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Sexual Function Questionnaire Total Hip Replacement

5. September 2018 aktualisiert von: University Hospital Southampton NHS Foundation Trust

Development and Validation of a Sexual Function Questionnaire for Female Patients Undergoing Total Hip Replacement

  • Non-commercial trial
  • 2 Centres involved: University Hospital Southampton and Spire Southampton
  • Expected number of eligible participants available per year: 100, (95% expected to agree to participation)
  • The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.
  • This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:

Retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14

Prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14

This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Prospective

Patients will be recruited from clinics at University Hospital Southampton and Spire Southampton Hospital. If they agree in principle to participate they will be provided with the Patient Information Sheet (PIS) and consent forms. Having completed the consent forms (one for participant to keep and one for the site file) participants are assigned an alphanumeric study number, which will be written at the top of all questionnaires and research paperwork completed. A form detailing demographic information will be filled out on recruitment to provide data for comparative quantitative analysis.

Prior to their operation, whether in hospital or by post (patient preference), they will complete a pre-operative ASFQ and FSFI questionnaire. These will be returned to the research team either in person (if completed by an inpatient) or returned in a pre-stamped addressed envelope. Copies of the National Joint Registry (NJR) data and PROMs will also be made and kept for evaluation alongside the questionnaire data. Patients will then complete the post-operative questionnaires and FSFI validated questionnaire at 6 and 12 months after their surgery. Questionnaires will be distributed to the patients in clinic at 6 months and sent to their home address at 12 months post-operatively (returned with stamped and addressed envelope).

Retrospective

Potential participant will be highlighted from previous inpatient list of patients eligible for participation. These patients will be contacted via telephone by a Good Clinical Practice (GCP) trained member of the research team member and invited to participate in the trial. If keen a PIS will be sent out to the patient's home address. The research team member will then follow-up with a phone-call to gain implied consent and complete an additional form detailing demographic information (the same information as the prospective cohort). The post-operative questionnaire, FSFI questionnaire and consent forms (one for participant to keep and one for the site file) with a stamped address envelope, will then be sent out to the participant to complete. Once documents are completed they will be returned to the research team. Questionnaires will be sent out at 6 and 12 months post-op where possible. Maximum time retrospective recruitment will be 12 months. The patient's NJR and PROMs will also be accessed for evaluation alongside the questionnaire data.

Studientyp

Beobachtungs

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
    • Hampshire
      • Southampton, Hampshire, Vereinigtes Königreich, SO16 6UY
        • Spire Southampton Hospital
      • Southampton, Hampshire, Vereinigtes Königreich, SO16 6YD
        • University of Southampton NHS Foundation Trust

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

All female patients aged over 18 that are listed for a total hip replacement at University Hospital Southampton NHS Foundation Trust and The Spire Hospital Southampton that fulfill the inclusion criteria will be asked to participate.

Beschreibung

Inclusion Criteria:

  • Female
  • Sexually active
  • Heterosexual
  • 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year

Exclusion Criteria:

  • Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively
  • Unable to comprehend English and with capacity to consent and follow instruction
  • Unable to sign and date the ethics committee approved consent documentation

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Retrospektive

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Prospective
Prospective - Factors affecting sexual function pre-THR
Sonstiges: Prospective - Factors affecting sexual function pre-THR

A prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement.

Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation.

Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI.
Retrospective
Retrospective- Factors affecting sexual function post-THR
Sonstiges: Retrospective- Factors affecting sexual function post-THR

A retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year.

Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible).

Maximum retrospective collection of data 12 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
Zeitfenster: 2 years
To determine those patient and implant factors that affect sexual activity after hip replacement surgery. The study data will be used to publish an evidence-based patient information booklet that will be a standard reference for patients and healthcare professionals.
2 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
Zeitfenster: 2-5 years
The study will be extended to collect data from patients with knee arthritis who undergo knee replacement surgery (partial and total), as well as the partners of patients with hip and knee replacements. The study will also be extended to patients who have pre-arthritic conditions such as femoro-acetabular impingement, who undergo arthroscopic procedures.
2-5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital Southampton NHS Foundation Trust

Ermittler

  • Hauptermittler: Joanna C D'Souza, BM BSc(Hons), Research Fellow, UHS NHS FT.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Oktober 2014

Primärer Abschluss (Voraussichtlich)

1. Juni 2018

Studienabschluss (Voraussichtlich)

1. Juli 2018

Studienanmeldedaten

Zuerst eingereicht

3. November 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. November 2014

Zuerst gepostet (Schätzen)

14. November 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. September 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 12/SC/0296

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