NCT06017128

Brief Summary

This study investigates the influence of sexual counseling using the PLISSIT model on various aspects of patients undergoing hip replacement. The PLISSIT model is employed to guide the counseling process. The research aims to assess how this counseling intervention affects sexual function, quality of life, and overall comfort for these patients. By addressing these factors, the study seeks to shed light on potential improvements in the well-being and experiences of individuals who have undergone hip replacement surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

August 22, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

August 22, 2023

Last Update Submit

November 16, 2024

Conditions

Keywords

Hip ArthropatySexual Function

Outcome Measures

Primary Outcomes (2)

  • Female Sexual Function Index

    The highest score that can be obtained from the scale is 36 and the lowest score is 2. The cut-off score of the scale is 26.55. Those with a score of 26.55 or less are considered to have female sexual dysfunction. Female Sexual Function Index scores will increase after education according to PLISSIT Model.

    8 months

  • International Index of Erectile Function

    The severity of erectile function in this area with a maximum score of 30; severe (6-10 points), moderate (11-16 points), mild (17-25 points) and no dysfunction (26 30 points). International Index of Erectile scores will increase after education according to PLISSIT Model.

    8 months

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group will consist of individuals who will undergo total hip replacement surgery and receive sexual counseling along with an educational booklet.

Other: sexual counseling based on the PLISSIT model

Control

NO INTERVENTION

The control group will be comprised of individuals undergoing total hip replacement surgery without receiving sexual counseling.

Interventions

In the initial follow-up, the experimental group will receive information about total hip replacement surgery and its impact on sexual life based on the PLISSIT model. An educational booklet containing information about total hip replacement surgery, the rehabilitation process, and post-operative sexual life will also be prepared and distributed. In the second follow-up (5-7 days after surgery), the experimental group will be provided with information about home care before discharge and returning to sexual life.

Intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18 to 70.
  • Willingness to participate in the study.
  • Scheduled to undergo hip replacement surgery.
  • Being sexually active.
  • Ability to engage in verbal communication and being literate.

You may not qualify if:

  • Having a diagnosed history of a sexual disease in oneself or in one's partner (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).
  • Having diagnosed neurological and psychiatric disorders (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Related Publications (6)

  • Faghani S, Ghaffari F. Effects of Sexual Rehabilitation Using the PLISSIT Model on Quality of Sexual Life and Sexual Functioning in Post-Mastectomy Breast Cancer Survivors. Asian Pac J Cancer Prev. 2016 Nov 1;17(11):4845-4851. doi: 10.22034/APJCP.2016.17.11.4845.

    PMID: 28030909BACKGROUND
  • Issa K, Pierce TP, Brothers A, Festa A, Scillia AJ, Mont MA. Sexual Activity After Total Hip Arthroplasty: A Systematic Review of the Outcomes. J Arthroplasty. 2017 Jan;32(1):336-340. doi: 10.1016/j.arth.2016.07.052. Epub 2016 Aug 11.

    PMID: 27612606BACKGROUND
  • Ibrahimoglu O, Gezer N, Ogutlu O, Polat E. The Relationship Between Perioperative Care Quality and Postoperative Comfort Level in Patients With Hip Replacement Surgery. J Perianesth Nurs. 2023 Feb;38(1):69-75. doi: 10.1016/j.jopan.2022.05.068. Epub 2022 Aug 3.

    PMID: 35931599BACKGROUND
  • Miettinen HJA, Makirinne-Kallio N, Kroger H, Miettinen SSA. Health-Related Quality of Life after Hip and Knee Arthroplasty Operations. Scand J Surg. 2021 Sep;110(3):427-433. doi: 10.1177/1457496920952232. Epub 2020 Aug 31.

    PMID: 32862793BACKGROUND
  • Saray Kilic H, Tastan S. Development of post hip replacement comfort scale. Appl Nurs Res. 2017 Dec;38:169-174. doi: 10.1016/j.apnr.2017.10.004. Epub 2017 Oct 16.

    PMID: 29241512BACKGROUND
  • Tuncer M, Oskay UY. Sexual Counseling with the PLISSIT Model: A Systematic Review. J Sex Marital Ther. 2022;48(3):309-318. doi: 10.1080/0092623X.2021.1998270. Epub 2021 Nov 17.

    PMID: 34789082BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Merve Tuncer, PhD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Individuals will be included in the groups using the randomization method. The randomization of the groups was conducted using the simple-random technique through the use of the website www.random.org.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This randomized controlled, pre-test-post-test measurement experimental study was designed to determine the impact of sexual counseling based on the PLISSIT model on sexual function, quality of life, and comfort levels in individuals who have undergone total hip replacement surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 30, 2023

Study Start

November 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

The researchers will make decisions based on the study outcomes.

Locations