twice a week for two months.
Control group: Acupressure at placebo point P1 and P2 for ten minutes at each point, twice a week for two months.
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Main outcome variables
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Score of sexual function based on Female sexual function index questionnaire
General information
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Reason for update
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revised of blindness
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160524028038N10
Registration date:
2020-12-27, 1399/10/07
Registration timing:
registered_while_recruiting
Last update:
2024-04-15, 1403/01/27
Update count:
1
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Registration date
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2020-12-27, 1399/10/07
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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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2020-12-05, 1399/09/15
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Expected recruitment end date
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2021-03-19, 1399/12/29
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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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The effect of acupressure on sexual function of women taking antidepressants in comparison with placebo
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Public title
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Acupressure and the sexual function of women taking antidepressants
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Desire to participate in the study
Age 18-45 years
Literacy for reading and writing
Score less than 20 and diagnose mild to moderate depression on the Hamilton scale
2 hours after the last meal
At least 4 weeks of treatment with antidepressant drugs affect sexual function
Married and having a sexual partner who is present at least 50% of the month
Exclusion criteria:
Unwillingness to participate in the study
Presence of infectious and skin diseases, acute rheumatoid arthritis, wounds or skin infections at the site of acupressure intervention
Existence of speech or hearing problems
Addiction and alcohol using in person or his partner
Sexual problems before taking antidepressants
Loss of relatives or friends in the last six months
Chronic diseases such as cardiovascular, thyroid, arthritis, diabetes, epilepsy, kidney disorders
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Age
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From 18 years old to 45 years old
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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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- Participant
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization method is simple. The random allocation sequence will be determined using the "computer Random generation" computer program. The sealed envelopes encoded and non-transparent (A and B) for the allocation of subjects to intervention (A) and control (B) groups will be used.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The double-blind method was such that the research units (after obtaining informed consent) and the data analyst were not aware of the allocation of the study groups.
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Placebo
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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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2020-11-25, 1399/09/05
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Ethics committee reference number
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IR.YUMS.REC.1399.159
Health conditions studied
1
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Description of health condition studied
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Sexual dysfunction
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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Score of sexual function based on Female sexual function index questionnaire
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Timepoint
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Before and two months after the intervention
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Method of measurement
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Female sexual function index questionnaire
Intervention groups
1
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Description
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Intervention group: Acupressure at point PC6 and sp6 for ten minutes at each point, twice a week for two months.
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Category
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Treatment - Other
2
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Description
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Control group: Acupressure at placebo point P1 and P2 for ten minutes at each point, twice a week for two months.
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Category
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Placebo
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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Yasouj 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