Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.

Completed

• Conditions: Endometriosis; Sleep
• Interventions: Other: Pittsburgh Sleep Quality Index.; Other: Epworth sleepiness scale.; Other: Insomnia Severity Index.; Other: The Endometriosis Health Profile.

• Registration Number: NCT02027142
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Brief Summary

This study included women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls). In this age-matched case-control study, the aimdy was to assess quality of sleep, the average daytime sleepiness and insomnia in patients with endometriosis by using three different self-reported questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

Reproductive age Surgical and histological diagnosis of rectovaginal endometriosis

Exclusion Criteria

Suspicion of endometriosis (based on evaluation of symptoms, gynaecological examination and transvaginal ultrasonography) History of infertility Previous diagnosis of endometriosis Gynaecological, intestinal and urological diseases causing abdominal pain (e.g. pelvic congestion syndrome, bladder pain syndrome) Severe underlying comorbidities (cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological, or psychiatric) Pregnancy at any gestational age Suspicion or diagnosis of oncological pathology Use of gonadotropin releasing hormone analogues (GnRH-a) Restless legs syndrome Shift work Use of antiallergic drugs Narcotics Refusal or inability to sign the informed consent form or complete the study questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Epworth sleepiness scale.	Women referred to two academic centres for the diagnosis and treatment of endometriosis.
Cases	Pittsburgh Sleep Quality Index.	Women referred to two academic centres for the diagnosis and treatment of endometriosis.
Cases	Insomnia Severity Index.	Women referred to two academic centres for the diagnosis and treatment of endometriosis.
Cases	The Endometriosis Health Profile.	Women referred to two academic centres for the diagnosis and treatment of endometriosis.
Controls	Pittsburgh Sleep Quality Index.	Women referred to our Institutions because of routine gynaecologic consultations.
Controls	Epworth sleepiness scale.	Women referred to our Institutions because of routine gynaecologic consultations.
Controls	Insomnia Severity Index.	Women referred to our Institutions because of routine gynaecologic consultations.

Primary Outcome Measures

Name	Time	Method
Quality of sleep.	Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.	Quality of sleep was assessed by using the Pittsburgh Sleep Quality Index.

Secondary Outcome Measures

Name	Time	Method
Insomnia.	Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.	Insomnia was assessed by using the Insomnia Severity Index.
Average daytime sleepiness.	Cases were administered and fulfilled the questionnaires at the moment of being scheduled for surgery (3-4 months before the operation). Controls were administered and fulfilled the questionnaires after routine gynaecologic consultation.	Average daytime sleepiness was assessed by using the Epworth sleepiness scale.

Trial Locations

Locations (2)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro; 🇮🇹 Genoa, Ligury, Italy

IRRCS San Raffaele Hospital and Vita-Salute San Raffaele University; 🇮🇹 Milan, Lombardy, Italy