NCT05808959

Brief Summary

An active sex life has an important place for the quality of life and is closely related to the increase in the general health level. In this context, a healthy sexual life after TKA surgery can contribute to the general quality of life of the patients. In the pre-TKA period, the sexual activity of female patients was found to be impaired more than men, the relationship between spouses was significantly affected negatively, and in the post-TKA period, general sexual recovery was significantly delayed in female patients compared to men. From this perspective, it is clear that pre- and post-TKA sexual counseling is important when preparing a balanced resumption of sexual activity in female patients after TKA. However, in clinical practice, patients may hesitate to talk about sexual life, and orthopedists and nurses often ignore this.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

April 27, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

March 17, 2023

Last Update Submit

April 29, 2024

Conditions

Outcome Measures

Primary Outcomes (8)

  • Sexual function-first evaluation

    Sexual function will be evaluated 4 times in the perioperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.

    before surgery

  • Sexual function-second evaluation

    Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.

    1 month after surgery

  • Sexual function-third evaluation

    Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.

    3 month after surgery

  • Sexual function-fourth evaluation

    Sexual function will be evaluated 4 times in the postoperative period.Data will be collected with the Female Sexual Function Questionnaire Index. The highest score that can be obtained from the scale is 45, and as the total score decreases, it is considered as a decrease in sexual function.

    6 month after surgery

  • Sexual Quality of Life--first evaluation

    Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.

    before surgery

  • Sexual Quality of Life--second evaluation

    Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.

    1 month after surgery

  • Sexual Quality of Life--third evaluation

    Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.

    3 month after surgery

  • Sexual Quality of Life--fourth evaluation

    Sexual quality of life will be evaluated 4 times in the perioperative period.Data will be collected with the Sexual Life Quality Scale-Female (CYKÖ-K). The score that can be obtained from the scale is between 18-108. A high score from the scale indicates that the quality of sexual life is good.

    6 month after surgery

Secondary Outcomes (8)

  • Fear of sexual activity-first evaluation

    before surgery

  • Fear of sexual activity-second evaluation

    1 month after surgery

  • Fear of sexual activity-third evaluation

    3 month after surgery

  • Fear of sexual activity-fourth evaluation

    6 month after surgery

  • satisfaction with sexual activity-first evaluation

    before surgery

  • +3 more secondary outcomes

Study Arms (2)

Education group

EXPERIMENTAL

Structured training on sexual health will be given to patients in this group. After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health. It is anticipated that the training will take approximately 30 minutes. Immediately after the training, feedback will be received from the patient through a question-answer activity, and areas that are not understood will be repeated. It is thought that the training will take approximately 45-60 minutes in total.

Behavioral: Education group

Control group

NO INTERVENTION

The clinic's routine discharge training will be applied to the participants in the control group.

Interventions

Education groupBEHAVIORAL

After the discharge training given at the clinic in the postoperative period, the participants will be given structured training on sexual health.

Education group

Eligibility Criteria

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

You may qualify if:

  • \>18-\<65 years old,
  • have no barriers to communicating,
  • able to understand and speak Turkish,
  • sexually active before and after TKA,
  • with her husband,
  • patients without sexual dysfunction will be included.

You may not qualify if:

  • having a history of spinal surgery,
  • having cancer,
  • developing surgical site infection after TKA,
  • do not complete the study,
  • developing any complications during the working process,
  • patients who lost their lives during the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice ÖNER CENGİZ

Altındağ, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

SexualityMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Hatice ÖNER CENGİZ

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 12, 2023

Study Start

April 27, 2023

Primary Completion

April 5, 2024

Study Completion

April 5, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations