NCT05260697

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

February 18, 2022

Last Update Submit

February 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • '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.

    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.

    1 year

Study Arms (2)

Sexual Counselling Group

EXPERIMENTAL

Sexual Counselling with PLISSIT model

Other: sexual counselling with plissit model

Control Group

NO INTERVENTION

no intervention group

Interventions

sexual counselling

Sexual Counselling Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen gender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve TUNCER

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Tuncer M, Yesiltepe Oskay U. Effect of sexual counseling on sexual function and sexual quality of life for women undergoing open heart surgery: a pilot randomized controlled trial. J Sex Med. 2023 Jun 28;20(7):1010-1017. doi: 10.1093/jsxmed/qdad065.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 2, 2022

Study Start

November 16, 2020

Primary Completion

December 30, 2021

Study Completion

April 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations