GENERAL OBJECTIVES: Determining Effectiveness of PLISSIT sexual counseling model on Sexual self-perception and Adjustment, and Sexual Function of women with acute coronary syndromes
SPECIFIC OBJECTIVES: 1)Determine and compare the level of Sexual self-perception and Adjustment of women with acute coronary syndromes before, one month and three months after the intervention in the intervention and control group. 2) Determine and compare the sexual function of women with acute coronary syndromes before, one month and three months after intervention in the intervention and control group
Design
Randomized, controlled clinical trial, in parallel with a control group
Settings and conduct
Samples were randomly assigned to control and control groups in Shahid Rajaie Heart Hospital of Karaj, who were hospitalized for diagnosis of acute coronary artery disease.
Participants/Inclusion and exclusion criteria
Married women who live in Karaj
Every woman has to a reading and writing literacy
sexual active before admitted
A definitive diagnosis of acute coronary syndrome based on angiography, dynamic band changes, serial serum elevations of enzymes, previous angiographic records, exercise tests, or previous positive scans with angina pectoris
Aged between 30-65
Intervention groups
Sexual counseling with the PLISSIT model will be performed for an intervention group within three weeks and counseling sessions will be held for one hour. The questionnaires will be completed before the intervention and again within a month and three months later. Educational curiosity will be given to the control group
Main outcome variables
sexual function
self sexual perception
General information
Reason for update
Acronym
PLSSIT
IRCT registration information
IRCT registration number:IRCT20161230031662N6
Registration date:2018-07-17, 1397/04/26
Registration timing:registered_while_recruiting
Last update:2018-07-17, 1397/04/26
Update count:0
Registration date
2018-07-17, 1397/04/26
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of PLISSIT sexual counseling model on Sexual self-perception and Adjustment, and Sexual Function of women with acute coronary syndromes
Public title
Effectiveness of Sexual Function and Adjustment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who live in Karaj
Every woman has to a reading and writing literacy
sexual active before admitted
A definitive diagnosis of acute coronary syndrome based on angiography, dynamic band changes, serial serum elevations of enzymes, previous angiographic records, exercise tests, or previous positive scans with angina pectoris
Aged between 30-65
Exclusion criteria:
There are symptoms of heart failure or pulmonary edema or cardiogenic shock (shortness of breath, runny ear in the lung, hypotension)
The patient's unwillingness to continue to be present in the research
Missing more than one meeting in consultation
Serious psychological problems
Serious problems affecting sexual function
Participate in similar studies or receive similar care with research intervention
Sexual abnormalities in the patient's wife
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Accidentally with random blocks
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
Alborz University of Medical Sciences
Street address
North Taleghani- Azimiyeh
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.ABZUMS.REC.1397.030
Health conditions studied
1
Description of health condition studied
Acute coronary syndromes
ICD-10 code
124.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention, one month and three months after intervention
Method of measurement
Female Sexual Function Index
2
Description
Sexual self_perception and adjustment
Timepoint
Before intervention, one month and three months after intervention
Method of measurement
Sexual self_perception and adjustment questionarie
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 women with acute coronary syndrome entered the study according to entry criteria. They will be admitted to the third to fifth day and will be consulted within three weeks( weekly). Each counseling session will take about an hour. Consultation sessions will proceed according to the PLISSIT method until the third step.
Category
Behavior
2
Description
Control group: 30 women with acute coronary syndrome entering the study are enrolled. This tutorial will be given to this group.