Protocol summary
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Study aim
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determine the effect of councelling program on sexual knowledge and quality of life and DASS21 score of patients(men) after Invasive coronary intervention
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Design
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This study is a clinical trial (phase 3) with a control group, with parallel groups, single-blind, randomized, on 56 patients. All male patients with inclusion and exclusion criteria were entered into the study and randomly allocated to the groups by the Rand calculator function.
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Settings and conduct
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In the post cath ward of Shahid Beheshti hospital in Kashan, at the time of discharge, patients were evaluated and after being allocated to study groups, the researcher provided training and counseling to patients.
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Participants/Inclusion and exclusion criteria
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Married male patients; aged 35-65 years; undergoing CABG and PTCA treatment; no severe physical illness, addiction, known psychiatric problem, or previous sexual dysfunction at the time of discharge.
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Intervention groups
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Patients who received sexual activity guidance counseling at discharge were called an intervention group, and the control group was provided with routine nursing training, and no intervantion counseling was provided.
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Main outcome variables
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Sexual knowledge; sexual quality of life
General information
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Reason for update
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adding extra secondary outcome
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100829004655N8
Registration date:
2018-03-19, 1396/12/28
Registration timing:
prospective
Last update:
2021-07-20, 1400/04/29
Update count:
1
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Registration date
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2018-03-19, 1396/12/28
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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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2018-02-20, 1396/12/01
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Expected recruitment end date
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2018-09-22, 1397/06/31
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Actual recruitment start date
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2018-04-04, 1397/01/15
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Actual recruitment end date
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2018-09-06, 1397/06/15
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Trial completion date
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2018-11-22, 1397/09/01
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Scientific title
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Effect of sexual counseling on knowledge, Sexual Quality of Life and DASS21 score in post CABG and PTCA patients (men)
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Public title
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Effect of discharge counselling on knowledge and Sexual Quality of Life and DASS21 score in patients (men)
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
patient can read and write
patient must be married and living with partner
Exclusion criteria:
heart, liver, pulmonary and kidney failure or malignancy or any systemic disease
use of antipsychotic or cytotoxic drug
severe heart failure (function class III or IV (NYHA))
alcohol or opium abuse (based on the patient statement)
existence of current depression, anxiety, stress based on DASS-21 score (depression score<10 or anxiety score<8 or stress score<15)
current known sexual dysfunction
current known psychological disorder
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Age
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From 35 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
45
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sampling method was continuous, and all male patients admitted during the study who had inclusion criteria were admitted to the study at the time of discharge and remained in the study if they did not have exclusion criteria. Then they were allocated to the intervention or control group randomly by random computer numbers (calculator). Conventionally in the study, random multiple numbers 2 placed the patient in the intervention group, and non-multiple random numbers 2 placed the patient in the control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All patients were aware that they were participating in the study and that the intervention was a form of counseling. But he did not know which group he belonged to. In this way, the members of both groups were visited by the researcher at the time of discharge and 2 months later by the follow-up of the researcher. But in the intervention group, during the researcher's visit, counseling and training were also provided. In the control group, routine nursing training was repeated during the researcher's visit and no counseling was provided.
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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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2018-01-01, 1396/10/11
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.97
Health conditions studied
1
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Description of health condition studied
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Chronic ischemic heart disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic ischemic heart disease, unspecified
Primary outcomes
1
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Description
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sexual knowledge
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Timepoint
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baseline and 2 month after dischage
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Method of measurement
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sexual knowledge questionnaire in cardiac patient
2
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Description
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sexual quality of life
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Timepoint
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baseline and 2 month after dischage
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Method of measurement
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Abraham sexual quality of life questionnaire
Secondary outcomes
1
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Description
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depression
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Timepoint
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baseline and 2 month after dischage
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Method of measurement
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DASS21 quesionaire
2
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Description
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anxiety
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Timepoint
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baseline and 2 month after dischage
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Method of measurement
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DASS21 quesionaire
3
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Description
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stress
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Timepoint
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baseline and 2 month after dischage
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Method of measurement
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DASS21 quesionaire
Intervention groups
1
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Description
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Intervention group: Providing face-to-face counseling to the patient during discharge in 1 session for 20 minutes - In addition to face-to-face educational counseling, patients also received an educational package containing DVD videoclip and an educational brochure containing scientific information.
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Category
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Rehabilitation
2
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Description
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Control group: Receiving the usual training program during discharge that lasted 20 minutes in 1 session and routine nursing and training information that is provided to all patients was provided to this group of patients.
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Category
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Rehabilitation
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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Kashan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is 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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Not applicable
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Title and more details about the data/document
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The total potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Only available to scholars working in academia and academia.
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Under which criteria data/document could be used
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If you observe the trust and mention the source, data is available for researchers.
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From where data/document is obtainable
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Send the following e-mail to the following address: taghadosi_m@kaums.ac.ir
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What processes are involved for a request to access data/document
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After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.
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Comments
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