The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life

February 18, 2022 updated by: Merve Tuncer, Istanbul University - Cerrahpasa (IUC)
This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Increasing the quality of life in the rehabilitation process after cardiac surgery and facilitating adaptation to life after surgery; but not enough.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Volunteering to participate in the research
  • Being a woman
  • Being over 18 years old
  • Willingness to undergo open heart surgery
  • Euroscore score ≤ 6 (low mortality risk due to cardiac surgery)
  • Being sexually active
  • Absence of sexual health problems in the spouse
  • Ability to communicate verbally and be literate
  • Women without neurological or psychiatric disorders
  • Knowing Turkish

Exclusion Criteria:

  • Unwillingness to participate in the research
  • Euroscore score >6 (high risk of mortality)
  • Not being sexually active
  • Having a diagnosed sexual health problem in the spouse
  • Women with neurological and psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sexual Counselling Group
Sexual Counselling with PLISSIT model
Other: sexual counselling with plissit model
sexual counselling
No Intervention: Control Group
no intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
'Female Sexual Function Index' scores will increase after sexual counseling based on the PLISSIT model will be given to individuals who will undergo open heart surgery.
Time Frame: 1 year
1 year
After the sexual counseling based on the PLISSIT model to be given to the individuals who will undergo open heart surgery, the scores of the "Sexual Quality of Life Scale-Female Form" will increase.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 13022260-302.14.05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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